Stemcentrx ™ is focused on scientific discovery and development of successful cancer drugs. We are funded by scientists and entrepreneurs with a long-term perspective on our business. Our culture is an apolitical meritocracy where performance and teamwork are rewarded. Stemcentrx has assembled a talented and motivated team, and is looking to recruit additional employees with world-class expertise in their practice, versatility to contribute broadly across the company, high energy and an entrepreneurial spirit.
Drug Safety Senior Manager / Associate Director
As part of a talented and multi-disciplinary team advancing an exciting approach to cancer drug development, we are seeking an this individual who is responsible for establishment of the Case Management/Operations function and for support of ongoing risk management /signal evaluation activities. He/she works closely with the Head of Drug Safety to assure that all departmental procedures are developed in accordance with US and/or global regulatory requirements. Procedures include but are not limited to Standard Operating Procedures (SOPs), safety agreements, data entry conventions, work processes and Drug Safety database procedures. Such procedures will apply to both the pre and post-approval periods of Stemcentrx' products.
1. Establish and lead the Case Management team to include all pharmacovigilance activities associated with Individual Case Safety Report (ICSR) processing and reporting of adverse events in accordance with local regulations and company procedures
a. Report collection, data entry, narrative generation, determination of follow-up.
2. Accountable for mentoring, coaching and development of direct reports by providing an environment that encourages ongoing personal and professional development
b. Clinical review, assessment of relatedness and expectedness, MedDRA coding and coordination of medical review of ICSR
c. Perform AE/SAE reconciliation, adverse event and concomitant medication coding
3. Responsible for the performance of assigned personnel against departmental processes, standards and performance goals and for ensuring successful completion of all training required for the role
4. Author and review updates and new documents, processes or activities to create unified and consistent safety-related procedures within the department
5. Demonstrates seamless collaboration with other departments for delivery of drug safety services, process improvement initiatives and to provide guidance for cross-functional team activities
6. Assist with the preparation of safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, IND annual reports, integrated summaries of safety or other periodic reports)
7. Management of outsourced safety data collection activities with CROs: lead the preparation, review and approval of new or updated documentation to support standardizing outsourced activities (e.g. safety management plans and budgets); assure seamless transition of applicable activities to an in-house model
8. Act as the safety liaison/resource on study project teams for safety-related issues arising from any Stemcentrx’ clinical development program
9. Under the guidance of the manager will collaborate with corporate partners for clinical trial and post-marketing pharmacovigilance activities (i.e. pharmacovigilance agreements)
10. Participate in regulatory inspections and internal audits as needed
11. Contribute to the development and implementation of the strategic direction for case management functional team and department
12. Detail oriented with the ability and desire to work in a fast paced, team oriented small company environment with the ability to manage simultaneous priorities and challenging deadlines
b. Clinical review, assessment of relatedness and expectedness, MedDRA coding and coordination of medical review of ICSR
c. Perform AE/SAE reconciliation, adverse event and concomitant medication coding
1. BS Pharmacy, PharmD, BS RN degree with critical care management background preferred or equivalent
2. Five years experience in Drug Safety in a biopharmaceutical environment is preferred
3. Demonstrated knowledge of domestic and international regulatory safety reporting requirements
4. Must have excellent organizational skills
5. Strong communications skills (verbal and written)
6. Experience with the use of drug safety databases (e.g., Argus, ARISg, etc.)
7. Normally receives minimal instruction on routine work and may need general instruction on new projects
8. Ability to sit and type on computer keyboard for long periods of time
9. Previous management experience preferred
As part of a talented and multi-disciplinary team advancing an exciting approach to cancer drug development, we are seeking a highly motivated project manager who will work with functional area teams, project team leaders and senior management to direct projects to successful and timely decision points. The project manager will be responsible for overseeing teams through drug discovery and development processes while prioritizing activities across multiple projects.
The ideal candidate must be detail oriented, highly organized, has excellent interpersonal skills, and thrives in a fast-paced environment. This opportunity will provide exposure to various facets of antibody drug development from early stage research through IND filing.
1. Support the development and execution of project plans, including timing and deliverables, to achieve the project goals and ensure adherence to timeline.
2. Develop and maintain timelines to track milestones and other program activities
3. Provide progress reports and updates on project status as required.
4. Identify and anticipate issues that threaten to delay timelines. Bring these issues to the attention of key stakeholders.
5. Provide support in resolving issues, contingency planning, and risk mitigation.
6. Support PTLs in organization of project team meetings by contributing agendas and recording minutes and action items.
7. Prioritize program activities across multiple projects within the company’s pipeline.
8. Act as a primary contact for project team related information.
9. Identify, recommend, and implement opportunities for streamlining team processes.
1. B.S. or B.A. in Life Sciences with 3+ years of experience in biotech/pharmaceutical industry.
2. Multi-disciplinary knowledge of the biotech industry or direct experience with project management in drug development is preferred.
3. Proficiency with Microsoft Office including Project, Word, PowerPoint, and Excel.
4. Experience in or ability to learn project management practices, tools, and methodology in drug development.
5. Demonstrated ability to work well with others in a multicultural environment.
6. High attention to detail and extremely organized.
7. Good analytical and planning skills with the ability to translate vision into action.
8. Strong communication skills both written and oral.
9. Ability to adapt to changing priorities.
10. Ability to multitask and meet deadlines in a fast-paced environment is essential.
Antibody Discovery - Research Associate / Associate Scientist
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will participate in a variety of activities to discover, design and construct humanized and fully human antibodies. The ideal candidate should be experienced and skillful in a wide range of molecular biology methods, including molecular cloning and site directed mutagenesis, and have an interest in antibody or protein engineering. The position requires excellent laboratory skills, critical thinking, and attention to detail at the bench and the desk.
1. B.S/M.S in Molecular Biology, Immunology or a related field is required, with at least 2 years of biotech industry experience.
2. Proficient in standard molecular biology techniques (such as molecular cloning, site directed mutagenesis). Experience with library construction is a plus.
3. Knowledge and experience with the analysis of antibody sequences is highly preferred.
4. Experience with phage display is a plus.
5. Ability to multitask and meet deadlines in a fast-paced, environment
6. Ideal candidates must be motivated, organized, and disciplined with record keeping
7. Great personality and excellent communication skills
Antibody Discovery - Research Associate / Scientist
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute to recombinant protein expression, purification and validation. They will also play a major role in discovery and characterization of therapeutic and reagent antibodies.
1. Purify and formulate recombinant protein antigens and antibodies as deliverables for immunization campaigns, screening assays and in vivo studies.
2. Conduct antibody preparation and determination of antibody affinity and kinetics for targets as a means to choose an optimal therapeutic.
3. Develop and execute the characterization of proteins using SPR, MALS, DLS, DSF, ELISA, SDS-PAGE and other biophysical/biochemical techniques.
4. Document and present experimental data, conclusions and future directions.
1. BS in Biology, Biochemistry or Engineering with 2+ years of relevant industry experience.
2. Primary techniques in protein expression, purification and characterization are required.
3. Experience with Biacore, MALS, DLS and/or other methods for biophysical characterization a plus.
4. Previous experience with biologics and small molecule analysis would be highly preferred.
5. Hands-on experience in flow cytometry/FACS a plus.
6. Flexibility to learn techniques and accomplish goals outside those stated above.
7. Ability to multitask and meet deadlines in a fast-paced environment.
8. Organized and disciplined record keeping.
9. Excellent personality, problem solving and communication skills.
Cancer Biology - Research Associate
Stemcentrx is looking to hire a Research Associate with experience in tissue processing, cell based assays, and stem cell biology. The candidate must have a strong desire to work in a dynamic team environment, aggressively contribute to the company’s growth and mission, and be a catalyst to enable the development and approval of oncology drugs that significantly improve patient survival. The successful candidate will work as part of a team to facilitate the discovery and validation of cancer stem cell-associated drug targets and participate in the development of preclinical in vivo models. In this role, the candidate will support the Cancer Biology group by taking over common tasks including the processing of human and animal tissue for isolation of cells and for cell based assays.
1. BS and/or biology, genetics, or a related field
2. 2+ years of relevant academic and industry experience or MS in scientific discipline
3. Demonstrated proficiency to work aseptically in tissue culture
4. Experience with antibody or cells based assays and flow cytometry in particular are highly desired
5. Ability to multitask and meet deadlines in a fast-paced environment
6. Highly motivated, organized and disciplined record keeping
7. Exceptional verbal and written communication skills are essential
Process Sciences - Associate Scientist / Scientist I / II (Analytical Development)
As part of a talented and multi-disciplinary team advancing an exciting approach to drug development, we are seeking a highly motivated candidate to join our analytical development group. The primary responsibility of this role is to utilize mass spectrometry-based analytical methods for novel ADC molecules. Additional responsibilities related to Analytical Development of LC-UV and CE-based methods are also expected.
The successful candidate will provide analytical support for RPLC-UV-MS characterization of large molecules using peptide mapping and intact mass analysis methods. The candidate will also be responsible for providing support to organic chemistry group for purity determination, structural elucidation of novel linker drugs and its impurities using LC-UV-MS/MS analysis. The candidate will also be responsible for updating LC-UV and CE assay test procedures when necessary.
The candidate must be highly experienced in troubleshooting LC-MS/MS and LC-UV instrumentation issues and performing routine maintenance. Experience with analysis of proteins and small molecules is required. The ability to work independently, while effectively interacting and communicating with other scientists is also a prerequisite.The opportunity will provide exposure to the candidate on various facets of process development for novel molecules and technologies.
1. Ph.D. in Analytical Chemistry or Biochemistry or a related discipline with 0-3 years of post-doc and/or industry experience
2. Hands-on experience (≥ 5 years) performing mass spectrometry based analysis of small and large molecules including non-covalent complexes (preferred). Structural elucidation of molecules using LC-MS/MS instrumentation and software, preferred.
3. Hands-on experience (≥ 5 years) operating, maintaining and troubleshooting various LC-MS/MS systems and LC-UV systems, including working with ABSciex LC-MS/MS systems.
4. Experience with various MS and chromatography data acquisition and analysis software.
5. Mandatory professional skills include organized and disciplined record keeping, emphasis on attention to detail, excellent communication and technical writing skills, an ability to work effectively with others in a dynamic environment, and the ability to self-motivate, multitask, and meet frequently tight deadlines.
6. This position will require support of other Analytical Development functions such as LC-UV development, as well as development of other CE-based assays as required.
Bioinformatics / IT - Software Developer / Sr. Software Developer
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute to the software development team by building custom full stack web applications for use by Stemcentrx scientists helping them with scientific data and workflow management. The ability to work independently, while effectively interacting and communicating with other team members, is also prerequisite.
1. A computer science or related bachelor’s degree and 3+ years of practical industry experience
2. Technical experience in one or more of Ruby, RoR, Java, Grails
4. Experience with a code management system, preferably Git
5. Ability to multitask and work in a fast-paced environment in Agile like development cycles
6. Motivated to build great software in a biotech environment to help cure cancer
7. Great personality and excellent communication skills
8. Strong track record of achievement and advancement desired
In Vivo Biology - Research Associate
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will help perform in vivo experiments. Duties include, but are not limited to, constructing tumor xenograft models, weekly tumor measurements, administering therapeutic agents through various routes, organizing data, and analyzing results. The successful candidate will be expected to efficiently monitor effects of therapeutic agents on tumor growth, metastasis, survival, and overall animal health. The position may also involve assisting with other tasks in the vivarium and/or participate in other exciting areas of research when time permits.
1. Minimum 2-5 years of directly related experience. AALAS certification is preferred but not required
2. Ability to multitask and meet deadlines in a fast-paced environment
3. Organized and disciplined about record keeping, with proficiency in Microsoft Office
4. Able to perform occasional physical labor involving lifting weight up to 50 pounds
5. Willing to split weekend and holiday hours with peers on a rotational basis
6. Excellent verbal and written communication skills
7. Strong organizational skills, motivated to excel, attentive to detail, and can be efficient working alone or in a group environment
Assay Development (BioAnalytical GLP) - Research Associate / Senior Research Associate
Stem CentRx is embracing new paradigms and technologies to develop novel and life-changing therapies for cancer. As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful applicant will be involved in designing, executing and analyzing experiments to evaluate the behavior of novel drug candidates in vivo in a regulated setting. The position requires excellent laboratory skills, critical thinking, and attention to detail at the bench and the desk. The position reports to the BioAnalytical GLP Operations group within Assay Development.
1. Validation of ligand-binding assays for PK and immunogenicity analysis
2. Development of standard operating procedures
3. Testing in support of non-clinical and clinical PK and immunogenicity analysis
4. Assist in maintaining testing lab in a compliant state
5. Receipt, tracking, and reconciliation of samples
6. Perform other related duties as required
1. Bachelors degree in a scientific discipline with a minimum of 3 years’ experience or,
2. Masters degree in a scientific discipline
3. Demonstrated experience developing and performing ligand-binding assays for PK and immunogenicity
4. Prior GLP or GMP experience desirable
5. Experience working with LIMS systems
6. Strong attention to detail
7. Ability to work independently with minimal supervision
8. Ability to analyze data and document results
9. Ability to adapt to changing priorities
10. Strong communication skills (verbal, written, interpersonal, listening)
11. Strong mathematical skills
12. Time management (schedules, timelines, task prioritization)
13. Excellent problem-solving skills; solution-oriented
14. Team oriented
Experience with any of the following techniques is a plus:
1. Study sample management
2. Instrument qualification
GMP Manufacturing - Technical Specialist II / III
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, development and manufacturing, the successful candidate will be part of a small GMP Manufacturing team working to execute GMP production runs to supply the company’s clinical pipeline. Other responsibilities include meeting with vendors to negotiate and procure equipment, participating in Factory and Site Acceptance Tests, leading and supporting IQ/OQ activities for facility and process equipment, creating SOPs and Batch records, establishing operational policies and procedures, and many other activities to ensure a successful production campaign.
1. Perform GMP operations in Seed Lab, Cell Culture, Purification, Conjugation, Formulation, and Filling
2. Support clinical depot function including packaging and shipping of clinical vials
3. Work as part of a small team to execute GMP runs in close collaboration with Process Sciences
4. Transfer process from lab-scale to GMP-scale in support of Tox and early stage clinical studies
1. Inventory management
2. Media and buffer preparation
3. Equipment setup and maintenance
4. Automated skid recipe generation and data management
5. Gain understanding of Cell Culture and Purification theories and principles
6. Successfully troubleshoot processing and equipment issues
7. Train new technicians
1. BS in Life Sciences with a minimum 5 years relevant job experience
2. Experience in GMP operations and working with large-scale manufacturing equipment preferred
3. High degree of self-motivation is required
4. Ability to work under pressure and against tight timelines is required
5. Familiarity with lab techniques and procedures
6. Ability to work as part of a team and work independently with minimal supervision
7. Must have excellent interpersonal and communication skills
8. Strong commitment to working safely
9. Ability to work off-shift and long hours as required
10. Mechanical aptitude, computer systems, and protein purification skills preferred
11. Ability to lift 30 lbs is required
GMP Manufacturing - Technical Writer / GMP Documentation Specialist
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, development and manufacturing, the successful candidate will assume a number of responsibilities related to management of GMP documentation for production of Antibody Drug Conjugates (ADCs). This position requires close collaboration with Process Sciences, Quality Control (QC), and Quality Assurance (QA) groups.
1. Creation and revision of GMP documentation including Production Batch Records, Standard Operating Procedures, Materials Specifications and Equipment Qualification protocols/reports.
2. Coordination of timelines, document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure timely campaign start dates and to facilitate overlapping campaigns.
3. Driving the continual improvement of GMP Batch Records and SOPs from campaign to campaign by soliciting and incorporating feedback from GMP, Process Sciences and Quality groups.
4. Review of completed batch records and other GMP documents in collaboration with Quality Assurance as needed to ensure accuracy and completion in accordance with cGMP regulations.
5. Development and coordination of training sessions for new and existing SOPs and Batch Records in collaboration with Process Sciences and Quality groups.
1. BS in Biological Sciences, Chemistry, Chemical Engineering or related discipline and 10+ years of experience in a GMP environment or 5 years of relevant GMP documentation experience.
2. Proficiency in standard word processing software and project management software is required.
3. Mandatory professional skills including knowledge of cGMPs for biopharmaceuticals, organized and disciplined record keeping, excellent communication skills, an ability to work effectively with others in a dynamic environment, and the ability to self-motivate, multitask, and meet tight deadlines.
4. Knowledge of biopharmaceutical unit operations for production of monoclonal antibodies is preferred.
Quality - Quality Assurance Director
A hands-on position responsible for performing a wide variety of quality activities with emphasis managing a phase-appropriate quality system and QA operations in support of internal GXP activities and at contract service providers. Responsible for ensuring regulatory compliance at Stemcentrx. Provide leadership for establishing and enhancing, in a phase-appropriate manner, the quality and compliance culture at Stemcentrx.
1. Manage the quality system to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives
2. Ensure that required Standard Operating Procedures are implemented to support a phase-appropriate approach to the GXP activities
3. Implement a risk-based approached to support the GMP operations (risk management)
4. Provide Quality review of batch records, analytical data, certificates of analysis, and other documents as needed for consistency with applicable regulations and for compliance with company’s GMP Quality System
5. Assess deviations, OOS investigations, and manage timely investigations and CAPAs
6. Provide Quality oversight of the change control processes
7. Provide Quality support to the GMP manufacturing operations and facility
8. Monitor and analyze quality trends, identify continual improvement opportunities and conduct training as needed
9. Report to management quality issues and trends
10. Lead GXP audits of internal functions or external contract providers including vendor qualification
11. Develop a GMP training curriculum based on the SOPs and GMP regulations that compose the company GMP Quality System. Training includes initiation of new employees, training necessary for any expansion of current operations, and training necessary for on-going improvements in company’s GMP Quality System
12. Represent quality in project teams
13. Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters are addressed in an open and timely manner
1. B.S. or advanced degree in chemistry, biology or related science with minimum 8 years’ experience in the pharmaceutical / biopharmaceutical industry and 5 years direct experience managing Quality
2. Strong working knowledge and interpretation/implementation of cGMP and GLP regulations, familiarity with worldwide regulatory guidelines, and experience dealing with regulatory authority inspections is a plus
3. Proven management skills with ability to lead others effectively and experience to advocate a quality environment
4. Ability to work effectively with various technical groups and a strong working knowledge in one or more of the following disciplines: API or drug product manufacturing, pharmaceutical sciences, analytical development / QC labs, GLP requirements.
Quality - Quality Control Associate
As part of a talented, dynamic and fast-paced team, the successful applicant will support various aspects of QC testing for antibody drug conjugates. This opportunity will involve HPLC, CE, GC, KF and other analytical methods for lot release, raw materials and stability testing in a cGMP environment. This position requires excellent laboratory skills and great attention to detail at the bench and with documentation. There is opportunity to grow and own projects or processes in areas of analytical method qualification, raw materials, equipment qualifications, etc.
1. Lead method qualification and transfer activities from the Analytical Development group to QC.
2. Perform testing for lot release, raw materials and stability in support of cGMP activities.
3. Share responsibilities with the team to support sample and equipment management, and assist in maintaining the QC lab and its systems in a cGMP compliant state.
1. Bachelor’s degree in a scientific discipline.
2. Demonstrated expertise in analytical techniques like HPLC, GC, KF, iCIEF, CE, etc.
3. 2+ years of experience working in a cGMP compliant environment.
4. Ability to multi-task, effectively manage timelines, great attention to detail and team-oriented personality are a must.
Clinical Pharmacology - Sr. Toxicologist / Prinicipal Toxicologist
We are seeking a world-class toxicologist to be a part of a talented and multi-disciplinary team that will advance novel therapies and approaches to eradicate cancer. The successful candidate will have strong leadership skills and an excellent understanding of the scientific drivers and designs of nonclinical safety studies.
Advance and leverage the safety assessment of antibody-based therapeutics through in vitro, in vivo, and in silico methods:
1. Develop novel platforms to interrogate the toxicity of therapeutic candidates
2. Generate and/or integrate data across multiple studies to generate and test novel hypotheses
3. Conduct/outsource pharmacology and toxicology studies
4. Summarize key findings in reports and presentations
Advance the therapeutic pipeline:
1. Lead/design internal studies to define the safety profile of a drug candidate
2. Monitor outsourced studies
3. Contribute to the development of regulated documents, such as INDs and BLAs
4. Contribute to the efforts for target validation and lead drug identification
1. An advanced degree (PhD, DVM) in pharmacology, pharmaceutical science, or other related fields
2. 2+ years of relevant experience
3. Strong pharmacology and toxicology background
4. Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
Responsible for the accounting operations of the company, to include the production of periodic financial reports and maintenance of an adequate system of accounting records and a comprehensive set of controls and budgets designed to (i) mitigate risk, (ii) enhance the accuracy of the company's reported financial results, and (iii) ensure that reported results comply with generally accepted accounting principles.
1. Oversee the operations of the accounting department, including the design of an organizational structure adequate for achieving the department's goals and objectives
2. Implement a documented system of accounting policies and procedures in accordance with best practices
3. Oversee the implementation of new financial information system(s)
4. Oversee the proper and timely processing of transactions (procurement, cash disbursements/accounts payable, revenue recognition, cash collections/accounts receivable, bank reconciliations, payroll, stock administration), and implement and maintain a system of controls over accounting transactions
5. Maintain the chart of accounts and implement and maintain an orderly accounting filing system
6. Issue timely and complete financial statements
7. Calculate and issue financial and operating metrics (including recommending benchmarks for comparison), and manage the production of the annual budget and forecasts, along with monthly reports on variances from budget and explanations therefore
8. Provide financial analysis as needed
9. Coordinate the provision of information to external auditors for the annual audit
10. Comply with local, state, and federal government reporting requirements and tax filings
11. Supervise finance liaison to clinical operations
12. Research accounting literature and apply technical standards to complex business issues and transactions, including the areas of revenue recognition, cost of revenue, clinical and R&D accruals, stock compensation, and tax
13. Along with CFO, identify need for, and make, additional hires in accounting organization as necessary to support growth of the company
14. Along with CFO, implement best practices for cash management
15. Implement accounting controls and procedures for subsidiaries and international operations, as applicable
The controller candidate should have a Bachelor's degree in accounting or business administration, or equivalent business experience and 10+ years of progressively responsible experience for a major company or division of a large corporation. Preference will be given to candidates with the Certified Public Accountant or Certified Management Accountant designations. Must be highly motivated, a strong team player and able to thrive in the environment of an emerging growth company.
Clinical Data Management - Senior Clinical Data Manager
As a Senior Clinical Data Manager you will be able to work independently and be accountable to set the priorities and ensure all data management procedures are executed with high attention to detail, accuracy and timeliness. The Senior Clinical Data Manager will work on multi-functional teams and will support CDM through experience and knowledge as a departmental subject matter expert. They will maintain program/project level perspective, focus and communicate effectively as the SME on data management issues, activities, and deliverables.
1. Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements
2. Create, review, and maintain project timelines and monitor progress of data management activities
3. Assist in the preparation and review of specifications for designing, monitoring and transferring of electronic databases
4. Be a strong technical resource relative to CDM and CDM supportive tools, programming and reporting environments
5. Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedure
6. Perform user acceptance testing on database applications and data transfers
7. Create required study documentation (i.e. DMP, DQS, data entry instructions and CRF Completion Guidelines)
8. Review and approve CRF design, data review and database design guidelines according to Standard Operating Procedures and protocol specific requirements
9. Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity and accuracy based on project specific guidelines
10. Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
11. Generate and review reports and listings to maintain data integrity and reporting
12. Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers
13. Act as clinical data management liaison/lead to communicate study status, timeline updates, scope change with internal project management and departmental leadership
14. Manage and/or liaise with 3rd party vendors specifically related to data collection, review and analysis, and communicate project timelines
15. Perform external data reconciliation; assist in developing/designing reports and computer programs to assist in the data review process and provide operational metrics
16. Develop strong working relationships and maintain effective communication with Clinical Operations, Safety Regulatory, Biostatistics, Programming, and Quality Assurance
17. Assist in developing data management process and procedure improvements
1. Bachelor’s Degree in Life Science, Nursing, Computer Science or related disciplines or equivalent combination of experience and education
2. 8+ years of experience in CDM, of which 3+ years in either a leadership role as a Team Leader/Manager for a significant clinical program, or a supervisorial role within a CDM function
3. Proficiency in the development and use of commercial clinical data management systems/EDC products (e.g. RAVE, Inform, TrialMaster, Oracle Clinical/RDC, etc.)
4. Extensive clinical data management experience in Pharmaceutical or CRO setting Comprehension of medical terminology desirable
5. Experience using SAS
6. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle)
7. Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Chemistry - Research Associate
As part of a talented and multi-disciplinary team advancing an exciting new approach to oncology drug discovery and development, the successful candidate will participate in discovery synthetic chemistry efforts aimed at identifying and developing novel linkers, payloads and linker-drugs technologies for preclinical evaluation and clinical use. The successful candidate will have strong synthetic skills, outstanding attention to detail and excellent record keeping abilities.
1. Synthesize, purify and characterize biologically-active organic small molecules and linkers
2. Contribute to optimization and validation of synthetic routes applicable for cGMP manufacturing of linker-drugs on multigram scale
3. Maintain excellent experimental records for research and development efforts
4. Contribute to development and optimization of analytical characterization methods for linker-drugs.
1. BSc in Synthetic Organic Chemistry 2+ years of laboratory experience
2. Experience in multistep organic synthesis
3. Strong small molecule purification skills
4. Knowledge of common spectroscopic and analytical techniques (NMR, MS, HPLC)
5. Highly organized and disciplined record keeping
6. Strong verbal and written communication skills are essential
7. Excellent laboratory practices and safety techniques are essential
8. Ability to multitask and meet deadlines in a fast-paced environment
Chemistry - Senior Research Associate
As part of a talented and multi-disciplinary team advancing an exciting new approach to oncology drug discovery and development, the successful candidate will participate in discovery synthetic chemistry efforts aimed at identifying and developing novel linkers, payloads and linker-drugs technologies for preclinical evaluation and clinical use. The successful candidate will have strong synthetic skills, outstanding attention to detail and excellent record keeping abilities. Experience in cGMP manufacturing is required to be considered for this position.
1. contribute to optimization and validation of synthetic routes applicable for cGMP manufacturing of linker-drugs on multigram scale
2. maintain excellent experimental records for research and development efforts and actively participate in translating those into GMP batch records and supporting documentation
3. contribute to the GMP manufacturing related operations, maintenance of the inventory, coordination of raw materials ordering and waste management
4. synthesize, purify and characterize complex biologically-active organic small molecules and linker-drugs
5. contribute to development and optimization of analytical characterization methods for linker-drugs
1. BSc in Synthetic Organic Chemistry 3+ years of experience
2. Experience with cGMP manufacturing and documentation
3. Experience in multistep organic synthesis
4. Strong small molecule purification skills
5. Knowledge of common spectroscopic and analytical techniques (NMR, MS, HPLC)
6. Highly organized and disciplined record keeping
7. Exceptional verbal and written communication skills are essential
8. Excellent laboratory practices and safety techniques are essential
9. Ability to multitask and meet deadlines in a fast-paced environment
Molecular Pathology & Diagnostics - Scientist
As part of a talented, multi-disciplinary, and passionate team advancing an exciting new approach to drug discovery and development, we are looking to hire a highly motivated candidate to join our molecular pathology and diagnostics group.
The ideal candidate will have substantial experience with slide-based assays on FFPE tissues such as immunohistochemistry and in-situ hybridization in multiple formats (chromagen and fluorescence). The ideal candidate will have experience in slide based assay development for clinical biomarker or companion diagnostic assay development. Advanced knowledge of human solid tumors, normal human primate tissue and xenograft tumor model histology is a must. Ability to independently design and execute complex experiments, analyze and present data is also a must.
1. Perform immunohistochemistry and in situ hybridization experiments to help validate target expression on human tumors, xenograft lines and normal tissues to advance Stemcentrx’ pipeline of targets
2. Develop scoring algorithms to quantitate target expression and assist in correlating IHC and ISH data to other assay metrics and/or patient response
3. Perform advanced image analysis using commercial software packages
4. Develop IHC and ISH protocols as multiplexed assays to advance the scientific development of the company
5. Collaborate with external companion diagnostics companies
6. Contribute to the development and optimization of analytical characterization methods for linker drugs.
1. Bachelor’s degree in a relevant scientific field with a minimum of 8 years industry experience, or a Ph. D with a minimum of 4 years’ industry experience
2. The candidate must be able to proactively communicate across functional teams and stay abreast of current trends in pathology so as to evaluate and implement new processes and efficiencies
Quality Assurance - Document Control Specialist
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute to Quality Assurance, in Document Control group.
1. Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving.
2. Coordinates the revision, review, and approval of SOPs and other GMP documents.
3. Responsible for SOP biennial update.
4. Organizes and ensures accurate and reliable filing systems for all paper-based GMP documents.
5. Selects, evaluates, and implements electronic document processing and archiving systems.
6. Ensure and maintain up-to-date manufacturing and testing documentation for Stemcentrx products.
1. BS Degree in scientific discipline.
2. Quality professional with 2+ years of hands on experience with document control process in pharmaceutical industry.
3. Requires excellent word processing, formatting, merging of PDF’s from MS Word
4. Well-organized and detailed oriented professional, with strong verbal and written communication skills.
5. Good computer skills with working knowledge of MS office such as Word and Excel, Access and Adobe Acrobat professional.
6. Well-organized and detailed oriented professional, with strong verbal and written communication skills.
Biomarker / CDx Discovery & Development - Senior Scientist / Director
As part of a talented and multi-disciplinary team advancing an exciting new approach to oncology drug discovery and development, we are seeking a creative and highly motivated companion diagnostics (CDx) expert to identify, develop and implement strategies that enable and support the discovery, development and commercialization of the company’s therapeutic oncology programs. The successful candidate will have the opportunity to work in a highly collaborative environment and will participate as a key member of multidisciplinary discovery and development project teams comprising both internal teams and external collaborators and CROs. Candidate will also have a strong desire to work in a dynamic team environment and aggressively contribute to the company’s growth and mission. He or she will also have a demonstrated ability to work with a high level of initiative and be able to work independently with minimal supervision.
1. Have in depth experience with the discovery, characterization, clinical validation and utilization of both conventional and innovative biomarkers and CDx, with direct experience in the development, sourcing and validation of clinically applicable assays
2. Have good familiarity with biomarker and CDx regulatory guidance documents; experience interacting with the FDA is a plus
3. Provide expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarkers and/or diagnostics
4. Coordinate and direct the development, sourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
5. Design, implement and oversee clinical biomarker and diagnostic testing and data analysis
1. PhD or MD/PhD with 5+ years of relevant academic and industry experience
2. Demonstrated excellence and productivity in independent, related R&D efforts
3. Demonstrated ability to evaluate, interpret and present complex scientific data
4. Experience with clinical translational research and awareness of the challenges of implementing biomarker and CDx technologies in the clinical setting; FDA interaction experience is a plus
5. Motivated, organized and disciplined record keeping
6. Exceptional verbal and written communication skills are essential
7. Ability to multitask and meet deadlines in a fast-paced environment
Clinical Operations - Senior Clinical Research Associate
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, we are seeking a Senior Clinical Research Associate to be involved in early phase clinical trial operations.
1. Manage and lead the day-to-day operations of early phase studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
2. Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities
3. Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
4. Supervise site monitors
5. Conduct study monitoring visits and co-monitoring visits as needed
6. Provide regular updates of study progression to Clinical Operations Head
7. Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
8. Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team as applicable
9. Lead feasibility assessment and selection of sites
10. Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
11. Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)
12. Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
13. Provide oversight and direction to study team members, including vendors, for study deliverables
14. Coordinate with finance to track the financial status against budget
1. BA/BS or RN degree with at least 5 years clinical trial experience (oncology preferred)
2. Must have strong knowledge of ICH/GCP guidelines
3. Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
4. Strong experience in management of CROs and other vendors
5. Requires proven project management skills and study leadership ability
6. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
7. Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
Clinical Operations - Clinical Scientist
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute the success of our oncology programs.
1. Responsible for supporting the design, execution, analysis, interpretation and presentation of clinical studies in oncology.
2. Supports and may participate in the development and execution of strategies for new product development and lifecycle growth, including regulatory and investigator interactions as applicable.
3. Provides medical strategic input for oncology clinical and translational projects
4. Supports the planning, organization, and direction of the activities of oncology and related clinical trials, including development of clinical protocols and amendments, investigator brochures, and clinical study reports
5. Participates in medical monitoring support, including evaluation of safety, pharmacology and efficacy of ongoing and completed studies
6. Assists with the establishment and implementation of exploratory pharmacodynamic, diagnostic, and biomarker plans in conjunction with partners in clinical pharmacology and diagnostics/biomarkers
7. May interact with external thought leaders, including advisory boards, to support clinical and translational development
8. May prepare or participate in literature reviews and publications as appropriate
1. At least 2 years of medical/clinical scientist experience and/or MD or MD/PhD with experience or specialization in oncology.
2. At least 5 years clinical research experience is preferred, particularly in drug development.
3. Ability to communicate efficiently with preclinical, biomarker, biostatistical and computational scientists, as well as clinical and commercial colleagues who may be outsourced and/or remote. Ability to explain medical and scientific technical issues to technical and non-technical staff
Clinical Operations - Senior Statistical Programmer
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute the success of our oncology programs. The candidate will provide programming support for multiple oncology studies in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medical Writing, Clinical Information Systems, Clinical Operations, Drug Safety, Regulatory and Medical to design, write, and validate SAS® programs in accordance with company, industry, and regulatory requirements.
1. Develop and validate SAS® programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include datasets, tables, listings and figures.
2. Review and provide feedback on deliverables from other clinical groups including but not limited to: statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms.
3. Clear and proactive communication with Study / Project teams to clarify requirements and specifications, update others on assignment status, and to convey data irregularities.
4. Provide active support on planned initiatives that facilitate infrastructure and process enhancements within Biometrics.
1. BS or equivalent relevant education and 3+ years or MS/PhD and 2+ years of software development and/or programming experience; years of experience may substitute for education.
2. 1+ years of programming experience using SAS®.
3. Experience with additional programming languages and tools such as S-Plus, R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS.
4. Experience with oncology clinical studies, including outsourced studies
5. Experience implementing CDISC standards.
6. Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area.
7. Good written and verbal communication skills.
Clinical Operations - Senior Medical Writer / Director Medical Writing
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute the success of our oncology programs. The candidate will manage, write and edit clinical and regulatory documents, communications and publications for Stemcentrx programs.
1. Manage medical writing activities in Stemcentrx programs. Director may manage contractors and/or other staff writers
2. Write, edit and facilitate the review of clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents, including the development and management of timelines, as well as publications such as abstracts, posters, Powerpoint presentations, manuscripts.
3. Responsible for clinical trial registration and results disclosure in compliance with US and EU requirements.
4. May oversee clinical library / information systems
5. May develop standards and processes for clinical document production
1. Bachelor’s degree in a life sciences discipline (advanced degree preferred) and a minimum of 2 years biopharmaceutical industry experience.
2. Experience preparing clinical regulatory documents and scientific publications. Prior regulatory submission experience preferred, including eCTD standards.
3. In-depth understanding of regulatory/ICH guidelines and GCPs, Good Publication Practices (GPP) and related standards (e.g. CONSORT, ICMJE), and clinical trial transparency requirements (e.g. EudraCT, CT.gov)
4. Expert abilities in Microsoft Office Suite, Adobe Acrobat, and electronic content management systems.
5. Strong written and verbal communication skills
6. Experience in oncology drug development. Successful experience in managing teams and mentoring staff preferred.
7. Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment.
Clinical Operations - Medical Director / Senior Medical Director
As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery and development, the successful candidate will be expected to contribute the success of our oncology programs.
1. Responsible for the design, execution, analysis, interpretation and presentation of clinical and translational studies in oncology, particularly solid tumor malignancies.
2. Participates in the development and execution of strategies for new product development and lifecycle growth, including regulatory and investigator interactions as applicable.
3. Provides medical strategic leadership for oncology clinical and translational projects
4. Plans, organizes, and directs the activities of oncology and related clinical trials, including development of clinical protocols and amendments, investigator brochures, and clinical study reports
5. Provides medical monitoring support, including evaluation of safety, pharmacology and efficacy of ongoing and completed studies
6. Establishes and implements exploratory pharmacodynamic, diagnostic, and biomarker plans in conjunction with partners in clinical pharmacology and diagnostics/biomarkers
7. Interacts with external thought leaders, including advisory boards, to support clinical and translational development
8. Prepares literature reviews and publications as appropriate
1. MD or MD/PhD in an oncology. Board certification is preferred.
2. Clinical drug development experience in oncology, preferably in solid tumors such as lung or ovarian cancers.
3. Experience with and strong understanding of translational disease biology and translational medicine in oncology. Experience and/or interest in antibody-drug conjugates would be preferred.
4. Excellent professional reputation and working relationships
5. Working experience in the pharmaceutical industry preferred.
6. Ability to communicate efficiently with preclinical, biomarker, biostatistical and computational scientists, as well as clinical and commercial colleagues, who may be outsourced and/or remote. Ability to explain medical and scientific technical issues to technical and non-technical staff
CV / Resume
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Current Open Positions:
Assay Development (BioAnalytical GLP)
Research Associate / Senior Research Associate
Bioinformatics / IT
Software Developer / Senior Software Developer
Biomarker / CDx Discovery & Development
Senior Scientist / Director
Clinical Data Management
Senior Clinical Data Manager
Sr Manager / Associate Director
In Vivo Biology
Molecular Pathology & Diagnostics
Associate Scientist / Scientist I / II