Job: 65-21BA; 66-21BA
Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.
We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) to join our fast paced and dedicated Clinical Operations team. This position is accountable for all activities related to the planning, timely execution, and efficient conduct of assigned clinical studies in support of Ambrx’s clinical development programs. The CTM will work independently and in a fast-paced team environment, manage both ongoing and new clinical trials, select vendors and oversee CRO activities, negotiate site budgets and contracts, draft study plans and manuals, review and track monitoring reports, review and approve clinical trial invoices, liaise with CMC, QA, and relevant stakeholders, ensure clinical conducts are in compliance with FDA regulations and ICH/GCP requirements while driving milestones according to established goals and timelines.
Job Requirements and Qualifications:
- Bachelor’s degree in nursing or life sciences or equivalent
- 8+ years experience managing all aspects of clinical trials
- Excellent oral/written communication and organizational skills
- Strong interpersonal skills and highly motivated
- Ability to perform both independently and in a fast-paced and matrixed team environment
- Demonstrated prior success in leading phase 1-3 US and international clinical studies including overseeing CRO(s) and site activities to ensure data integrity, PK samples and study drug reconciliation, and all clinical trials are conducted efficiently and in compliance with FDA regulations, ICH/GCP guidelines, and applicable country specific regulations and guidelines.
- Provide inputs for protocol development and amendments; develop and implement ICFs, clinical study plans, manuals, and forms, such as Monitoring plan(s), Pharmacy Manual(s), CRF Completion Guidelines, Site Management Plans, Protocol Deviation Management Plan(s), Site Initiation Presentation, IRB/EC/REB regulatory packages etc.
- Support preparation of regulatory submission documents Annual Reports, DSUR, IB, CSRs.
- Manage central lab, PK samples and study drug reconciliation, address questions with sites, CRAs, and core lab(s), ensuring compliance with protocol and timely analysis and reporting of PK data.
- Willing/able to travel 20% – 30%, valid, current passport
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to firstname.lastname@example.org. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits.