The Director, Drug Safety & Pharmacovigilance will provide broad support of activities requiring medical safety input for assigned products. They will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. They will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.
Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code to create Precision Biologics, this includes next generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as novel cytokines to modulate the immune system and long acting therapeutic peptides for metabolic and cardiovascular disease, all designed to have improved pharmacologic properties and novel biological activity.
- Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Ambrx standards.
- Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
- Provide oversight for the safety aspects for clinical studies, including participation at DMC meetings, and development and maintenance of the company core safety information.
- Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, informed consent forms, final study reports, IB/RSI and other documents.
- Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
- Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices
- Assess safety signals and trends and proactively manage any potential safety issues.
- Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
- Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
- Author analysis of similar events (AOSE) and individual case comments for ICSRs.
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
- Maintain knowledge of global regulatory authority regulations including FDA and EMA.
- Formulate response strategies for safety-related health authority and ethics committee requests.
- Represent PV in communications with health authorities such as the FDA.
- Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
- Other duties as assigned.
- MD degree or equivalent with clinical post-training
- A minimum of ~ 3 years of relevant drug safety experience in the biotechnology/pharmaceutical/CRO industry, including safety leadership experience.
- Thorough understanding of U.S. pharmacovigilance regulations, GCP & ICH guidelines.
- Working knowledge of validated drug safety databases ~ ARGUS, MedDRA, etc.
- Extensive knowledge of all types of aggregate safety reports.
- In-depth understanding of the drug development process.
To be considered for this opportunity, please submit your resume/CV referencing the position code to firstname.lastname@example.org. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.