VP, Clinical Safety and Pharmacovigilance

VP, Clinical Safety and Pharmacovigilance

Job Description

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients withcal complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company’s pipeline is based on its platform technology addressing a broad spectrum of well-researchedcal complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of thecal complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entirecal complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio.

Desired Candidate Profile

Reporting into the SVP, Translational Medicine, the Vice President, Clinical Safety and Pharmacovigilance will be responsible for overseeing and directing Annexon’s portfolio of investigational compounds; building the department function and actively participating in the oversight of patient safety in all clinical trials. The successful candidate will be responsible for executing short-term objectives while developing a long-term vision and strategy for monitoring and protecting the safety of patients receiving Annexon’s novel therapies.

Specific Responsibilities

·       Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Annexon standards.

·       Collaborate with members of the clinical development team in the development and implementation of clinical protocols, safety management plans, data monitoring committee charters, informed consent form (ICF) risk template language, and safety events adjudication.

·       Manages internal employees, external contractors and vendors to ensure delivery of quality drug safety and PV activities; selects, develops, trains and evaluates team to ensure the efficient operation of the drug safety function.

·       Medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.

·       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.

Key Qualifications

·       MD, MBBS, DO degree with clinical post-training is required

·       A minimum of 10 years of relevant drug safety and/or clinical research/clinical safety experience in the biotechnology/pharmaceutical/CRO industry, including safety leadership experience.

·       Thorough understanding of U.S. pharmacovigilance regulations, GCP & ICH guidelines.

·       Ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functions

·       Neurodegenerative disease, ophthalmology and/or autoimmune expertise is a plus.

·       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.

·       Annexon’s VP, Clinical Safety and Pharmacovigilance will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.