Director, Drug Safety/Pharmacovigilance

Location
Emeryville, CA
Posted
May 26, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.  

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.  

GENERAL SUMMARY:  
Reporting to the Chief Medical Officer , the Director of Safety/Pharmacovigilance is responsible for providing oversight and day to day management of all activities pertaining to product safety and pharmacovigilance in clinical development and post-marketing surveillance, The Director of Safety/Pharmacovigilance ensures that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for 4DMT products. 
Responsibilities:
  • Advance and maintain the safety governance oversight for all company Therapeutics products. 
  • Collect, synthesize and deploy relevant drug safety information on all programs within 4DMT models.
  • Responsible for ongoing safety data review and signal detection, management of serious adverse event reporting, aggregate safety reporting, management of risk-benefit profiles, risk management and mitigation plans for all clinical stage programs.
  • Directly oversee PV external resources to ensure high quality case processing and aggregate reporting, as well as ensuring appropriate documentation and governance frameworks are in place.
  • Lead process improvement within pharmacovigilance – including technology assessment and implementation.
  • Collaborate with appropriate clinical operations, clinical development, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including authoring as appropriate and review of documents such as DSUR, IB, clinical study protocols, informed consent forms, DSMB charters, development plans, and INDs/CTAs.
  • Provide safety expertise to other 4DMT therapeutic functions.
  • Represent in audits with health authorities and development partners.
  • Oversee development of training modules and provide training in Pharmacovigilance across the Company.
  • Other duties as assigned.

Qualifications:
  • Experience in ophthalmology a plus
  • Education:
  • Advanced clinical degree is preferred, e.g. MD, PharmD, advanced practice RN
  • Experience:
  • 5+ years' experience in a Pharmacovigilance leadership role within the Pharmaceutical / Biotechnology industry
  • Gene therapy experience and/or rare disease therapeutic required
  • Experience in ophthalmology a plus
  • Previous experience with clinical trials and knowledge of Good Clinical Practices, regulatory requirements for the conduct of clinical trials
  • Previous experience with data safety monitoring board; charter development, data sharing, reporting
  • Skills:
  • Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
  • Ability to work collaboratively with the internal partners and ability to build relationships with clinical sites and outside vendors
  • The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
  • Attention to details, able to proactively identify issues and propose solutions
  • Excellent written and verbal communication skills
  •  Physical Requirements of the Role:
  • Sitting for prolonged periods of time working on a computer
  • Adhere to 4DMT COVID protocols and policy 
  • During the current COVID-19 pandemic, the ability to work remotely until it is safe to return to the worksite and work onsite once 4DMT deems it safe to return. 

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities