Associate Director, Translational Medicine, Project Lead

Location
Emeryville, CA
Posted
Oct 05, 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:
The Translational Medicine group is key to the success in the development of gene therapies for patients at 4DMT. The Project Leader leads the development of one or more preclinical pipeline products within one or more Therapeutic Areas. The role is very broad from indication selection & evaluation, through lead optimization. The role works closely with the Chief Scientific Officer and will interface regularly with the Executive Team, Clinical Operations, Regulatory, CMC. The role needs a motivated, driven, and experienced scientist that can work within a driven cross-functional team in a fast-paced work environment. 
Responsibilities
  • Lead one or more drug development programs from inception through preclinical studies to IND.
  • Contribute to the strategy, assessment and prioritization of the 4DMT product pipeline
  • Work closely with the Therapeutic Area Heads and the Chief Scientific Officer to translate drug candidates into early phase clinical trials.
  • Develop the strategy for individual and therapeutic area product development
  • Design and implement preclinical in vivo and in vitro studies, including IND-enabling studies
  • Select and lead the core project team (initially working groups, then cross-functional team) for each product under development
  • Study design, protocol development and CRO selection for in vivo studies including bioassay development
  • Study design, protocol development for in vitro studies (interfacing with the Product Development, Technology & Innovation, and Biomarker groups)
  • Work closely with the project management office to execute the above studies
  • Lead and drive the preparation of preclinical modules/packages for regulatory submissions such preIND, INTERACT, IND, Orphan Drug Designation, Fast Track & EMA submission
  • Present and interact with senior management, Executive Team and governance groups (e.g. R&D Leadership, Strategic Portfolio Review and Project Review Committees to meet strategic objectives and company goals, identify program risks and develop risk mitigation plans.
  • Build and manage preclinical scientific advisory boards/meetings.
  • Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Qualifications
  • PhD in biological sciences or MD, required.
  • Experience:
  • 5+ years in project leadership or management role in industry required.
  • Strong scientific experience and ability to be part of a scientific team.
  • In vivo / in vitro pharmacology and toxicology experience a major plus
  • Gene therapy experience a plus.
  • Experience in retina, eye, neuroscience a plus
  • Regulatory and health authority experience a plus.
  • Skills:
  • Agility in leading cross-disciplinary scientific and/or drug development teams
  • Ability to build teams and manage direct reports
  • Ability to strategize, problem solve, analyze, critique, assess and present research data
  • Previous experience in cross-functional teams and work in a scientific or clinical setting supporting drug development.
  • Confident and respectful when interacting with all levels of management; stays focused and on-point, and raises problems or challenges in a productive, solution-minded manner.
  • Ability to prioritize programmatic needs, highly adaptable, professional with the ability to deliver successful programs and regulatory documents
  • Strong interpersonal skills and professional demeanor.
  • Physical Requirements
  • Location: Bay Area location preferred with the requirement to be on site for team meetings during the COVID pandemic period
  • Adhere to 4DMT Covid protocols and policy

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