Associate Director, Translational Medicine

Location
Emeryville, CA, United States
Posted
Feb 22, 2021
Ref
1515278923
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
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:

4DMT is in need of a motivated, team-oriented, and experienced Associate Director, Translational Medicine. This individual will lead the preclinical development of one or more gene therapy product candidates.

Responsibilities:

  • Lead one or more drug development programs through preclinical studies to IND filing.
  • Contribute to the 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.
  • Design and implement preclinical in vivo and in vitro studies, including IND-enabling studies:
  • Study design, full protocol development, and CRO vetting and selection for in vivo studies, including bioassay development
  • Study design and protocol development for in vitro studies (interfacing with the Human Cell and Disease Modeling group scientists
  • Work closely with the program management team to execute all IND-enabling studies
  • Lead and drive the preparation of content for regulatory interactions and submissions (e.g. pre-IND and/or INTERACT meetings, IND filing, Orphan Drug Designation requests, EMA submission) as necessary
  • Present to and interact with senior management and Executive Team members to assess progress toward meeting strategic objectives and company goals, identify program risks, and develop risk mitigation plans.
  • Present data and program updates internally and externally to scientific and non-scientific audiences.

 


Qualifications:

 

 

  • PhD in biological sciences required

  • Experience:

  • 3+ years in project leadership or management role (lab science experience will also be considered) with at least 6 years on biotech or pharma industry experience
  • Ability to work in a small company environment
  • Strong scientific experience and ability to be part of a scientific team.
  • Gene therapy experience is preferred.
  • Experience interacting with FDA and/or other regulatory and health authorities is highly desirable
  • Experience in ocular, neurological, or neuromuscular diseases is desirable
  • Experience in leading scientific and/or drug development teams
  • Previous experience in cross-functional teams and work in a scientific or clinical setting supporting drug development.

  • Skills:

  • Ability to analyze, critique, assess and present research data
  • Ability to prioritize programmatic needs in a dynamic work environment
  • Highly adaptable and professional with the ability to deliver successful programs
  • Knowledge of FDA regulatory process and requirements and the ability to prepare regulatory documents for submission to regulatory authorities
  • Strong interpersonal skills and a professional demeanor
  • Strong communication skills with both scientific and non-scientific stakeholders
  • 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.

  • Physical Requirements:

  • 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