Clinical Director/Senior Director, Translational Medicine, Therapeutic Area Head
4D Molecular Therapeutics, located in Emeryville, CA is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. 4D is in need of a talented and motivated Associate Director/Director to join our team in supporting our viral drug therapy research efforts as we contribute to the future of gene therapeutics.
This is a key executive position within 4D Molecular Therapeutics (4DMT). Reporting to the Chief Medical Officer, this individual will lead a team of pre-clinical scientists and medical experts bringing innovative gene therapies to patients. This individual will have a high level of passion for 4DMT’s mission and the ability to operate as an effective strategic, as well as tactical, thinker. The individual will also be effective as a hands-on manager and producer of individual work. Candidates should be an MD/PhD or an MD or equivalent in relevant disciplines, with significant experience in clinical research and development. You will lead a cross-functional team developing therapeutic candidates from concept, design, through IND filing and clinical Proof of Concept (POC) studies (Phase 1-2 trials).
- Set, communicate and drive strategy for TR&D for therapeutic products in alignment with the broader organization of 4DMT.
- Prioritize and allocate resources, to meet portfolio needs.
- Lead the decision-making process with other relevant functional group heads regarding indications, targets and products’ progression from concept, design, preclinical development and Phase 1-2 clinical testing.
- Recruit, convene and manage Scientific and/or Clinical Advisory Boards comprising world-class expertise.
- Provide input on scientific strategy from the earliest consideration of new targets through development, including risk, scientific challenges, timing of resource investment and development of go/no go decisions.
- Direct and coordinate the implementation of preclinical study programs for pharmacology studies in support of the lead to candidate optimization process.
- Design, implement and write-up comprehensive series of pharmacology studies to address preclinical exposure, develop pharmacokinetics and pharmacodynamics profiles and generate GLP toxicology and bio-distribution packages suitable for supporting IND filings.
- Design, implement and manage externally facing in vivo studies with CROs and academic centers, including drafting proposals, budget oversight and managing deliverables.
- Provide direct hands-on responsibility for all TR&D interactions as well as grant writing and management with rare disease advocacy groups.
- Participate on project teams and direct activities to ensure regulatory compliance of pre-clinical and clinical research activities.
- Support regulatory affairs in their preparation, review and submission of necessary pre-clinical and clinical regulatory information to regulatory agencies worldwide.
- Define clear human POC study outcome criteria for decision-making on new product candidates.
- Foster strong external clinical collaborations to maintain state-of-the-art clinical approaches.
- Together with the clinical operations and project management functions, contribute to the quality of clinical protocols, study reports, investigator brochures and regulatory submission documents.
- Involvement in all aspects of the design, conduct, monitoring, interpretation, and reporting of clinical trials.
- Contribute senior level expertise to alliance, business development, and due diligence exercises with external entities and licensing meetings, as well as other critical external interfaces such as public health regulatory bodies.
KNOWLEDGE AND SKILLS:
- MD/PhD, MD or equivalent; experience with translational and clinical R&D.
- Prior leadership position/s within the pharmaceutical/biotech industry or academic medical centers, with a significant history of research and relevant clinical experience.
- Reputation for inspiring a culture of continuous improvement, innovation and quality, leading and mentoring at the highest level of achievement.
- Ability to support and impact experts, scientists and project deliveries across functions in research, development and beyond.
- Strong written and oral communication skills, with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings.
- Excellent time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities.
- Self-starter who proactively establishes effective working relationships and builds partnerships with other disciplines.
- Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment.
- Ability to proactively identify challenges, possess strategic foresight and implement appropriate course of action.
We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure severe genetic and rare diseases with high unmet medical need. We seek 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 uniquely generous benefits and provides challenging opportunities for career development.