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 an opportunity to join a rapidly growing dynamic platform biotechnology company with multiple products in development. The successful candidate will join a team of outstanding pre-clinical and clinical scientists with the opportunity to gain broad experience in cutting-edge gene therapy, from bench-to-bedside.
The Clinical Scientist/Senior Clinical Scientist will play an integral role in facilitating successful and timely initiation and completion of 4DMTs clinical development programs working with members of Translational Medicine, Clinical Operations, Program Management, Clinical Research Organizations (CROs) and Investigators to plan, execute and monitor medical aspects of selected clinical trials. The successful candidate will operate in a highly detailed and organized fashion with the goal of efficiently driving each program through the clinical development process.
- Collaborate with the translational medicine teams on the design and implementation of clinical studies, the review and interpretation of study results, providing deliverables in approved timeframes.
- Analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
- Lead or collaborate in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
- Engage with investigators, KOLs, SABs, as necessary.
- Engage with site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
- Review and interpret scientific knowledge of competitor landscape (molecule / indication).
- Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) including attendance at major scientific conferences.
- Present clinical strategy and data to internal and external audiences (such as investigator meetings).
- Provide support for business development activities, such as due diligence and research collaborations.
- Maintains knowledge of ICH-GCP, external regulations and procedures.
Knowledge & Skills:
- RN, MS, PhD or PharmD, or equivalent. Advanced degree candidates preferred.
- Clinical science experience with 2+ years of drug development with experience in ophthalmology, cardiovascular disease, lung or neuroscience, preferred.
- Expertise in clinical trial design, implementation, regulatory document preparation and statistics.
- Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data.
- Able to manage priorities and competing demands in a growing biotechnology company with a broad pipeline of products.
- Excellent presentation skills for both internal and external audiences.
- Ability to balance independent work and team interaction.
- Well-developed interpersonal skills, and ability to build strong positive relationships.
- Good leadership and management skills to manage internal and external collaborations and work well within cross-disciplinary teams.
- Ability to travel, approximately 10%.
Qualified candidates may submit a resume and cover letter to email@example.com