Head Of Regulatory Affairs
Tenaya Therapeutics, Inc.
South San Francisco , CA 94080
Posted 6 days ago
Tenaya Therapeutics is a preclinical-stage, Series A, privately-held biopharmaceutical company backed by The Column Group. The Company was founded in 2016 by leading scientists from the Gladstone Institutes Cardiovascular Division and the University of Texas Southwestern Medical Center.
Tenaya is dedicated to addressing heart failure through multipronged efforts that target the fundamental cellular pathologies present in diseased cardiac muscle and that leverage cutting-edge research in cardiac development and regeneration.
Tenaya has a lead gene therapy program focused on in vivo reprogramming of cardiac fibroblasts to cardiomyocytes to regenerate heart tissue, and additional programs focused on cardiomyopathies.
Tenaya Therapeutics currently has 25+ full time employees (not including consultants) and is headquartered in South San Francisco, California, USA.
We are looking for a Global Head of Regulatory Affairs to join our team and contribute to bringing our lead gene therapy program to the clinic. In addition to gene therapy, experience in small molecule and biologic development would be relevant across our discovery portfolio. This position will initially report to the CEO but eventually will be reporting to a CMO. This position will be a part of the Tenaya Management Team.
- Bring the Regulatory Affairs functional perspective to the table as the company makes important early decisions about nominating development candidates and building a diverse pipeline of programs and indications
- Identify and recommend strategies for successfully and efficiently achieving product approvals in G7 geographies, including exploration of expedited paths
- Making the case for strategic decisions to the Management Team, Board, and other advisory groups, including related to product development, study design, acceleration opportunities, etc.
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
- Recruit a broader team of regulatory professionals as needed over time, and identify and retain consultants where needed
- Act as the global regulatory lead with early, pre-clinical experience to the end of Phase II and represent the regulatory function on related cross-functional program teams. Works with project teams to resolve complex project issues.
- Monitor, analyze, disseminate, and recommend actions based on intelligence on regulatory matters that may affect the company and ongoing development programs
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
- Serve as the primary liaison with regulatory authorities for the specific programs
- Plan, prepare, and review submissions to regulatory authorities including FDA (CBER) EMA (ATMP/CAT), PMDA and other major national regulatory authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
- Coordinate and prepare responses to questions, requests for information from regulatory authorities
- Advanced scientific degree preferred. B.A./B.S. or higher degree(s) in the sciences, or health-related field is the minimum expectation.
- 10 - 15 years of regulatory experience. Experience at large biopharmaceutical companies, innovative biotechnology start-ups, and consulting agencies are all relevant.
- Experience working with innovative therapies e.g. gene therapy or another novel modality, is highly preferred.
- Track record of having engaged thoughtfully, creatively, and collaboratively with regulatory agencies to create a path for a new modality to advance into and through the clinic, especially in areas where official guidance is missing is incomplete.
- Experience engaging with regulatory agencies at different stages and filing relevant submissions
- Early preclinical development consultations through IND/CTA and eventually end of Phase II is a must.
- Recent experience with pre- and post-approval (BLA/MAA) submissions and product lifecycle management is a plus but not as critical
- Global experience is highly preferred, including interactions with FDA, EMA, and national authorities in major EU countries (e.g. UK, France, Germany). Experience interacting with the Japanese PMDA (including via local consultants) is a plus but not required.
- Thorough knowledge of relevant FDA and EMA regulations that are relevant to cGMP manufacturing environments
- Knowledge of and experience working in the cardiovascular field in general and the heart failure field in particular is a plus but not required
Essential Skills, Abilities, and Attitudes
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues to a broad audience.
- High bandwidth for implementing technical, strategic, and operational plans with a proven track record in identifying and resolving critical issues.
- Outstanding communication skills, with the ability to articulate a strategy and build support across at difference levels internally (Program Team, Management Team, Board) and externally (regulatory agencies, consulting agencies)
- Must thrive working in a fast-paced, innovative environment demonstrating flexibility, strategic agility, and creativity.
- Exceptional management skills and commitment to mentorship to foster collaboration, promote internal growth, and inspire high performing teams.
- Excellent interpersonal and negotiation skills with the ability to develop important relationships with key stakeholders.
- Ability to manage conflict and analyze complex issues to develop relevant and pragmatic plans, programs and recommendations.
We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.
We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.
State-of-the-art, built-to-suit office and lab space overlooking the bay. Part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.