Biologics, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
If you are passionate about regulatory affairs within drug development and have a background in CMC, then read on. AAV gene therapy is a rapidly growing field and this Associate Director/ Director of Regulatory Affairs CMC, represents an outstanding opportunity reporting directly to the CTO and Head of Regulatory & Quality.
You will have the chance to take your career to the next level by being principal in development of a world-class CMC Regulatory function at 4D Molecular Therapeutics (4DMT), a world-leader in Therapeutic Vector Evolution for adeno-associated virus (AAV) gene therapy vector discovery and product development. You will implement CMC strategy of submissions and manage all interactions with regulatory authorities. Therefore, your knowledge of the drug development process and global regulations, in addition to biologics experience, will be important to your success.
Implement regulatory CMC strategy for early and late stage clinical product candidates to attain rapid regulatory approvals.
Lead and drive CMC content development for submission activities (planning, authoring, reviewing, coordination, submission) for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications, BLAs and MAAs.
Help in building a world-class Regulatory CMC function to meet 4DMT growing pipeline.
Serve as RA CMC liaison with various internal functions (e.g., Manufacturing, R&D, Clinical Development, etc.).
Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including IND CMC updates, Regulatory Authority meetings briefing documents, etc.
Aid in development of regulatory dossier in support of 4DMT products in development for worldwide submissions.
Respond to CMC queries to advance 4DMT clinical programs.
Aid in establishing, managing, and maintaining a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices.
Assure compliance with regulatory standards and guidance documents, including ensuring that CMC-related changes are reported to authorities in accordance with regulatory requirements.
Conduct risk assessments of global CMC regulatory issues.
Maintain and continue to build 4DMT’ excellent reputation with the regulatory authorities.
Indirectly supervise employees through a dotted line structure or via other subordinate managers.
BS/MS degree (PhD highly desirable) in related discipline and 10 years of related experience with at least 5 years at a manager or above role.
Experience and a proven track record of successes in biological drug submissions (e.g., IND, BLA, MAA), is preferred.
Experience with biologics required, with experience in cell/gene therapy drug development highly desirable.
Knowledge of the drug development process and global regulations and requirements required.
Strong oral and written communication skills, with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings and partnership interactions, including presentations.
Strong analytical, problem-solving and organizational skills.
Ability to prioritize and multi-task, supporting more than one project simultaneously. Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches.
Develop departmental policies and oversee and/or authorize their implementation.
Strong knowledge of cGMP (FDA, ICH, and ISO) requirements and FDA regulatory guidelines.
Flexible and able to work independently in a dynamic and changing company environment.
Established track record of Regulatory CMC and Compliance decision-making.
Experience with close collaboration with R&D, Clinical Operations, and Manufacturing/Supply Chain.
Focus on practical, common-sense, creative, and sensible approaches to finding effective solutions.
Ability to travel (10%).
Additional Salary Information: Competitive to SF Bay Area
Internal Number: 01
About 4D Molecular Therapeutics
4D Molecular Therapeutics (4DMT) is a world-leader in Therapeutic Vector Evolution for adeno-associated virus (AAV) gene therapy vector discovery and product development.
While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of 1st & 2nd generation vectors (naturally occurring primitive viral capsids).
4DMT’s next-generation Therapeutic Vector Evolution platform generates targeted, optimized and proprietary AAV vectors that have the potential to overcome the delivery and immunological challenges currently facing the field, ultimately unlocking the full potential of gene therapy. We target patients with severe genetic diseases with high unmet medical need. Our discovery platform has created over 37 unique AAV vector “libraries” comprising over 100 million vectors to deliver genes specifically to any tissue/organ in the body using lower doses, with resistance to pre-existing neutralizing antibodies, and via the optimal clinical route of administration for any given disease. Additionally, our portfolio of custom capsids and intellectual property sets us apart from other companies in the AAV space. We also span... a diversified pipeline and have established solid successful pharma partnerships.
The company’s lead intravitreally-delivered AAV gene therapy asset for choroideremia is expected to enter clinical trials in 2019. 4DMT closed a $90 million Series B Financing this past September with top tier investors, and their highly accomplished leadership team brings you >75 years combined experience.
Our proven team of biotherapeutics developers and innovative gene therapy scientists has highly complementary skill sets. Prior to forming 4DMT, our CEO David Kirn MD and development team members have developed over 10 different therapeutic viral vectors, including translation into the clinic and Phase 1-3 clinical development in over 30 clinical trials. Our scientists led by our CSO David Schaffer PhD were pioneers in the creation of next-generation AAV vectors for gene therapy.
We believe in success through collaboration. 4DMT has entered into multiple corporate alliances.
We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. 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.