Associate Director, Regulatory Affairs

At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

 

GENERAL ROLE DESCRIPTION:

This position focuses on the management of clinical, nonclinical and CMC aspects of domestic

regulatory affairs for a gene therapy product. The role involves working closely with in-house clinical, pre-clinical and CMC teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of INDs, clinical trial applications and other clinical-oriented filings. The candidate will lead interactions with regulatory agencies, provide insight and regulatory strategies. Expertise with gene therapy or biologics is strongly preferred. This position is also responsible for obtaining and interpreting regulations and guidance and providing regulatory advice to clinical and pharmacology/toxicology departments. Strong communication and management skills are required.

PRIMARY RESPONSIBILITIES:

• Establish the long-term strategy for the regulatory team and regulatory activities for the assigned programs, in collaboration with cross-functional teams.
• Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and responses to agency correspondence.
• Oversee planning, preparation, and submission of the regulatory documents (protocols, investigator brochures, CMC and nonclinical sections of INDs, briefing documents, etc) globally. Ensure that the documents are complete, well-written, and meet all relevant requirements.
• Develop excellent relationships with internal functional groups, contract research organizations, and partners.
• Coordinate and lead responses to health authority questions/inquiries as needed to meet project milestones. Manage interactions with FDA or other regulatory authorities for assigned projects.
• Provide regulatory advice to clinical teams, CMC and pharmacology/toxicology departments based on knowledge of current requirements.
• Review local and global regulations and apply interpretative analyses of key regulatory guidance documents as they relate to ongoing projects and submissions.

QUALIFICATIONS:

Education & Experience:

• Sc. degree minimum. Advanced degree a plus.

Experience:

• At least 8+ years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to the development phase of the product lifecycle)
• Experience in filing INDs and CTAs
• Experience with gene therapy or biologic products is preferred.
• Thorough understanding of relevant drug development regulations and guidelines
• Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs

 

Skills:

• Ability to develop timelines, plan regulatory submissions and work with cross-functional teams to develop content.
• Ability to prepare and submit regulatory documents with strong attention to detail
• Ability to multi-task and support more than one project simultaneously
• Highly organized and motivated; strong analytical, organizational, and problem-solving skills
• Strong work ethic, flexibility, and cooperative can-do attitude
• Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches
• Strong communication skills (both written and oral) with demonstrated ability to present ideas, information and data effectively via one on one discussions, team meetings, and external partnership interactions
• Understanding and knowledge of key software programs (including Microsoft Word, Adobe PDF).

Base salary compensation range:

 

Minimum: 

Maximum: 

Bay Area Range: 

$175,000/year 

$205,000/year 

 

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

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