Associate Director, Regulatory Affairs

Emeryville, CA, United States

Attention recruitment agencies:

All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

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

The Associate Director, Regulatory Affairs at 4DMT, will be focusing on managing CMC, pre-clinical, and clinical regulatory applications (domestic and international) in support of 4DMT's multiple therapeutics in development. The role requires working closely with 4DMT's key stakeholders, cross-functional teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of clinical trial applications, as well as other regulatory filings. Expertise in complex biologics and/or gene therapy is highly desirable. Experience with regulatory interactions and/or submission to PMDA (Japan) or other international regions is preferable. 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.

This role can be in-person, remote, or hybrid.

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 clinical trial applications) globally. Ensure that the sections are complete, well-written, and meet all relevant requirements.

Develop excellent relationships with internal functional groups, contract research organizations, and partners.

Provide regulatory advice to clinical operations, CMC and pharmacology/toxicology departments based on knowledge of current requirements.

Manage interactions with regulatory authorities for assigned projects.

Respond to agency questions and requests for information.

QUALIFICATIONS:

Education:

B.Sc. minimum

Experience:

8 -10 + 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 filing clinical trial applications for pharmaceutical, gene therapy, or biologic products in the US, Europe, or Japan is required.

Thorough understanding of relevant drug development regulations and guidelines

Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs

Knowledge of the drug development process and global regulations and requirements required.

Strong analytical skills, problem-solving ability, and presentation skills are required.

Flexibility and ability to prioritize and manage multiple tasks simultaneously.

Effective oral and written communication skills.

Aid in the development of departmental policies and oversee their implementation.

Strong analytical and business communication skills.

Knowledge of GCPs, GMPs, GLPs (FDA, ICH, and ISO) requirements and other regulatory guidelines

Ability to work independently in a dynamic and changing company environment

Established track record of clinical Regulatory decision-making

Ability to multi-task and support more than one project simultaneously. Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches.

Strong organizational skills.

Skills:

Proficiency with Microsoft Word, Outlook, SharePoint, and Adobe Acrobat

Excellent written and verbal communication skills

Strong organizational skills

Knowledge of GCPs, GLPs and GMPs

Base salary compensation range:

National Range: $160,000 - $191,000

Bay Area Range: $180,000 - $213,000

Please note that the base salary compensation range and actual salary offered to the final candidate depends on various factors: the 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

#J-18808-Ljbffr