Associate Director, Clinical Regulatory Affairs

Location
Emeryville, CA
Posted
Mar 31, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining 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 competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
We are seeking an experienced Associate Director, Clinical Regulatory Affairs focusing on the management of 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 pre-clinical and clinical teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of pre-IND, IND, clinical trial applications, and other clinical filings. 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.
Responsibilities
  • Oversee planning, preparation, and submission of the clinical documents (e.g., protocols, investigator brochures, etc.) and pre-clinical sections of INDs and clinical trial applications globally. Ensure that the sections are complete, well-written, and meet all relevant regulatory requirements.
  • Develop excellent relationships with internal functional groups, contract research organizations, and 4DMT partners.
  • Provide regulatory advice to clinical operations and pharmacology/toxicology departments based on knowledge of current regulatory requirements.
  • Manage interactions with FDA or other regulatory authorities for assigned projects.
  • Respond to agency questions and requests for information.

Qualifications
  • BS/MS degree in related discipline required
  • Experience:
  • At least 7 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)
  • Expertise in complex biologics is required. 
  • Experience in gene therapy is highly desirable.
  • Skills:
  • Experience in filing INDs and CTAs for pharmaceutical, gene therapy or biologic products in the US and/or Europe 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 required.
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously.
  • Effective oral and written communication skills.
  • Aid in development of departmental policies and oversees their implementation.   
  • Applies strong analytical and business communication skills.
  • Knowledge of cGCP (FDA, ICH, and ISO) requirements and FDA 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.
  • Outstanding interpersonal and communication (written and verbal) skills
  • Proficiency with Microsoft Word, Outlook, Sharepoint, and Adobe Acrobat
  • Physical Requirements of the Role:
  • Must be able to remain in a stationary position 50% 
  • Adhere to 4DMT COVID protocols and policy 

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