Associate Director, Clinical Regulatory Affairs
- Employer
- 4D Molecular Therapeutics
- Location
- Emeryville, CA
- Start date
- Mar 1, 2021
View more
- Discipline
- Clinical, Clinical Research, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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
Company
4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.
At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.
While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.
At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.
4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients
GUIDING PRINCIPLES
- Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
- Break Boundaries - Question the status quo and innovate beyond conventional approaches
- Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
- Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans
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 generous benefits and provides challenging opportunities for career development.
- Website
- http://www.4dmoleculartherapeutics.com/
- Phone
- 510-505-2680
- Location
-
5858 Horton St. Suite 455
Emeryville
California
94608
United States
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