Senior Director, Clinical Operations
- Employer
- 4D Molecular Therapeutics
- Location
- Emeryville, CA
- Start date
- Mar 1, 2021
View more
- Discipline
- Clinical, Clinical Research, Manufacturing & Production, Operations
- 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:
The Senior Director, Clinical Operations supports the VP in leading and managing the Clinical Operations group to design and execute clinical trials per corporate objectives, corporate standard operating procedures (SOPs), and Good Clinical Practice (GCP).
Responsibilities
- Partner with VP, Clinical Operations & Data Management and Chief Medical Officer (CMO) to develop and manage program operational strategies and plans for all products in compliance with corporate objectives and timelines
- Develop resourcing plans and clinical trial timelines across multiple global, dynamic programs
- Participate as Clinical Operations subject matter expert (SME) on annual budgets to support clinical trial activities and required infrastructure
- Participate as an SME for clinical operations related due diligence activities
- Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups
- Additional groups may be added to this role’s responsibility as 4DMT grows
- Collaborate with Finance on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees
- Directly manage and actively partner with Clinical Trial and Program Leads to ensure that clinical trial protocols are executed to meet corporate objectives and in compliance with corporate SOPs and GCP
- Sit on product cross-functional core teams as Clinical Operations SME, as required
- Collaborate with and support the Data Management group to ensure that it develops and adapts to industry best practices and regulatory guidance. Implement business intelligence and analytics tools to improve data-based review and data-driven decision-making
- Develop and present functional and organizational goals and/or activities to Clinical Development leadership and/or Executive Team
- Define functional staff resourcing needs, including hiring, training, mentoring, and retaining staff
- Define and develop implementation plans for internal, scalable infrastructure and systems to ensure compliance, efficiency, and high performance
- Identify, develop and/or author SOPs and work instructions to ensure consistency across 4DMT trials and SETs
- Work with VP Clinical Operations to ensure that the appropriate SOPs are being developed as needed
- Ensure departmental adherence to SOPs, work instructions, and other governance documents, including timely training
- Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready
- Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov)
- Partner with other group and/or functional leaders across 4DMT to identify and to implement best practices to ensure that 4DMT meets corporate objectives and adapts to changing business needs
- Actively support and foster cross-functional communication.
- Other duties as assigned
Qualifications
- BS/BA in Life Science or related discipline required
- Advance degree (MS, MPH, MHS, Ph.D., MBA) preferred
- Clinical Research certification preferred, but not required Experience:
- 16+ years of applicable industry experience in drug development across both early (Phase 1 or 2) and late-stage (Phase 3) clinical development
- 12+ years managerial experience Skills:
- Proven ability to recruit, retain, organize, and motivate clinical operations personnel
- Proven leadership of a maintaining and building a best in class the Clinical Operations organizations
- Ability to communicate to leadership team on Clinical Operations and Clinical Data Management updates and priorities as well as to advocate for required budget and resources
- Ability to manage and oversee large scale programs that have corporate-wide impact
- Ability to develop and manage functional and clinical trial-specific budgets
- Must be self-motivating; prioritize and manage a large volume of work; show attention to detail
- Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
- Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
- Ability to be flexible and adaptable to changing business needs
- Relevant experience in clinical trial execution across all phases.
- Excellent communication and interpersonal skills
- Must be able to write clearly and summarize information effectively
- Must be able to present complex information to various audiences Physical Requirements:
- Adhere to 4DMT COVID protocols and policy
- Until it is deemed safe to return to our Emeryville worksite, this role will be remotely based.
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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