Director, Clinical Operations, Retina
- Employer
- 4D Molecular Therapeutics
- Location
- Emeryville, CA
- Start date
- Jan 8, 2022
View more
- Discipline
- Clinical, Clinical Research, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
GENERAL SUMMARY:
The 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 or Sr. Director of Clinical Operations 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 assigned clinical programs including hiring, training, mentoring, and retaining staff
- 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 for assigned programs
- Collaborate with Finance on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; overseeing clinical vendor outsourcing strategy within their assigned program(s);
- 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
- Develop and present program or departmental initiatives and/or activities to Clinical Development leadership and/or Executive Team
- Support development of and identify Clinical SOPs and work instructions to ensure consistency across 4DMT trials and SETs
- Ensure program adherence to SOPs, work instructions, and other governance documents, including timely training
- Partner closely with Quality to ensure that their assigned programs 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) for assigned program(s)
- 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.
Qualifications:
- BS/BA in Life Science or related discipline required
- Advanced degree (MS, MPH, MHS, Ph.D., MBA) preferred
- Clinical Research certification is preferred, but not required Experience:
- A minimum of 8 years of applicable industry experience in drug development (Clinical Operations) across both early (Phase 1 or 2) and/or late-stage (Phase 3), 3-4 years in a leadership role.
- a minimum of 3-5 years of direct line management experience. Skills:
- Proven ability to recruit, retain, organize, and motivate clinical operations personnel
- Proven leadership of maintaining and building a best in class the Clinical Operations organizations
- Ability to communicate to the 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 a 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, including proof of current vaccination status to work on-site
- 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
About 4DMT:
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 on 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.
Attention: Search Firms / 3rd Party Recruitment Agencies*
The Talent Acquisition / HR team manages the recruiting for all positions at 4D Molecular Therapeutics. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to 4D Molecular Therapeutics will be considered property of 4D Molecular Therapeutics. 4D Molecular Therapeutics will not be responsible for any fees associated should we hire from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions. Recruiters interested in working with 4D Molecular Therapeutics can submit their information to recruiting@4dmt.com– should we have a tough-to-fill role, we will contact you directly if you specialize in that area.
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
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert