Note: The job is a remote job and is open to candidates in USA. 4D Molecular Therapeutics is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Associate Director, Clinical Operations will be responsible for implementation, execution, and oversight of all clinical trials within a clinical program, ensuring that trials are executed on time, within budget, and in compliance with regulations.
Responsibilities
- Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines
- Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans
- Provides guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing
- Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups
- Collaborate with Finance/Business Operations 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
- Ensure that each clinical trial is always inspection ready
- Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET)
- May sit on product cross-functional core teams as Clinical Operations SME
- 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)
- Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans
- Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents
- Supports development and review of protocols/ amendments, study documents and plans, and operational execution
- Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
- Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials
Skills
- B.S./B.A. in Life Science or related discipline
- B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience
- Requires late phase trial experience
- Proven ability to recruit, retain, organize, and motivate clinical operations personnel
- Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources
- Ability to manage and oversee 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
- 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
- Advanced degree (M.S./M.A., MPH, MHS, MBA)
- Clinical Research certification
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