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A leading biopharmaceutical company focusing on mitochondrial therapies is seeking an
Associate Director of Clinical Operations. The Associate Director of Clinical Operations should strive to further this company's mission of helping patients with unmet treatment needs through collaborating with well-recognized institutions, physicians, and scientists to further the development of cutting-edge therapies. Position Title: Associate Director of Clinical Operations Position Summary: We are seeking a detail oriented, problem solver with ability to effectively lead our growing Clinical Operations team. This individual will be responsible for successful management of clinical trials from protocol concept through the clinical study report and must be able to provide direct guidance to team members and demonstrate strong decision-making capabilities. Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations are essential. Responsibilities:- Ensures clinical trials are executed in compliance with ICH/Google Cloud Platform (Good Clinical Practice) guidelines, regulations, and company SOPs
- Collaborates in the RFP, selection, qualification, and management of vendors to support clinical trial execution
- Conducts new site initiations and trainings
- Contributes to the development and management of SOPs, site budgets, timelines, and metrics; ensures completion of study deliverables; provides status update reports
- Assists in forecasting clinical trial material & ancillary supplies
- Plans and executes study-specific meetings (e.g., investigator meetings, clinical sub team meetings) as needed
- Review monitoring reports and assess non-compliance trends
- Review site audit reports to ensure quality and resolution of site-related issues
- Ensures timely review of protocol deviations and assess impact on study data
- Represents Clin Ops on Product Complaint Committee & audit readiness.
- Partners with clinical scientists to design clinical trial protocols consistent with the clinical development plan
- Participates in departmental planning sessions, SOP development, clinical document reviews
- Manages clinical trial site relationships, co-monitors and manages junior staff as needed
- Line manage CTMs and CTAs and help organically grow the department
- Bachelor's degree in life sciences and 5+ years of direct clinical trial experience in Pharmaceutical, Biotech or CRO required,
- A minimum of 3+ years of global trial management lead/oversight experience
- Working knowledge of global regulatory requirements to set up a trial
- Sound knowledge of the scientific and clinical research processes
- Experience managing external vendors and TMFs
- Preferences include experience in rare disease, CNS and/or Ophthalmology, as well as IND and NDA experience
- Must be able to travel occasionally (approximately 20%)
Vacancy expired!