Publicly Traded Biopharmaceutical company in Watertown, MA is expanding for their high profile clinical development trials.
The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program.
This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III).
The Director will be a leader in the organization who knows how to manage a team internally, at our clinical sites, and with our vendors.
- Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards
- Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
- Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones
- Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program
- Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
- Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
- Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
- Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports
- In collaboration with the Head of Clinical Operations, hire, train and develop the Clinical Operations team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence
What skills and experience you’ll bring :
- BA / BS preferably in a health-related field; preferred MA / MS degree with major in biological, life science, nursing or related field
- 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry
- Prior experience building and leading a team is a plus
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GCP
- Ability to manage multiple competing priorities and adapt to changes
- Strong communication, interpersonal, and problem solving skills
- Must be comfortable working in a fast-paced environment
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