- Work with the VP, Clinical Operations to manage clinical programs in Phase 1-3 of clinical trials
- Oversee the development of clinical trial project timelines and ensure communication and understanding of risks and challenges; establish plans and monitor metrics; ensure that timelines are accurate and comprehensive
- Ensure GCP compliance and consistency in global trial execution
- Manage study budgets, including Task Orders, Change Orders, expense accruals, invoice approval, and financial reconciliation
- Work with department heads to ensure all clinical and non-clinical deliverables are in place or scheduled to support clinical development plan; e.g. CMC, toxicology, DMPK, regulatory affairs, biostatistics, data management
- Provide operational leadership in clinical development strategy discussions; assess feasibility of operationalizing various strategic options
- In conjunction with Clinical Operations leadership, formulate and execute a cross-functional development plan that includes identifying key milestones and establishing program budget
- BA/BS required. Advanced scientific degree is a plus.
- At least 8 years of hands-on experience in clinical trials management or clinical research in biotech/pharma industry
- Demonstrated success in clinical development, particularly in Phase 1-3 clinical trials across multiple therapeutic areas
- Experience with hepatological, GI, or endocrine indications preferred
- Strong project management skills and general understanding of project management tools; experience with SmartSheets a plus
- Extensive experience in the selection and oversight of clinical CROs
- Ability to perform in fast-paced, dynamic, constantly evolving environment
- Excellent communication and organizational skills and attention to detail
- Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals
- Embraces and embodies Boston Pharmaceuticals' corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team
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Director, Clinical Operations - Cambridge, United States - Boston Pharmaceuticals
Description
Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases.
Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH).
Our second investigational program, BOS-342, is a targeted immunotherapy currently being studied in a Phase 1 clinical trial for the treatment of liver cancer.
Position SummaryThe Director, Clinical Operations is responsible for oversight and execution of the clinical development plan for the assigned development programs.
They will also work closely with the Clinical Operations leadership and other cross-functional team members on all aspects of program oversight and management.
The position requires excellent leadership skills, deep experience in drug development and networking capabilities to maximize the use of external resources (CRO's, KOL's, consultants etc.) and to integrate with internal domain expertise.
Roles & ResponsibilitiesQualifications:
