Clinical Operations Program Lead
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Job Description
Clinical Operations Program Lead overseeing clinical development strategy for transplant programs at Biogen. Leading teams and ensuring compliance with clinical development standards.
Responsibilities:
- Provide team leadership and line management for clinical trial managers and specialists, fostering best practices within the disease unit.
- Champion career development and performance management for team members.
- Develop operational timeline scenarios, ensuring feasibility and alignment with financial objectives.
- Lead the strategy, planning, and implementation of clinical development program operations across assigned programs.
- Serve as the lead program-level representative, driving recommendations to clinical development plans through strategic and operational insights.
- Oversee program-level clinical operations deliverables, ensuring adherence to timelines, quality standards, and budget expectations.
- Facilitate cross-functional collaboration to achieve clinical program objectives.
- Ensure compliance with GCP, ICH guidelines, and regulatory requirements throughout clinical development activities.
Requirements:
- B.A. or B.S. in a scientific discipline; advanced degree preferred
- Scientifically and clinically astute with extensive operational experience and team leadership skills
- 12+ years of clinical research study and program management experience, including 8+ years managing outsourced clinical trials within sponsor companies
- Proven ability to oversee multiple studies and programs, with scientific learning agility to address evolving pipelines and external landscapes
- Deep cross-functional knowledge of drug development and clinical development across various trial phases (Phase I–IV) and therapeutic areas
- Strong line management experience, with the ability to mentor highly professional staff
- Exceptional leadership, communication, organizational, and problem-solving skills
- Thorough knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development
Benefits:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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