Clinical Operations Program Lead
Biogen
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $194,000 - $267,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementprogram managementoperational timeline developmentclinical development strategybudget managementcross-functional collaborationGCP complianceICH guidelinesregulatory requirementsdrug development
Soft skills
team leadershipcareer developmentperformance managementcommunicationorganizational skillsproblem-solvingmentoringscientific learning agilitystrategic insightsquality standards adherence