Director, Clinical Operations Program Lead
- Full-time
- Region: US
- Department: Research & Development
Job Description
Make the most meaningful impact of your career in this rewarding role with Biogen, an established pioneer in biotechnology. This is your rare opportunity to join the Clinical Operations Program Leadership (COPL) team.
The Director, Clinical Operations Program Lead, is responsible for leading the strategy, planning, oversight and implementation in the Global Clinical Operations (GCO) organization and contributing as the lead program level GCO representative to the R&D Project Team. You will be responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials ) perspective to meaningfully contribute and make recommendations to integrated development plans, clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs.
What You’ll Do
- Lead the development and ongoing refinement of program level study timelines and scenarios
- Provide rigorous, objective information (status and updates) and aligned GCO recommendations to R&D project team to support strategic project decisions
- Take overall accountability for GCO delivery of the clinical studies within a program
- Engage proactively with Biogen and partner stakeholders (e.g. CROs) and appropriately leverage GCO governance to support clinical program execution
- Responsible for escalating CRO delivery issues to senior leadership and driving delivery of mitigation strategies to maintain program timelines.
- Champion synergies among other programs, and development units to enhance excellence in program planning and oversight
Who You Are
Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and influence at highest levels of program leadership. Decisive, analytical and self-confident, you are determined to make a difference on the lives of others through your leadership and ability to inspire excellence.
Qualifications
Required Skills
- B.A. or B. Sc. in a scientific discipline
- 12+ years’ experience in drug development, clinical research and operations experience including responsibility for ensuring studies and programs are executed to quality, timelines, and budget.
- Demonstration of project/program management skills including risk assessment, timeline, budget management and contingency planning.
- Demonstration of effective team leadership of matrix teams.
- Excellent communication, management, and organizational skills, along with problem solving, conflict resolution, and team building skills.
- Experiencing identifying and leveraging relevant data and information to develop well-conceived and executable timelines.
- Deep operational expertise with planning and delivering global clinical programs and studies
Preferred Skills
- Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions
- Master’s or Ph. D in a related field
- Experience across several complex therapeutic areas particularly Neurodegenerative
Additional Information
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
All your information will be kept confidential according to EEO guidelines.