Director, Clinical Operations Program Leadership (COPL)
Biogen
19 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Director, Clinical Operations Program Leadership (COPL)
Responsibilities:
- Lead strategy, planning, oversight, and delivery of program-level clinical operations deliverables in QSDO/CTDU.
- Develop and refine program operational strategy and study timelines/scenarios to support Integrated Asset Plans and clinical development plans.
- Provide strategic and operational expertise (risks, decision points, feasibility, timelines, feasibility/financials) to DAT and other teams; serve as “operational voice” in governance.
- Champion the program within QSDO; facilitate communication across DAT and QSDO to drive risk management, resolve technical issues, and ensure quality/ethics/cost-efficient delivery and patient recruitment.
- Own QSDO Program Operational Plan (POP); integrate stage-appropriate needs and cascade vision/strategy to sub-functions.
- Proactively engage Biogen and external stakeholders (CROs/vendors), leveraging governance and escalating delivery issues; drive risk mitigation.
Required Skills/Qualifications:
- Undergraduate degree in scientific/health discipline; MS/PhD/PharmD/MBA/MPH preferred.
- 12+ years biotech/pharma drug development/clinical research/operational strategy; at least 3 years in program operational delivery.
- Program/project management with risk assessment, timeline/budget management, and contingency planning.
- Leadership and matrix influence; strong communication and conflict/problem-solving skills.
- Ability to use relevant data to create executable timelines.
- Experience across complex therapeutic areas; clinical/scientific agility.
- Deep operational expertise delivering global programs across Ph 1–4 and LCM.
- Experience facilitating Clinical Development Plans (CDPs) with multiple functions (strongly desired).
Benefits (as listed): Medical, Dental, Vision, Life; fitness reimbursement; short/long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown; company holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups.
Compensation: Base range $209,000–$288,000.
Responsibilities:
- Lead strategy, planning, oversight, and delivery of program-level clinical operations deliverables in QSDO/CTDU.
- Develop and refine program operational strategy and study timelines/scenarios to support Integrated Asset Plans and clinical development plans.
- Provide strategic and operational expertise (risks, decision points, feasibility, timelines, feasibility/financials) to DAT and other teams; serve as “operational voice” in governance.
- Champion the program within QSDO; facilitate communication across DAT and QSDO to drive risk management, resolve technical issues, and ensure quality/ethics/cost-efficient delivery and patient recruitment.
- Own QSDO Program Operational Plan (POP); integrate stage-appropriate needs and cascade vision/strategy to sub-functions.
- Proactively engage Biogen and external stakeholders (CROs/vendors), leveraging governance and escalating delivery issues; drive risk mitigation.
Required Skills/Qualifications:
- Undergraduate degree in scientific/health discipline; MS/PhD/PharmD/MBA/MPH preferred.
- 12+ years biotech/pharma drug development/clinical research/operational strategy; at least 3 years in program operational delivery.
- Program/project management with risk assessment, timeline/budget management, and contingency planning.
- Leadership and matrix influence; strong communication and conflict/problem-solving skills.
- Ability to use relevant data to create executable timelines.
- Experience across complex therapeutic areas; clinical/scientific agility.
- Deep operational expertise delivering global programs across Ph 1–4 and LCM.
- Experience facilitating Clinical Development Plans (CDPs) with multiple functions (strongly desired).
Benefits (as listed): Medical, Dental, Vision, Life; fitness reimbursement; short/long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown; company holidays; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups.
Compensation: Base range $209,000–$288,000.