Director, Clinical Operations Program Leadership (COPL)
Biogen
August 06, 2026
Remote friendly (Triangle, NC)
United States
Clinical Research and Development
Director, Clinical Operations Program Leadership (COPL)
Responsibilities:
- Lead clinical development program operations strategy, planning, oversight, and delivery within QSDO’s Clinical Trial Delivery Unit.
- Serve as program-level QSDO representative to the Development Asset Team (DAT) and support PDC; provide strategic and operational expertise (decision points, risk, timeline scenarios, feasibility, and financials).
- Develop and refine program level study timelines/scenarios to support Integrated Asset Plans (IAP) and high-level strategic plans.
- Bring the “operational voice” into governance meetings/presentations (including governance input/memos); communicate risks and recommendations to senior/executive leaders.
- Ensure high-quality, ethical, cost-efficient study delivery to governance-approved timelines and patient recruitment goals.
- Develop and oversee program operational strategy; incorporate technical, vendor, quality site/Investigator, geographic, and patient-centric considerations.
- Facilitate communication between DAT and QSDO leadership/sub-functions; drive resolution of technical issues and risk management.
- Engage with Biogen and partner stakeholders (e.g., CROs/vendors); escalate vendor delivery issues and drive risk mitigation.
- Develop and execute a QSDO Program Operational Plan (POP) and cascade it to relevant sub-functions.
- May contribute to due diligence/business evaluations and resource planning.
Qualifications:
- BS in scientific/health-related discipline; MS/PhD/PharmD/MBA/MPH preferred.
- 12+ years in biotech/pharma drug development/clinical research/operational strategy; at least 3 years in Program Operational Delivery.
- Project/program management with risk assessment, mitigation, timeline/budget management, and contingency planning.
- Leadership and matrix influence; strong communication, organization, problem solving, conflict resolution, and team building.
- Ability to leverage data to build executable timelines.
- Experience across complex therapeutic areas; scientifically/clinically agile.
- Deep operational expertise delivering global programs across Phase 1–4 and LCM.
- Strongly desired: experience facilitating Clinical Development Plans (CDPs) with multiple functions.
Benefits:
- Medical, dental, vision, and life insurance; fitness/wellness and fitness reimbursement; short- and long-term disability; 15 days paid vacation plus Dec 26–Dec 31 shutdown; up to 12 paid holidays + 3 personal significance days; 80 hours sick time; paid maternity and parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
Responsibilities:
- Lead clinical development program operations strategy, planning, oversight, and delivery within QSDO’s Clinical Trial Delivery Unit.
- Serve as program-level QSDO representative to the Development Asset Team (DAT) and support PDC; provide strategic and operational expertise (decision points, risk, timeline scenarios, feasibility, and financials).
- Develop and refine program level study timelines/scenarios to support Integrated Asset Plans (IAP) and high-level strategic plans.
- Bring the “operational voice” into governance meetings/presentations (including governance input/memos); communicate risks and recommendations to senior/executive leaders.
- Ensure high-quality, ethical, cost-efficient study delivery to governance-approved timelines and patient recruitment goals.
- Develop and oversee program operational strategy; incorporate technical, vendor, quality site/Investigator, geographic, and patient-centric considerations.
- Facilitate communication between DAT and QSDO leadership/sub-functions; drive resolution of technical issues and risk management.
- Engage with Biogen and partner stakeholders (e.g., CROs/vendors); escalate vendor delivery issues and drive risk mitigation.
- Develop and execute a QSDO Program Operational Plan (POP) and cascade it to relevant sub-functions.
- May contribute to due diligence/business evaluations and resource planning.
Qualifications:
- BS in scientific/health-related discipline; MS/PhD/PharmD/MBA/MPH preferred.
- 12+ years in biotech/pharma drug development/clinical research/operational strategy; at least 3 years in Program Operational Delivery.
- Project/program management with risk assessment, mitigation, timeline/budget management, and contingency planning.
- Leadership and matrix influence; strong communication, organization, problem solving, conflict resolution, and team building.
- Ability to leverage data to build executable timelines.
- Experience across complex therapeutic areas; scientifically/clinically agile.
- Deep operational expertise delivering global programs across Phase 1–4 and LCM.
- Strongly desired: experience facilitating Clinical Development Plans (CDPs) with multiple functions.
Benefits:
- Medical, dental, vision, and life insurance; fitness/wellness and fitness reimbursement; short- and long-term disability; 15 days paid vacation plus Dec 26–Dec 31 shutdown; up to 12 paid holidays + 3 personal significance days; 80 hours sick time; paid maternity and parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.