Director, Clinical Operations Program Leadership (COPL)
Biogen
August 06, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities
- Lead strategy, planning, and implementation of clinical development program operations for QSDO (Clinical Trial Delivery Unit); serve as program-level QSDO representative to DAT and as needed to PDC.
- Provide advanced strategic and operational expertise (decision points, risk, timeline scenarios, feasibility, financials) to support Integrated Asset Plans (IAP), clinical development plans, and key initiatives.
- Accountable for program-level clinical operations deliverables: develop and refine high-level clinical study operational strategy based on CDP and program objectives; bring the “operational voice” into governance.
- Develop and oversee program operational strategy with technical, vendor, quality site/investigator, geographical, and patient-centric considerations.
- Facilitate communication between DAT and QSDO leadership/sub-functions; incorporate risk management and resolve technical issues.
- Lead program study timeline development and ongoing refinement; provide rigorous status/updates and aligned recommendations to support strategic decisions.
- Oversee QSDO delivery to meet governance-approved timelines and patient recruitment goals; proactively engage CROs/vendors and escalate delivery issues.
Required Skills / Qualifications
- Undergraduate degree in scientific/health-related 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 capacity.
- Strong project/program management (risk assessment/mitigations, timeline/budget, contingency planning).
- Leadership in matrix environments; strong communication, problem-solving, conflict resolution.
- Experience building executable timelines from data; deep global clinical program experience (Ph 1–4 and LCM).
- Experience facilitating Clinical Development Plans (CDPs) with multiple functions strongly desired.
Benefits (selected)
- Base compensation range: $209,000–$288,000; eligible for short- and long-term incentives.
- Medical/Dental/Vision/Life insurance; fitness reimbursement; 15+ days paid vacation; 401(k) with match; tuition reimbursement up to $10,000/year.
- Lead strategy, planning, and implementation of clinical development program operations for QSDO (Clinical Trial Delivery Unit); serve as program-level QSDO representative to DAT and as needed to PDC.
- Provide advanced strategic and operational expertise (decision points, risk, timeline scenarios, feasibility, financials) to support Integrated Asset Plans (IAP), clinical development plans, and key initiatives.
- Accountable for program-level clinical operations deliverables: develop and refine high-level clinical study operational strategy based on CDP and program objectives; bring the “operational voice” into governance.
- Develop and oversee program operational strategy with technical, vendor, quality site/investigator, geographical, and patient-centric considerations.
- Facilitate communication between DAT and QSDO leadership/sub-functions; incorporate risk management and resolve technical issues.
- Lead program study timeline development and ongoing refinement; provide rigorous status/updates and aligned recommendations to support strategic decisions.
- Oversee QSDO delivery to meet governance-approved timelines and patient recruitment goals; proactively engage CROs/vendors and escalate delivery issues.
Required Skills / Qualifications
- Undergraduate degree in scientific/health-related 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 capacity.
- Strong project/program management (risk assessment/mitigations, timeline/budget, contingency planning).
- Leadership in matrix environments; strong communication, problem-solving, conflict resolution.
- Experience building executable timelines from data; deep global clinical program experience (Ph 1–4 and LCM).
- Experience facilitating Clinical Development Plans (CDPs) with multiple functions strongly desired.
Benefits (selected)
- Base compensation range: $209,000–$288,000; eligible for short- and long-term incentives.
- Medical/Dental/Vision/Life insurance; fitness reimbursement; 15+ days paid vacation; 401(k) with match; tuition reimbursement up to $10,000/year.