Associate Director, Clinical Operations Program Lead
Biogen
9 days ago
Remote friendly (United States)
United States
Operations
Responsibilities:
- Lead clinical development program operations strategy, planning, and implementation; serve as the program-level Clinical Operations representative.
- Provide advanced strategic and operational insights (decision points, risk, timelines, feasibility, financials) to support Integrated Asset Plans (IAP), clinical development plans, and related initiatives.
- Accountable for program level clinical operations deliverables; develop high-level clinical study operational strategy based on CDP and program objectives.
- Bring the “operational voice” into governance meetings/presentations; lead COPL input for governance materials and align with Head of Clinical Operations.
- Act as program champion/hub; oversee implementation considering technical, vendor, quality site/Investigator, geography, and patient-centric considerations.
- Facilitate communication between DST and Clinical Operations to drive risk management and resolve technical issues.
- Engage proactively with Biogen and partners (e.g., CROs/vendors); escalate delivery issues and drive risk mitigation strategies.
- Develop and execute Program Operational Plans (POP); cascade within Biogen to sub-functions.
- May contribute to due diligence/business evaluations (external CDP review, internal scenario/timeline development, resource plans).
Required Qualifications/Skills:
- BS in scientific/health discipline; MS/PhD/PharmD/MBA/MPH preferred.
- 10+ years in Biotech/Pharma drug development/clinical research/operational strategy; at least 3 years in Program Operational Delivery.
- Demonstrated program/project management (risk assessment/mitigations, timeline/budget management, contingency planning).
- Leadership and ability to influence matrix teams; strong communication, organization, problem solving, conflict resolution.
- Ability to leverage data to develop executable timelines.
- Experience across complex therapeutic areas; agile application of disease information.
- Deep operational expertise delivering global programs across phases 1–4 and LCM.
- Experience facilitating CDPs with multiple functions strongly desired.
Benefits (highlights): Medical/dental/vision/life insurance, paid vacation and holidays, 401(k) match, tuition reimbursement.
- Lead clinical development program operations strategy, planning, and implementation; serve as the program-level Clinical Operations representative.
- Provide advanced strategic and operational insights (decision points, risk, timelines, feasibility, financials) to support Integrated Asset Plans (IAP), clinical development plans, and related initiatives.
- Accountable for program level clinical operations deliverables; develop high-level clinical study operational strategy based on CDP and program objectives.
- Bring the “operational voice” into governance meetings/presentations; lead COPL input for governance materials and align with Head of Clinical Operations.
- Act as program champion/hub; oversee implementation considering technical, vendor, quality site/Investigator, geography, and patient-centric considerations.
- Facilitate communication between DST and Clinical Operations to drive risk management and resolve technical issues.
- Engage proactively with Biogen and partners (e.g., CROs/vendors); escalate delivery issues and drive risk mitigation strategies.
- Develop and execute Program Operational Plans (POP); cascade within Biogen to sub-functions.
- May contribute to due diligence/business evaluations (external CDP review, internal scenario/timeline development, resource plans).
Required Qualifications/Skills:
- BS in scientific/health discipline; MS/PhD/PharmD/MBA/MPH preferred.
- 10+ years in Biotech/Pharma drug development/clinical research/operational strategy; at least 3 years in Program Operational Delivery.
- Demonstrated program/project management (risk assessment/mitigations, timeline/budget management, contingency planning).
- Leadership and ability to influence matrix teams; strong communication, organization, problem solving, conflict resolution.
- Ability to leverage data to develop executable timelines.
- Experience across complex therapeutic areas; agile application of disease information.
- Deep operational expertise delivering global programs across phases 1–4 and LCM.
- Experience facilitating CDPs with multiple functions strongly desired.
Benefits (highlights): Medical/dental/vision/life insurance, paid vacation and holidays, 401(k) match, tuition reimbursement.