Director, Clinical Operations Program Leadership

Biogen

Director of Clinical Operations at Biogen leading clinical development strategy and program delivery. Accountable for strategic planning and operational execution in clinical trials.

Posted 8/1/2026full-timeResearch Triangle Park • Massachusetts, North Carolina • 🇺🇸 United StatesSenior💰 $209,000 - $288,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in drug development and clinical research within the Biotech/Pharma industry, with a strong focus on program operational delivery, project management, and strategic planning. Proven ability to lead cross-functional teams, communicate effectively with senior leadership, and develop executable timelines for clinical studies.

Highest-signal resume keywords

Program Operational DeliveryProject ManagementClinical Development Plans (CDPs)Risk Assessment and MitigationCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug DevelopmentClinical ResearchOperational StrategyTimeline ManagementBudget ManagementContingency PlanningTherapeutic Area ExpertiseGlobal Clinical ProgramsClinical Study ExecutionData Analysis

Soft Skills

Team LeadershipInfluencing SkillsProblem SolvingConflict ResolutionTime Management

Certifications & Qualifications

Undergraduate Degree in Scientific DisciplineAdvanced Scientific or Business Degree (MS/PhD/PharmD/MBA/MPH)

Industry Keywords

BiotechPharmaClinical DevelopmentGovernance FrameworkStakeholder EngagementCRO ManagementPatient RecruitmentOperational ConsistencyRegulatory DevelopmentLifecycle Management (LCM)

About the role

Key responsibilities & impact

Leads the development and ongoing refinement of program level study timelines and scenarios in order to contribute to the Integrated Asset Plan (IAP) and other high-level strategic plans
Provide rigorous, objective information (status and updates) and aligned QSDO recommendations to DAT to support strategic project decisions
Takes overall accountability for QSDO delivery of the clinical studies within a program and provides appropriate oversight to ensure a high quality, ethical, cost-efficient way to meet governance approved timelines and patient recruitment goals
Ability to learn and adapt to the organizational governance framework and associated processes
Accountable to lead the COPL input and development of governance presentations and/or memos including integration of the operational voice
Ability to engage/communicate key messages, including risks, to senior and executive level functional leaders outside of QSDO
Ability to reach technical alignment on governance materials with the Head of QSDO and Head of CTDU in accordance with associated governance timelines
Engage proactively with Biogen and partner stakeholders (e.g. CROs, vendors) and appropriately leverage QSDO governance to support clinical program execution
Responsible for escalating CRO/FSP, vendor delivery issues to senior leadership at vendor partner level, driving delivery of risk mitigation strategies to maintain and deliver program timelines
Responsible for the development and execution of a QSDO Program Operational Plan (POP) accounting for the therapeutic area and underlying science and opportunities for innovation and operational consistency as well as the future clinical, regulatory, and commercial development plan for the molecule
Proactively integrates stage-appropriate needs into operational strategy
Cascades the POP within QSDO to appropriate sub functions to establish vision and strategic framework for successfully delivery at the study level and with individual areas of technical expertise
May participate as a functional contributor to due diligence/business evaluations including the review of external CDP and strategy, the development of internal timelines, scenarios and recommendations, the review of external capabilities and the development of QSDO resource plans for potential new clinical candidates

Requirements

What you’ll need

Undergraduate degree in a scientific or health-related discipline
Advanced scientific or business degree or equivalent experience (MS/PhD/PharmD/MBA/MPH) preferred
Minimum of 12 years’ experience within a Biotech/Pharma environment in drug development, clinical research, and operational strategy experience, ensuring studies and programs are executed to quality, timelines, and budget
At least 3 years of this time in a Biotech/Pharma Program Operational Delivery capacity is required
Demonstration of project/program management skills including risk assessment and identification of mitigations, timeline and budget management, and contingency planning
Demonstration of effective team leadership and an ability to effectively influence matrix teams
Excellent communication, time management, and organizational skills, along with problem solving, conflict resolution, and team building skills
Experience identifying and leveraging relevant data and information to develop well-conceived and executable timelines
Experience across several complex therapeutic areas
Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
Deep operational expertise
Experience planning and delivering global clinical programs and studies through all stages of development Ph 1-4 and LCM
Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation