Associate Director, Clinical Operations – Program Lead

Biogen

Associate Director leading strategy and execution of clinical development program operations at Biogen. Responsible for operational oversight and delivery in the Clinical Operations organization.

Posted 5/26/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $162,000 - $223,000 per yearWebsite

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 Clinical Operations recommendations to DST to support strategic project decisions.
Takes overall accountability for Clinical Operations 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 Clinical Operations.
Ability to reach technical alignment on governance materials with the Head of Clinical Operations in accordance with associated governance timelines.
Engage proactively with Biogen and partner stakeholders (e.g. CROs, vendors) and appropriately leverage Biogen 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 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 Biogen 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 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 10 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.
Experiencing 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

drug developmentclinical researchoperational strategyproject managementrisk assessmenttimeline managementbudget managementClinical Development Plans (CDPs)Program Operational Plan (POP)therapeutic area expertise

Soft Skills

team leadershipinfluencecommunicationtime managementorganizational skillsproblem solvingconflict resolutionteam buildingadaptabilitystakeholder engagement

Certifications

MSPhDPharmDMBAMPH