New · posted Nov 1
Biogen · Biotechnology
Director, Clinical Operations Program Leadership (COPL)
- Research Triangle Park, NC
- On-site
- Full-time
- Director
The role
The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level clinical operations deliverables. The COPL is accountable for developing a high-level clinical study operational strategy based on the CDP and key program level objectives. The COPL is accountable to bring the “operational voice” into governance meetings and presentations.
What you need
Required Skills
- 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.
- 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.
Job Level: Management
What you'll do
- 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.
Pay and benefits
$198,000 – $272,250 a year
Employer providedAdditional Information
The base compensation range for this role is: $198,000.00-$272,250.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Medical, dental, vision and life insurance
Cash bonus and equity incentives
401(k) with company match
Employee stock purchase plan
Paid vacation, holidays and parental leave
Tuition reimbursement up to $10,000 per year
Where you'll work
Research Triangle Park, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Research Triangle Park, NC
From the posting
About Biogen
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Clinical Operations roles at this level.
This roleEmployer provided
Director roles in the US35 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $198,000 | — | $272,250 |
| All US (middle half) | $202,500 | $233,000 | $243,000 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 93 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Career resources on Clinical Operations
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct5
- Collaboration and leadership5
- Quality systems and risk1
Company hiring pulse
Biogen on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 4
- Locations
By discipline
- Clinical12 52%
- Quality7 30%
- Regulatory4 17%
By level
- Director7 30%
- Senior & Principal7 30%
- VP & Executive4 17%
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Director, Clinical Operations Program Leadership (COPL) at Biogen
Open until filled. $198K–$272K a year, employer provided.