Director, Clinical Operations Program Leadership (COPL)

Biogen•Cambridge, MA

9d•$209,000 - $288,000

About The Position

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. The COPL serves as the program champion and hub of the program within the QSDO organization. This individual develops and oversees implementation of program operational strategy, ensuring appropriate considerations that include but are not limited to technical, vendor, quality site/ Investigator, geographical and patient centric considerations for the program lifecycle. She/He facilitates communication between the DAT and QSDO (inclusive of leadership and sub-functions) to provide direction, incorporate appropriate risk management measures and ensure resolution of technical issues. This individual may be responsible for one highly complex, multiple medium complex clinical programs and/or programs with external collaborators. 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.

Requirements

Undergraduate degree in a scientific or health related discipline.
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.

Nice To Haves

Advanced scientific or business degree or equivalent experience (MS/PhD/PharmD/MBA /MPH) preferred.

Responsibilities

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.

Benefits

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