Director, Clinical Operations Program Leadership (COPL)

About the role

The Director, Clinical Operations Program Leadership (COPL) leads the strategy, planning and implementation of clinical development program operations within the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL acts as the lead program-level QSDO representative to the Development Asset Team (DAT) and is brought in by the Product Development and Commercialization team (PDC), bringing an operational voice to Integrated Asset Plans, clinical development plans and other key initiatives. The role may cover one highly complex program and/or several medium-complex programs with external collaborators.

Key responsibilities

• Develop and oversee the program operational strategy, including technical, vendor, quality, site/investigator, geographical and patient-centred considerations, and cascade the Program Operational Plan (POP) to QSDO sub-functions.
• Lead the development of program-level study timelines and scenarios, and provide status updates and QSDO recommendations to the DAT to support strategic decisions.
• Take overall accountability for QSDO delivery of clinical studies, ensuring quality, ethics, cost-efficiency and governance-approved timelines and recruitment goals.
• Contribute to governance presentations and memos, and communicate risks to senior and executive leaders outside QSDO.
• Escalate CRO and vendor delivery issues to senior leadership and drive risk mitigation strategies.
• Participate in due diligence and business evaluations, including timelines, scenarios, capability reviews and resource plans for new clinical candidates.

Required profile

• Undergraduate degree in a scientific or health-related discipline; advanced degree (MS/PhD/PharmD/MBA/MPH) or equivalent experience preferred.
• At least 12 years of experience in a biotech/pharma environment in drug development, clinical research and operational strategy, including at least 3 years in a program operational delivery capacity.
• Experience across several complex therapeutic areas and planning and delivering global clinical programs through Ph 1-4 and LCM.

Required skills

• Project and program management, including risk assessment, timeline and budget management and contingency planning.
• Team leadership and the ability to influence matrix teams.
• Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired.

What we offer

• Base compensation of $198,000-$272,250, plus short- and long-term incentives such as cash bonus and equity.
• Medical, dental, vision and life insurance, disability insurance, and wellness programs.
• 15 days of paid vacation, up to 12 company-paid holidays, 80 hours of sick time per year, and paid maternity and parental leave.
• 401(k) with company match, employee stock purchase plan, tuition reimbursement up to $10,000 per year, and Employee Resource Groups.