Senior Director, Clinical Program Lead, Oncology

About the role

The Global Clinical Program Lead serves as a matrix leader of a cross-functional Clinical Program Team responsible for the operation of assigned clinical program(s). This role involves developing and implementing regional clinical operations strategies and initiatives, ensuring the successful conduct of clinical trials in compliance with applicable regulations, guidelines, and procedures. The position manages clinical project timelines, budgets, deliverables, and communications, serving as the main point of contact for functional issues, including CRO/vendor performance and resource concerns.

Reporting to the Vice President of Global Clinical Operations, this role is responsible for project management deliverables in accordance with agreed timelines and quality standards.

Responsibilities

• Leads multiple clinical studies in parallel, through direct reports and/or vendors.
• Oversees all aspects of study execution, with or without a CRO, including operational plans and timelines to achieve on-time enrollment and study completion.
• Promotes effective partnership among cross-functional teams and provides day-to-day direction for the core team.
• Leads problem-solving and resolution efforts, offering creative recommendations to meet goals and mitigate risks.
• Strategically supports protocol finalization, optimizing trial design and execution, identifying barriers to timely study execution, and proposing solutions.
• Develops and coordinates operational plans for clinical studies, including timelines, drug forecasts, safety plans, monitoring plans, and study management plans.
• Shapes regional Clinical Operations teams, including in-house members, CROs, vendors, and suppliers, ensuring work quality, timeliness, and budget adherence.
• Manages the performance and career development of direct and/or indirect reports.
• Drives clinical trial database construction, data collection, and assists with audits to ensure data integrity.
• Manages CRO and site budgets, communicates budget deviations, and proposes solutions for variances.
• Influences clinical trial recruitment strategies, evaluates enrollment against targets, and collaborates with investigational sites to meet or exceed enrollment goals.
• Accountable for Clinical Operations financial planning, forecasting, and budget management, monitoring actuals against projections.
• Ensures compliance with regulatory requirements by monitoring CROs, vendors, and adherence to company SOPs, GCPs, FDA, and international regulations.
• Conducts regular meetings with team members to ensure project milestones are met.
• Serves as the primary escalation contact with vendors, including leading proposal development and bid-defense processes.

Qualifications

• BS/BA degree in a scientific or health-related discipline; advanced scientific degree or equivalent experience preferred.
• Experience leading teams in the APAC region.
• Minimum of 15 years of experience in drug development, clinical research, and operational strategy, including responsibility for ensuring studies and programs are executed to quality, timelines, and budget (biotech/pharma experience preferred).
• Small biotechnology company experience is a plus.
• Oncology experience is required.
• Demonstrated project/program management skills, including risk assessment, timeline and budget management, and contingency planning.
• Line management experience, including talent identification, development, coaching, performance management, and resource allocation.
• Effective team leadership of matrix teams.
• Excellent communication, management, organizational, problem-solving, conflict resolution, and team-building skills.
• Experience across several complex therapeutic areas.
• Experience planning and delivering U.S.-based and global clinical programs and studies.
• Multi-study experience managing early through late-stage clinical trials.
• Working knowledge of clinical trial conduct, GCPs, and FDA regulations.

This position is classified as a corporate office role. In accordance with the New York state employer convenience rule, New York state income taxes will be withheld for all corporate office employees, regardless of work location.

Pay

Base Salary Range of $220,000 - $270,000 plus annual bonus and long-term incentives.

Benefits

• Fidelity 401(k) with company match.
• Anthem Premier PPO and HDHP insurance plans.
• Company-paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.