Director, Clinical Sciences, Oncology

About the role

This role supports Oncology Therapeutic programs, specifically focusing on the Clinical Development Lead in the direction, execution, and evaluation of Phase 1-3 clinical studies. The primary responsibility is ensuring comprehensive data quality for clinical studies to support internal governance and regulatory submissions.

Responsibilities

• Contribute to regulatory and clinical program strategy, clinical trial design, and clinical study execution.
• Author and review clinical study documents in compliance with regulatory standards, including clinical protocols, informed consent documents, DSURs, and Investigator Brochures, INDs, and marketing applications.
• Collaborate with the Clinical Development Lead in overseeing clinical studies, leading studies with oversight, reviewing and interpreting clinical data, and ensuring timely execution of deliverables.
• Perform and coordinate clinical data review and analysis, including reviewing case report forms, data listings, medical coding, and patient profiles.
• Support managing study sites to ensure adherence to protocols, including treatment discontinuation and safety decisions.
• Participate in the start-up and execution of global clinical studies, designing and implementing study parameters to minimize operational risk and improve site performance and efficiency.
• Drive the strategy and messaging for Investigator Meetings, Advisory Board meetings, and training junior Clinical Science personnel.
• Support the evolution of the clinical science role and contribute to process updates and development workstreams related to the clinical trial delivery operating model.

Requirements

• A personal and professional commitment to the highest ethical standards.
• A high-performing, self-motivated individual with outstanding scientific and clinical oncology knowledge.
• Significant experience in clinical development within a pharmaceutical/biotechnology company.
• Significant experience with clinical study design and protocol development.
• Experience ensuring data integrity, conducting data analysis, and presenting data effectively.
• Excellent written and oral communication skills.
• Ability to travel up to 15% for work with study sites and attend scientific congresses.

Qualifications

• A PhD, PharmD, Masters’, or advanced nursing degree with significant scientific and clinical oncology knowledge.
• Minimum of 10 years of clinical development experience within a pharmaceutical/biotechnology company.
• Experience working in a matrix environment and demonstrating strong interpersonal and communication skills.

Skills

• Strong scientific and clinical oncology knowledge.
• Effective team player with experience in matrix environments.
• Proven ability to operate in early and late-stage clinical development programs.
• Experience with drug development processes and regulatory affairs.

Benefits

• Competitive healthcare coverage.
• Access to fitness, mindfulness, and mental health support.
• Fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, and global recharge days.
• Savings and investment options for future planning.
• Location-specific perks and extras.

Pay & Benefits

The salary range for this role is $183,800.00 - $330,300.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.