Associate Director, Clinical Sciences, Oncology

About the role

This role will support Oncology Therapeutic programs, specifically supporting the Clinical Study Lead in the development, execution and evaluation of Phase 1–3 clinical studies. The principal responsibility for this role is to ensure the comprehensive data quality of clinical studies to support both internal governance decisions and regulatory submissions.

Responsibilities

• Oversee end-to-end delivery of clinical trial protocols in conjunction with the Clinical Study Lead and the broader Clinical Trial Team, including study design, initiation, medical safety data monitoring, data dissemination and closeout activities.
• Collaborate with Clinical Operations to participate in the start-up of global clinical studies, ensuring on-schedule site activation and subject enrollment.
• Design and implement clinical study parameters to minimize operational risk and increase study site performance and efficiency.
• Contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
• Perform and coordinate clinical data review and analysis, including review of case report forms, data listings, medical coding and patient profiles to ensure proper and complete verification of clinical data.
• Provide review and interpretation of clinical data and ensure timely execution of deliverables in collaboration with the Clinical Trial Team and external partners.
• Support managing study sites to ensure that study treatment discontinuation or other safety decisions are made in alignment with the protocol, in collaboration with the Clinical Study Lead and Clinical Safety & Pharmacovigilance.
• Assist in the development of content for Investigator Meetings, investigator engagements and Advisory Board meetings.
• Author and review clinical study documents in compliance with regulatory standards, including clinical protocols, informed consent documents, Development Safety Update Reports (DSUR) and clinical components of Investigator Brochures, INDs and marketing applications.
• Support process improvements and participate in continuous improvement initiatives related to the clinical trial delivery operating model.

Requirements

• PhD, PharmD, Master’s or advanced nursing degree with significant scientific and clinical oncology knowledge.
• Pharmaceutical/biotechnology company experience and substantial knowledge of drug development.
• Minimum of 8 years of clinical development experience within a pharmaceutical/biotechnology company.
• Significant experience ensuring clinical trial data integrity, data analysis (including exploratory analyses) and data presentation.
• Excellent written and oral communication, and presentation skills.
• Ability to travel up to 15% for work with study sites and attendance at national and international scientific congresses.

Preferred Qualifications

• Outstanding scientific and clinical oncology knowledge that results in the conduct of well-executed clinical research.
• History of successfully operating in a matrix environment with highly developed interpersonal and communication skills.
• Personal and professional commitment to the highest ethical standards.
• Capability to contribute to both early- and late-stage clinical development programs through close collaboration with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial.

Benefits

• Competitive healthcare and voluntary benefit programs to support unique needs.
• Holistic approach to well-being, including fitness, mindfulness and mental health support.
• Family planning benefits, including fertility, adoption and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days and a discretionary year-end shutdown.
• Savings and investment programs to support future planning.
• Location-specific perks and extras.

Pay

The salary range for this role is $158,600.00 – $285,500.00. Position within the range will be based on competencies, education, qualifications, experience, skills, performance and business needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation or equity awards, subject to company plan eligibility criteria and individual performance.