Director Clinical Sciences
About The Position
As Director, Clinical Science, you will play a pivotal role in driving high-impact clinical and regulatory documentation that powers successful health authority interactions and accelerates time to approval. By transforming complex trial data into sharp, decision-ready insights, you will elevate data quality, patient safety, and program strategy across Phase 1–3 studies. Operating at the center of a dynamic and cross-functional network, you will shape integrated development plans that define and differentiate our oncology portfolio, contributing directly to our mission of advancing groundbreaking therapies for patients worldwide.
Requirements
- Bachelor’s degree in life sciences/healthcare/nursing; advanced degree preferred
- 10+ years of industry experience with strong knowledge of Good Clinical Practice (GCP) and drug development processes across Phase 1–3 studies; oncology/immuno-oncology experience is highly desirable
- Proven expertise in global clinical study execution within pharmaceutical companies or CROs; academic research experience is also valuable
- Strong understanding of clinical data collection principles; ability to utilize tools like EDC systems or Excel for data analysis; experience driving process improvements is a plus
- Collaborative mindset with the ability to influence without authority in a matrixed environment
- Highly adaptable working style with excellent multitasking skills under time pressure while maintaining quality standards
- Proficiency in English (written and spoken)
Responsibilities
- Design clinical trials to evaluate the safety and efficacy of investigational drugs, including protocol development, patient population identification, endpoint selection, and study design determination
- Oversee clinical development activities to ensure trials are conducted in accordance with protocols, regulatory requirements, and ethical standards while monitoring study progress and managing adverse events
- Lead or contribute to the creation of critical study-level documents such as protocols, Investigator’s Brochures, briefing books, safety updates, submission dossiers, CTR documents, and publications
- Address regulatory/health authority queries under the guidance of Clinical Development Leads while ensuring compliance with guidelines
- Develop Clinical Development Plans (CDP), Integrated Evidence Plans (IEP), and clinical components of Target Product Profiles (TPP)
- Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, medical affairs, and CRO partners for successful execution of clinical programs
- Provide training materials for protocol implementation and share best practices with internal teams and external stakeholders such as investigator sites or CROs
Benefits
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Director
