Director Clinical Sciences

Role Summary

Locations: Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US.

As Director, Clinical Sciences, 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, 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.

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

Qualifications

• Required: Bachelor's degree in life sciences/healthcare/nursing
• Preferred: Advanced degree
• Required: 10+ years of industry experience with strong knowledge of Good Clinical Practice (GCP) and drug development processes across Phase 1–3 studies
• Preferred: Oncology/immuno-oncology experience is highly desirable
• Required: Proven expertise in global clinical study execution within pharmaceutical companies or CROs
• Preferred: Academic research experience is valuable
• Required: Strong understanding of clinical data collection principles; ability to utilize tools like EDC systems or Excel for data analysis
• Preferred: Experience driving process improvements
• Required: Collaborative mindset with the ability to influence without authority in a matrixed environment
• Required: Highly adaptable working style with excellent multitasking skills under time pressure while maintaining quality standards
• Required: Proficiency in English (written and spoken)