Executive Medical Director, Oncology Clinical Sciences

Role Summary

Executive Medical Director, Oncology Clinical Sciences in our Cambridge office. Role involves leading global development strategy for oncology therapeutics, overseeing integrated disease area strategies, and providing strategic clinical input across assigned studies and programs.

Responsibilities

• Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.
• Leads the Global Development Team (US, EU, and others) and oversees regional development teams; identify contingencies, risks, and mitigation strategies.
• Directs Development Team strategy and deliverables, including Development Strategy, Clinical Development Plan, and Clinical Protocols; assess scope, complexity, and budget implications; maintain a state-of-the-art development plan aligned with regulatory requirements.
• Make high-impact global decisions interpreting data from ongoing studies; provide recommendations affecting timelines, labeling, and development plans.
• Ensure regional strategies are articulated in global strategy documentation; brief stakeholders accordingly.
• Provide strategic input into global development strategies and plans for all OTAU compounds.
• Provide clinical and strategic support for evaluating external compounds (alliances and in-licensing opportunities).
• Interface with Medical Affairs to support product commercial efforts; contribute to regional KOL network; nominate GDT leaders and review external compounds as part of BD efforts.
• Liaison with Clinical Operations and Project Management for study planning and implementation logistics.
• Oversee critical reviews of synopses, protocols, IBs, and related clinical documents; ensure safety information is reviewed with Pharmacovigilance and Medical Monitor for assigned compounds.
• Lead clinical science activities in interactions with FDA/regulators and key opinion leaders; evaluate external interactions within global development context.
• Identify challenges and develop contingency plans; evaluate potential BD opportunities in region within global context; conduct due diligence for alliances or in-licensing opportunities.
• Serve as clinical contact point for ongoing alliance projects; maintain relationships with partners; manage clinical science staff and lead cross-functional teams.
• Hire, mentor, and develop staff; conduct performance reviews and development planning.

Qualifications

• MD or MD/PhD or internationally recognized equivalent; minimum 10 years in pharmaceutical research with at least 7 years in Phase I‚ÄìIV clinical development.
• Training/experience in Hematology and/or Medical Oncology, especially hematologic malignancies, highly preferred.
• Experience leading a clinical development team across multiple regions; BD experience (NDA/MAA) strongly preferred.
• Proven ability to lead and manage highly trained medical/scientific professionals; superior communication, strategic, interpersonal, and negotiating skills.
• Ability to predict issues proactively, solve problems, and drive decision-making in a multi-disciplinary, multi-regional matrix environment.
• Diplomacy and positive influence across multinational cultures.

Travel Requirements

• Willingness to travel to meetings or client sites, including overnight trips; some international travel may be required; approximately 25% travel.