Senior Global Development Scientist, Director

Job Title: Senior Global Development ScientistGaithersburg, MD or Cambridge, MA. Introduction to role:Are you ready to shape late-phase oncology trials that reach patients worldwide and change standards of care? In this role, you will be the clinical science driver behind pivotal studies, turning strategy into protocols and data into decisions that matter for patients, clinicians, and regulators.You will partner closely with a counterpart physician and an empowered cross-functional team to design, deliver, and interpret complex global studies.

From first concept through study delivery and registration, you will influence protocol integrity, enable robust recruitment, and translate evidence into clear recommendations for investment and approval. Can you envision yourself guiding high-stakes Go/No-Go moments and accelerating therapies to patients?Accountabilities:- Clinical Strategy Translation: Convert program strategy into high-quality study concept documents, protocols, and related materials (including ICFs, CRFs, TFL shells), ensuring alignment with clinical practice, the evolving scientific and regulatory landscape, and program objectives.- Protocol Ownership and Integrity: Be accountable for the scientific rationale and clinical integrity of protocols and clinical plan components; deliver final protocols and secure governance approvals, partnering with the Study Physician, GCPL, and GCH for technical reviews at bodies such as DRC and PRC; may lead and approve the Medical Oversight Plan.- Trial Delivery and Recruitment: Drive timely study initiation and execution with Clinical Operations, Program Management, GSTs, SMM, supply chain, and sample management; proactively flag recruitment risks, propose mitigations, and support implementation; provide clinical input to feasibility questionnaires and consult on country and site selection; respond rapidly to site queries and EC/IRB requests.- Safety and Medical Monitoring: May lead study-level medical monitoring and safety reviews to protect participants and data quality throughout study conduct.- Data Review and Decision-Making: Lead high-level clinical data reviews and interpretation; craft content for governance interactions seeking Go/No-Go decisions; lead development and delivery of the clinical study report.- Regulatory and Registration: Support health authority interactions; contribute clinical components for regulatory and EC/IRB submissions; provide clinical input to registration packages (e.g., NDA/BLA); collaborate on launch, branding materials, and publications.- External Engagement and Feasibility: Partner with investigators, KEEs, MSLs, and SMMs to optimize study design, feasibility, and recruitment strategies; contribute to advisory boards; develop and deliver investigator and monitor training.- Cross-Functional Leadership: Serve as a core GST member representing Clinical Development; embed cross-functional input from global medical affairs, marketing companies, commercial, and other stakeholders to unlock study success.- Process Improvement and Mentorship: Provide expert input or lead process improvements; contribute to cross-asset or cross-tumor working groups; mentor and develop less experienced team members and, as appropriate, provide line management.Essential Skills/Experience:- PharmD, Ph.D.

degree in life sciences, or MD preferred. Strong preference for Oncology experience- 7+ yrs Industry or academic experience in drug development required.- Possesses sound foundational knowledge of FDA and other major country regulations.- Possesses detailed knowledge of Good Clinical Practice (GCP) other regulations governing clinical research.- Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.- Significant oncology therapeutic experience to be sought out or serve as a resource to other internal/externalDesirable Skills/Experience:-