Global Development Scientist, Associate Director

Global Development Scientist, Associate Director

Waltham, MA / Boston, MA

Introduction to role:
Are you ready to shape the clinical strategy that accelerates transformative immunotherapy and cell therapy for blood cancers from concept to global registration? This role places you at the heart of a combination-focused pipeline, leveraging six scientific platforms to address urgent unmet needs in hematologic malignancies.

You will work at the intersection of clinical science and execution—translating strategy into robust protocols, guiding data-driven decisions, and ensuring trials deliver meaningful outcomes for patients and regulators. Partnering with clinicians, translational scientists, statisticians, operations, and regulatory experts, you will move novel therapies through development with speed, rigor, and clarity.

Can you see yourself turning complex clinical evidence into decisions that redefine standards of care? Join a team that prizes bold thinking, scientific depth, and crisp delivery to bring life-changing medicines to patients who need them most.

Accountabilities:

• Clinical Strategy to Protocol:
  Convert clinical strategy into study concept documents, protocols, and related materials; secure governance approval and maintain scientific integrity throughout.
• Trial Design and Delivery:
  Design and implement clinical trials, including studies involving immunotherapy and cell therapy approaches; assure quality conduct, timely delivery, and alignment with registration pathways.
• Scientific Leadership:
  Own the relevance and accuracy of the clinical science underpinning each study through deep literature assessment, expert consultation, and continuous data-driven refinement.
• Data Review and Interpretation:
  Lead clinical data review and cleaning; synthesize emerging evidence with the Medical Director to drive clear, actionable conclusions and next-step decisions.
• Regulatory Readiness:
  Prepare and contribute clinical content for CSRs and regulatory documents (e.g., IB, DSUR, PSUR, NDA/BLA responses), enabling successful global submissions and inspections.
• Cross-Functional Program Leadership:
  Lead or contribute as a technical expert to cross-functional projects advancing assets through all phases of development, from early signals to pivotal registration.
• External and Site Engagement:
  Build strong relationships with regulatory bodies and service providers; provide timely, high-quality responses to study sites on ICF updates, protocol clarifications, and EC/IRB queries.
• Investigator and Team Training:
  Develop and deliver engaging investigator meetings and internal training, ensuring consistent understanding of study intent, endpoints, safety, and data expectations.
• Opportunity Assessment:
  Participate in or lead evaluations of new opportunities and externally sponsored research to shape future portfolio decisions and collaborations.

Essential Skills/

Experience:

• BS required
• Minimum of 3 years of relevant experience
• Industry or Academic experience in drug development required with experience in malignant haematology clinical trials strongly preferred.
• Sufficient technical knowledge (haemato-oncology background preferred) to be able to interact with confidence with internal and external partner
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research.
• Ability to drive/contribute to protocol design, writing and implementation

Desirable Skills/

Experience:

• Advanced degree (MS, PhD, PharmD, MD) in a relevant scientific or clinical discipline
• Direct experience with immunotherapy and/or cell therapy trials in hematologic malignancies
• Hands-on involvement in NDA/BLA or equivalent global submissions
• Familiarity with translational biomarkers, novel endpoints, and innovative trial designs
• Experience with global, multicenter studies and vendor oversight
• Strong publication record and scientific communication skills
• Proficiency in data-driven review methodologies and cross-functional decision forums

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.…