Clinical Scientist - Oncology

Clinical Scientist (Cambridge/Boston, MA)
Objectives

• Represent, and may lead, clinical science for regional (US or other region) clinical development of assigned pipeline compounds.
• Lead a multidisciplinary, matrixed team; ensure scientific issues are considered for complex data.
• Influence creation, maintenance, and execution of a clinical development plan to support regulatory approval across multiple regions.

• Participate and lead clinical development teams; align US/EU activities with global strategy.
• Develop program deliverables:
  Development Strategy, Clinical Development Plan sections, and Clinical Protocols.
• Recommend program scope/complexity and influence budget.
• Critically evaluate and maintain state-of-the‑art development strategy; identify challenges and contingency plans.
• Monitor and interpret internal/external study data; support high‑impact global/regional decisions (e.g., go/no go; protocol/design modifications).
• Create and secure governance approval for synopsis/protocol development, study execution, and study interpretation.
• Lead protocol synopsis completion and obtain review committee approvals; manage IRB/Ethics documentation responses; review/interprete study data and communicate conclusions.

• Manage information for protocol conduct and subject safety; provide preliminary assessments to Medical Monitor.
• Review overall safety data with Pharmacovigilance and Medical Monitor of record.

• Contribute to regulatory/KOL interactions; develop company positions for briefing reports, presentations, and formal responses.
• Incorporate external advice/recommendations into clinical study/program design.

• BS with 6 yrs; MS with 4 yrs;
  PharmD with 2 yrs; or PhD with 1 yr clinical research/clinical development experience (pharma/CRO/academia).
• Strong communication, strategic, interpersonal, negotiating skills.
• Clear concise communication; proactive issue prediction and problem-solving.
• Ability to drive decisions in multidisciplinary, multi‑regional matrix teams; diplomacy and influencing.
• Therapeutic area knowledge (mechanism of action), regulatory requirements, GCP/ICH; emerging research knowledge.

• Medical, dental, vision; 401(k) with match; disability; life insurance; tuition reimbursement; paid volunteer time off; company holidays; well‑being benefits; up to 80 hours/year sick time; up to 120 hours paid vacation for new hires.