Clinical Program Leader / Senior Clinical Program Leader, Translational Clinical Oncology (Dual Posting)

Role Summary

Clinical Program Leader / Senior Clinical Program Leader, Translational Clinical Oncology (Dual Posting) roles overseeing planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations to ensure safe, effective and innovative treatments reach patients quickly.

Responsibilities

• Provides strategic medical guidance for the development of new oncology agents in preclinical development, accountable for Translational Clinical Oncology (TCO) aspects of global drug development programs; establish and approve methods for design and implementation of clinical protocols, data collection systems and final reports.
• Evaluate external opportunities for potential business development.
• Create clinical development strategy for new oncology agents, integrating medical knowledge with input from Biomarkers, Clinical Pharmacology, Biostatistics, etc., to optimize development strategy and support subsequent registration trials.
• Lead Biomedical Research Program Teams (BPTs) from approval through GLP toxicology studies to enable clinical development; may lead multiple global project teams.
• Support ongoing clinical research and trials; ensure efficient processing of confidentiality and clinical agreements.
• Develop Integrated Development Plan (IDP).
• Integrate preclinical information and interpret implications for clinical development as described in Investigator‚Äôs Brochure and first-in-human protocol.
• Collaborate to develop clinical protocols and instruments (case report forms, analysis plans, clinical study reports) for TCO compounds.
• Apply medical knowledge to guide safe, ethical, and efficient trial conduct; ensure compliance with GCP and SOPs.
• liaise with outside experts, investigators, regulatory authorities; represent projects; foster communication with key opinion leaders; act as medical monitor; contribute to abstracts/manuscripts; participate in task forces; mentor and support CPLs in TCO.

Qualifications

• MD or DO with additional laboratory-based training; Board certification (or equivalent) in an Oncology sub-specialty.
• Working knowledge of PK/PD and biostatistics in clinical development and trials.
• Proven ability to analyze and interpret oncology efficacy and safety data; knowledge of GCP and global regulatory requirements.
• Excellent medical/scientific writing and oral communication skills.
• Proven ability to manage and develop a team; experience across multiple indications; strong teamwork; creative, independent leadership; ability to design PoC studies and think critically; ethical integrity and commitment to patient outcomes.
• Inspires others and demonstrates passion for translational science.

Desirable Qualifications

• Experience from an academic medical center.
• PhD.

Skills

• Strategic medical guidance; clinical protocol development; cross-disciplinary collaboration; medical monitoring of global studies.
• Strong writing, presentation, and interpersonal communication.

Education

• MD or DO; Board certification in Oncology sub-specialty; additional research training (preferred).

Additional Requirements

• Location: Cambridge, MA; domestic and international travel ~10%.
• Dual posting; final title/level determined by hiring team (Clinical Program Leader or Senior Clinical Program Leader).