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Executive Clinical Program Leader - Translational Clinical Oncology

Novartis
Full-time
On-site
Cambridge, MA
$261,100 - $484,900 USD yearly
Clinical Research and Development

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Role Summary

Executive Clinical Program Leader - Translational Clinical Oncology leads strategic medical and scientific guidance for the development of multiple experimental agents in the Translational Clinical Oncology portfolio, from early target identification through Transition Decision Point. Develop actionable development plans with the Development Organization to enable rapid decision making and transitions, and provide clinical leadership to inform external innovative programs and business development in strategic areas.

Responsibilities

  • Serve as an Early Clinical Development Area Leader for TCO, overseeing innovative clinical strategies for multiple molecules/assets advancing in strategic indications, ensuring robust development plans are in place and executed.
  • Mentor physicians (direct reports and others) to ensure programs align with oncology strategy and support their career development.
  • Represent TCO programs and strategy at governance boards and across the organization.
  • Provide senior leadership and clinical input to clinical studies and pre-clinical research, integrating medical knowledge with other disciplines to optimize development strategy, including supporting subsequent registration trials.
  • Critically review and provide feedback on program documents (protocols, IBs, health authority responses).
  • Provide strategic input on internal and external assets, representing TCO in BD&L due diligence and integrations.
  • Lead or oversee external collaborations, partnering with colleagues across the company.
  • Contribute strategic advice in early development committees and initiatives (e.g., Study Concept Review Board, Protocol Review Committee).
  • Mentor and serve as an educational resource within BR and across the organization.
  • Apply medical knowledge to guide safe, ethical, and efficient conduct of trials.
  • Maintain or exceed compliance with Good Clinical Practice guidelines and internal SOPs.
  • Liaise with outside experts, investigators, and regulatory authorities in FIH oncology trials and represent projects to these groups.
  • Write and review abstracts/manuscripts for presentation/publication at internal/external meetings.

Qualifications

  • MD degree and PhD-level basic science required; MD/PhD preferred. Board-certification in Hematology-Oncology (heme-onc) or equivalent expertise.
  • 7+ years of experience leading complex global early-phase hematology-oncology clinical programs in pharma/biotech, plus credible academic medical center experience; or substantial translational hematology/oncology experience with clinical trial work.
  • Recognized as a Heme-Onc expert with a strong record of quality publications and international recognition.
  • Experience interpreting preclinical data in hematology/oncology (molecular biology, pharmacology, PK/PD, toxicology).
  • 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 for clinical trials and oncology.
  • Excellent medical/scientific writing and oral communication skills.
  • Proven ability to manage and develop a team; strong mentorship and leadership qualities.
  • High ethical integrity and commitment to improving outcomes for patients with malignancies.

Skills

  • Strategic clinical development leadership
  • Clinical trial design and execution in hematology-oncology
  • Cross-functional collaboration and stakeholder management
  • Scientific writing and presentation
  • Mentorship and team development
  • Regulatory engagement and health authority interactions

Education

  • MD required; PhD preferred
  • Board-certification in Hematology-Oncology or equivalent

Additional Requirements

  • Location: Cambridge, MA; not remote. 20-25% travel domestically and/or internationally.