Executive Clinical Program Leader - Translational Clinical Oncology

Role Summary

Executive Clinical Program Leader - Translational Clinical Oncology

Responsibilities

• Serve as an Early Clinical Development Area Leader for TCO, overseeing and implementing innovative clinical strategies for multiple molecules/assets that are advancing clinical testing in strategic indications, ensuring that robust and comprehensive development plans are in place and implemented.
• Oversee physicians (including direct reports and others) with strong mentorship and attention to ensure the strategic and operational aspects of their programs align with the overall oncology strategy and to foster their career development.
• Represent TCO programs and program strategy at governance boards in Biomedical Research (BR) (e.g., TCO-Leadership Team (LT), Integrated Cancer Decision Board (ICDB), Discovery & Translational Board (DTB) and across the organization (e.g., Oncology Development Unit (ODU-LT), Therapeutic Area Leadership Team (TAL).
• Provide senior leadership and clinical input to clinical studies and pre-clinical research projects under their responsibility, effectively integrating their medical knowledge with expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy, including supporting subsequent registration trials.
• Critically review and provide constructive feedback on documents for programs and studies under supervision including but not limited to protocol, Investigators Brochures (IBs), and health authority responses.
• Provide strategic input on internal and external assets and portfolio areas, representing TCO in Business Development and Licensing due diligence reviews and integrations.
• Lead or help oversee external collaborations, partnering closely with colleagues across the company.
• Play leadership roles in early development committees and initiatives by actively contributing strategic advice (e.g., the Study Concept Review Board and Protocol Review Committee).
• Mentor and serve as an educational resource and expert within BR and across the organization.
• Apply medical knowledge to guide the safe, ethical and efficient conduct of own trials.
• Strive to maintain or exceed compliance obligations for Good Clinical Practice guidelines and Novartis Standard Operating Procedures.
• Liaise with outside experts, investigators, and regulatory authorities in oncology early clinical development First in Human (FIH) trials and represent projects to those groups and authorities.
• Write and review abstracts/manuscripts for presentation/publications at internal/external meetings.

Qualifications

• This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require 20-25% travel as defined by the business (domestic and/ or international).
• MD degree and PhD-level basic science required (PhD not required). MD / PhD preferred. Board-certification (or equivalent expertise) in Hematology-Oncology (heme-onc).
• 7+ years of experience leading complex global early phase hematology-oncology clinical programs from the pharma/biotech industry plus credible experience from an academic medical center. In case of no industry experience, substantially longer academic experience in translational hematology/oncology and substantial clinical study experience.
• Recognized as a Heme-Onc expert with a substantial record of quality scientific publications and international recognition for expertise.
• Interpretation of preclinical data in hematology/oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology).
• Working knowledge of the application of PharmacoKinetics (PK) / PharmacoDynamics (PD) and biostatistics to clinical development and trials.
• Proven ability to analyze and interpret efficacy and safety data relating to oncology.
• Knowledge of Good Clinical Practices (GCP) and world-wide regulatory requirements relating to clinical trials and oncology.
• Excellent medical/scientific writing and oral communication/presentation skills.
• Proven ability to manage and develop a team.
• Outstanding scientific mentor; inspires others.
• Excellent personal ethical integrity and commitment to improving outcomes for patients with malignancies.

Education

• No additional education section provided.