Executive Clinical Program Leader - Translational Clinical Oncology

Job Description Summary

About the role : #LI-Onsite

To provide strategic, medical and scientific guidance and leadership for the development of multiple experimental agents in the Translational Clinical Oncology (TCO) portfolio beginning with input to early Target identification and continuing through to the Transition Decision Point. Formulate actionable development plans with the Development Organization to ensure rapid and seamless decision making and transitions of portfolio molecules and other assets. Provide scientific and clinical leadership to inform potential external innovative programs and business development in strategic areas of focus for the company.

Job Description

Key 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.

Essential Requirements :

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.

The salary for this position is expected to range between $261,100 and $484,900 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$261,100.00 - $484,900.00

Skills Desired

Clinical Decision Making, Clinical Research, Clinical Trials, Disease Area Knowledge, Drug Development, Leadership, People Management, Risk Management, Strategy Development