Clinical Program Lead (CPL) - RLT Focus
About The Position
The Clinical Program Lead (CPL) provides strategic medical guidance and leads the development of experimental oncology agents in the TCO portfolio, starting from Portfolio Entry/Drug Candidate (PE/DC) of preclinical development through the Transition Decision Point (TDP). This role requires providing strategic medical and scientific leadership to cross-functional project teams for new oncology agents, including small molecules, biologics, and radioligand therapies. The CPL is responsible for creating clinical development strategies, integrating preclinical data, and collaborating with various departments to optimize development plans. While registration studies are not directly managed, the CPL must establish an early clinical development strategy that supports subsequent registration trials. The role involves leading Biomedical Research Early Program Teams (BPTs) and potentially multiple global project teams, ensuring the safe, ethical, and efficient conduct of trials in compliance with Good Clinical Practice (GCP) and Novartis Standard Operating Procedures. The CPL will also interact with external experts, investigators, and regulatory authorities, and contribute to scientific publications.
Requirements
- MD or DO degree
- Fluent English – Oral and written
- At least 2 years of pharmaceutical/biotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center. If limited or no Pharmaceutical industry experience, then comparable senior academic experience in translational oncology and clinical research
- Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology)
- Strong knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials
- Proven ability to analyze and interpret efficacy and safety data relating to oncology
- Knowledge of GCP and world-wide regulatory requirements for clinical trials and oncology
- Excellent medical/scientific writing skills
- Successful track record of strategic thinking
- Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment
- Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
- Excellent written and oral English communication/presentation skills
- Strong office IT skills
Nice To Haves
- Board-certification in an oncology specialty and PhD-level science are preferred
- Experience within RLT preferred
- Recognized as an expert in your field by external medical experts. External candidates have a substantial record of publication and international recognition
Responsibilities
- Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DC.
- Creates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe, combining medical knowledge with expertise from other disciplines to optimize the strategy.
- Delivers solutions within functions, across functions, and on global projects, developing an independent approach to TCO strategy.
- Provides an early clinical development strategy that foresees and supports subsequent registration trials.
- Develops the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teams.
- Lead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP.
- May lead multiple global project teams.
- Integrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets implications for clinical development, as articulated in the Investigator’s Brochure and First-in-Human protocol.
- Collaborates with clinical scientists to develop clinical protocols for TCO compounds and develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).
- Applies own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility.
- Knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them.
- Liaises with outside experts, investigators, and regulatory authorities in oncology, and represents own projects to those groups and authorities.
- Writes and reviews abstracts/manuscripts etc. for presentation/publications at internal/external meetings.
- Participates in task forces to support continuous improvement and other management objectives.
- Operational responsibility for quality and compliance.
- May provide informal mentorship to less experienced CPLs.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- a variety of other benefits
- a generous time off package including vacation, personal days, holidays and other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
