As Global Program Clinical Head (GPCH), you are the clinical lead of a Oncology full development product and will lead the clinical assessment of internal Biomedical Research (BR) early clinical programs and external assets (Business Development & Licensing - BD&L) across Oncology (Solid Tumor) indications. As a key member of the Global Program Team, you will contribute to the overall strategy in collaboration with relevant other functions such as Regulatory Affairs, Market Access and others. You will develop and ensure the implementation of the Clinical Development plan and lead a cross-functional team of specialists such as Medical Directors, Trial Directors, Safety Leaders, Biostatisticians and Regulatory Directors. In addition, you will lead the development and execution of the disease area strategy.
About the Role
Your Key Responsibilities:
- Responsible for clinical input to support Business Development & Licensing (BD&L) activities
- Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
- Contribute to Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) designed for successful global regulatory approval/market access for one or more treatment indications and/or multiple programs.
- Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s).
- Lead a cross-functional team through the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency.
- As the medical expert, lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research), and internal decision boards.
- Together with Patient Safety, ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
- Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)
- Plan and implement publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing and provide input into key external presentations.
Role Requirements:
- MD, PharmD, PHD degree with 6+ years’ experience in clinical research or drug development in an industry environment spanning clinical activities in Phases I-III/IV, including submission dossiers.
- A passion for Oncology
- Advanced expertise in Oncology with ability to innovate in clinical development study designs, provide relevant evidence to decision-makers and to interpret, discuss and present clinical trial or section program level data
- Detailed knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
- Demonstrated ability to establish strong scientific partnership with key stakeholders
- Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
- MD license is highly preferred and desirable.
This is a hybrid role, based at The Westworks in London
Commitment to Diversity & Inclusion:The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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