Senior* Global Program Clinical Head – CRM

vor 1 Tag

Basel, Schweiz Healthcare Businesswomen’s Association Vollzeit

Job Description Summary

The (Senior) Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.
As the leader of Global Clinical Team(s) (GCT), the GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, market access and owns the risk benefit-assessment for the program(s). The GPCH contributes to the disease area strategy.

Job Description

Major accountabilities:

Your responsibilities include, but are not limited to:

  1. Leading the GCT and representing Clinical Development on the Global Program Team (GPT).
  2. Leading the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmaco-economic dossiers) with high quality and consistency with Integrated Development Plan (IDP) and Target Product Profile (TPP). Supports 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).
  3. May serve as the Clinical Development Representative on Biomedical Research clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP).
  4. Post-DDP, leading the development and execution of the clinical strategy. Developing an endorsed (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs.
  5. Where applicable, supporting Business Development & Licensing (BD&L) activities.

Minimum Requirements:

  1. MD or equivalent (preferred), PhD, or PharmD degree required, specialization in a subspecialty may be needed. Advanced clinical training/knowledge in disease area (Cardiology) preferred with 6 years (MD or equivalent).
  2. 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers.
  3. Advanced knowledge of assigned therapeutic area preferred, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data.
  4. 5 years people management experience required; this may include management in a matrix environment.
  5. Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process.
  6. Experience with submissions and health authorities required.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

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

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