Global Program Clinical Head - Rheumatology/Gastroenterology

Innovative Medicines
London

Summary

Leads the strategic planning, execution, and delivery of all global clinical trials across all programs within the assigned TA. Complete oversight of budget and resource allocation within the therapeutic area – including enterprise review of resources across the TAs. Drives operational excellence through process improvement and knowledge sharing across the function. Develops an empowered organization which can navigate in a matrix environment and adjust quickly to business needs.

About the Role

This hybrid role can be based in London, Basel, Dublin or Barcelona.

Major accountabilities:

  • Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
  • 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)
  • May support Business Development & Licensing (BD&L) activities Post-DDP, leads the development and execution of the clinical strategy.
  • Develops an endorsed Integrated Development Plan (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
  • Leads 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, pharmacoeconomic dossiers) with high quality and consistency with IDP and 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)
  • Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team (SMT)
  • As the medical expert, leads 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 (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards.

Minimum requirements:

What you’ll bring to the role:

  • MD or equivalent (preferred) PhD, or PharmD degree required
  • 6 years professional experience with (MD or equivalent) OR 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 required
  • Immunology disease expertise, ideally experience with Rheumatology / Gastroenterology
  • Advanced knowledge of assigned therapeutic area required, 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
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process required
  • Experience with submissions and health authorities required
  • 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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

R ead our handbook to learn about all the ways we’ll help you thrive personally and professionally:

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

#LI - hybrid

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

Posted 2025-09-10

Recommended Jobs

Immigration Paralegal

Gemini Recruitment
London

Role:  Immigration Paralegal Leading law firm looking to recruit dedicated Immigration Paralegal for highly sought permanent position. Gemini Recruitment are currently partnering with a large …

View Details
Posted 2025-09-24

Exceptional opportunity for an Employment Tax Specialist

Capital Tax Recruitment
London

Are you ready to join one of the world's largest networks of audit, tax, and consulting firms and contribute to the success of middle-market businesses? Our client is a fast-growing firm with a clear…

View Details
Posted 2025-09-10

Assistant Project Manager

The Highfield Company
London

Role: Junior / Assistant Project Manager Location: Heathrow Airport base Salary: Up to £60,000 Are you eager to kick-start your career in the dynamic world of structural steel project? Our c…

View Details
Posted 2025-09-24

Analytics & Insight Lead (IT)

VIQU IT
London

Analytics & Insight Lead London or Horsham – Hybrid Up to £90,000 + Bonus VIQU have partnered with a leading organisation who are seeking an Analytics & Insight Lead to shape and deliver thei…

View Details
Posted 2025-09-24

Patient Centered Outcomes HTA, TA Director (4 open roles)

Universal Hierarchy Node
London

Summary As part of International HEOR & PCO in International Value & Access, the Patient Centered Outcomes (PCO) HTA, TA Director within the HEOR TA teams, in partnership with HEOR leads …

View Details
Posted 2025-09-11

Real Estate Solicitor 5-7yrs PQE

QED Legal
London

Real Estate Solicitor 5-7yrs PQE in London.  International Law firm.  You will handle commercial real estate investment and asset management matters and provide support on larger real estate finan…

View Details
Posted 2025-09-24

Dog Walking needed near Oval SW8

Tailster
Oval, Greater London

Hello, looking for someone that has an unconventional love for dogs, highly responsible. Our dog has a bit of anxiety issues and want someone that help him with this. He’s very affectionate once he st…

View Details
Posted 2025-09-10

IT Support Engineer

Stratford, Greater London

IT Support Engineer ðŸ" Glasgow, G32 9AT ðŸ'° up to £28,800 per annum depending on experience ðŸ"... Full-time Would you like to make a real difference and deliver projects that will impact the live…

View Details
Posted 2025-09-13

Engineering - Platform Engineer - Analyst/Associate - London

Goldman Sachs
London

Goldman Sachs is a leading global investment banking, securities and investment management firm that provides a wide range of services worldwide to a substantial and diversified client base that inc…

View Details
Posted 2025-09-10

Senior National Account Manager

The Advocate Group
London

Senior National Account Manager (Grocery) – Top 5 Spirits Producer Field-Based | Competitive Salary & Package This is an exciting opportunity to join a global premium spirits business with a por…

View Details
Posted 2025-09-12