Global Program Clinical Head - Rheumatology/Gastroenterology
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:
Recommended Jobs
Science Teacher - Biology Specialist - Waltham Forest
Science Teacher – Elevate Practical Biology Skills and Lead KS5 Curriculum in a Supportive Faculty – Waltham Forest A dynamic and supportive secondary school in Waltham Forest is recruiting an e…
Primary School Tutor Wanted - Remote, No Experience Required
We are currently seeking a dynamic and innovative private tutor to join our exceptional team of educators in the UK. We are specifically looking for a qualified teacher to become an integral part of o…
Platform Engineer
Platform Engineer (Permanent) Salary: £65,000 - £75,000 Location: Flexible (UK-based) iO Associates are supporting a large public-sector organisation. They are building a new engineering ser…
Part-time Nanny-Housekeeper, Job ID J1E7B0
A lovely family based in Lewisham, London, is looking for a Part-time Nanny-Housekeeper to care for their school-aged child while keeping their home clean and tidy. The role includes school pick-up d…
Field Solutions Architect, Generative AI, Google Cloud
Minimum qualifications: ~ Bachelor's degree in Computer Science, Data Science, or equivalent practical experience. ~7 years of experience working in AI/ML as a technical sales engineer or in soft…
Qualified Social Worker, CP/CIN
Qualified Social Worker, CP/CIN Pay rate up to £34.50 per hour Contract role, We are recruiting for an experienced Social Worker to work in a Child Protection/Child in Need Team in Enfield. …
Sales/Client Advisor - London
Founded in 2023 our client has quickly established itself as a trailblazer in the world of niche fragrance. Combining imaginative scent storytelling with a meditative and creative approach, they offer…
Freelance Creative Director
We’re looking for a Freelance Creative Director with deep experience in branding and visual identity development to lead the creative vision for our company. This role requires a strategic think…
UK/ US Tax Director
A leading consulting firm is looking for a US/UK Tax Director to join their PCS team. Specifically, you'd help lead the firm's Entrepreneurial Private Wealth (EPW) team, collaborating with HNWIs. …