Global Program Clinical Head

Novartis; Greater London; Hybrid; GBP 150,000 - 200,000; Full time

Job summary

A global pharmaceutical leader is seeking a Global Program Clinical Head to lead clinical programs involving multiple compounds. The role requires strong experience in clinical research, particularly in cardiovascular disease, and leadership in developing strategies for successful regulatory submissions. Candidates should have a medical degree alongside significant industry experience, with responsibilities including overseeing clinical trials, managing drug safety evaluations, and engaging with various stakeholders. This position is based in London or Basel.

Benefits

Diversity and Inclusion commitment

Comprehensive benefits package

Qualifications

• 6 years professional experience with MD or equivalent in clinical research.
• 10 years experience with PhD or PharmD in drug development.
• Cardiovascular disease expertise required.
• Thorough knowledge of Good Clinical Practice and regulatory processes.

Responsibilities

• Lead Global Clinical Team and represent Clinical Development.
• Drive transition of projects to Development Decision Point.
• Develop Integrated Development Plan for regulatory approval.
• Ensure continuous evaluation of drug safety profile.

Skills

Budget Management

Clinical Trials

Leadership

Risk Management

Strategy

Education

MD or equivalent (preferred)

PhD or PharmD degree

Tools

Microsoft Project

Microsoft Powerpoint

Job description

Job Description Summary

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

Job Description

This role can be based in London or Basel.

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) Investigators 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.

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
• Cardiovascular disease expertise ideally experience with Cardio‑Immunology or inflammasome
• 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

Why Novartis

Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here: Desired

• Budget Management
• Clinical Trials
• Coaching
• Compliance
• Cross‑Functional Teams
• Leadership
• People Management
• Risk Management
• Risk Monitoring
• Strategy

• Project Management Methodology
• Project / Program Management
• Program Management
• Management Experience
• Microsoft Powerpoint
• Project Management
• Microsoft Project
• Budgeting
• DoD Experience
• Leadership Experience
• Supervising ExperienceContracts

Employment Type : Full-Time

Experience: years

Vacancy: 1

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Global Clinical Head • London, England, UK