Global Program Clinical Head - Cardio Immunology

Novartis Farmacéutica; Basel-Stadt; Vor Ort; CHF 160’000 - 200’000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Global Program Clinical Head to oversee the clinical development programs in cardiovascular diseases. The ideal candidate will have an MD or equivalent, significant experience in clinical research, and expertise in the cardiovascular field. The position offers an opportunity to contribute to innovative projects aimed at improving patient outcomes in a diverse and inclusive environment.

Qualifikationen

• 6+ years experience with MD or equivalent, or 10 years with PhD/PharmD in clinical research.
• Advanced knowledge of assigned therapeutic area.
• Thorough understanding of Good Clinical Practice.

Aufgaben

• Leads Global Clinical Teams and oversees clinical programs.
• Develops Integrated Development Plan for regulatory approvals.
• Leads interactions with regulatory authorities and key stakeholders.

Kenntnisse

Leadership

Clinical Trial Design

Regulatory Knowledge

Cardiovascular Disease Expertise

Stakeholder Engagement

Ausbildung

MD or equivalent, PhD, or PharmD degree

Jobbeschreibung

Job ID REQ-10054112

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

About the Role

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.

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 people’s 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: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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: https://talentnetwork.novartis.com/network

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? https://www.novartis.com/about/strategy/people-and-culture

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: https://talentnetwork.novartis.com/network

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

Job ID REQ-10054112