Global Program Clinical Head - CVM - Lipids Job ID REQ-10035867
Jan 29, 2025
USA
Summary The Global Program Clinical Head (GPCH) in CVM - Lipids 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.
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 NIBR 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) 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) with high quality and consistency with IDP and TPP.
Supports registration, market access, commercialization, and maintenance of product licenses.
Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
As the medical expert, leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders) and internal stakeholders (e.g., Research, Global Medical Affairs, Marketing).
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.
Cardiovascular disease expertise.
Advanced knowledge of assigned therapeutic area required.
Thorough knowledge of Good Clinical Practice, clinical trial design, and regulatory/clinical development process required.
Experience with submissions and health authorities required.
Demonstrated ability to establish strong scientific partnerships with key stakeholders.
Demonstrated leadership and management skills with a documented track record in pharmaceutical or biotech industry.
* Final job title (Senior GPCH, Level 7 / GPCH, Level 7) and associated responsibilities will be commensurate with the successful candidates’ level of expertise.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $261,100/year to $484,900/year. Final pay determinations will depend on various factors, including geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.
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The Novartis Group of Companies are Equal Opportunity Employers.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
Division Development
Business Unit Innovative Medicines
Location USA
State New Jersey
Site East Hanover
Company / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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