Global Program Clinical Head, Early Projects Job ID REQ-10037341
Jan 24, 2025
USA
Summary The Global Program Clinical Head (GPCH) for Cardiovascular early development projects and licensing is the global clinical leader responsible for working with Research and Translational Medicine across indications and involving multiple compounds. The GPCH works to ensure early development plans and proof of concept studies are aligned with Development strategy and leads licensing evaluations for Clinical Development for the therapeutic area.
About the Role Major accountabilities:
Serve as the Clinical Development Representative on Biomedical Research (BR) clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP).
Supports Business Development & Licensing (BD&L) activities.
Leads the GCT, represents Clinical Development on the Global Program Team (GPT).
Post-Transition Development Point, 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 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 Qualifications MD or equivalent (preferred), or PharmD, PhD.
6 years professional experience with MD or equivalent or 10 years with PharmD or PhD 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.
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.
Compensation and Benefits The pay range for this position at commencement of employment is expected to be between: $261,100/year to $484,900/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to 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 in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
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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