Global Program Clinical Head
Global Program Clinical Head
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$ 261100 - 484900
1 Vacancy
Job Description
Band
Level 7Job Description Summary
-Designs and provides oversight of clinical research programs. Builds relationships with key opinion leaders and applies their input to enhance study design and protocols. Serves as medical/scientific consultant to marketing or research project teams and government regulatory agencies. Establishes the criterion essential for determining the safety efficacy and medical utilities. Interprets results of Phase I-III investigations in preparation for new-drug or medical device application. May serve as safety expert for individual clinical projects. May be responsible for post marketing studiesJob Description
Major accountabilities:
Serves 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) 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.
Minimum Requirements:
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
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $261100/year to $484900/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market maynecessitateadjustments to pay ranges during this final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and 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. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right tomodifybase salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Clinical Decision Making Clinical Research Clinical Trials Disease Area Knowledge Drug Development Leadership People Management Risk Management Strategy DevelopmentRequired Experience:
Exec
Employment Type
Full-Time
