Home
/
Comprehensive
/
Global Program Clinical Head
Global Program Clinical Head-April 2024
East Hanover
Apr 16, 2025
About Global Program Clinical Head

Job Description Summary

The (Senior)* Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.

As the leader of Global Clinical Team(s) (GCT), the GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, market access and owns the risk benefit-assessment for the program(s). The GCPH contributes to the disease area strategy.Job Description

Major accountabilities:

Your responsibilities include, but are not limited to:

* Leading the GCT and representing Clinical Development on the Global Program Team (GPT)

* Leading 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, pharmaco-economic dossiers) with high quality and consistency with Integrated Development Plan (IDP) and Target Product Profile (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)

* 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)

* Post-DDP, leading the development and execution of the clinical strategy. Developing an endorsed (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

* Where applicable, supporting Business Development & Licensing (BD&L) activities

Minimum Requirements:

* MD or equivalent (preferred), PhD, or PharmD degree required, specialization in a subspecialty may be needed.

Advanced clinical training/knowledge in disease area (Cardiology) preferred with 6 years (MD or equivalent)

* 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

* Advanced knowledge of assigned therapeutic area preferred, 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

* 5 years people management experience required; this may include management in a matrix environment

* Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process

* Experience with submissions and health authorities required.

* 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; 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. 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 to modify base 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.

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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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 to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$261,100.00 - $484,900.00Skills Desired

Clinical Decision Making, Clinical Research, Clinical Trials, Disease Area Knowledge, Drug Development, Leadership, People Management, Risk Management, Strategy DevelopmentThe Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Comments
Welcome to zdrecruit comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
SIMILAR JOBS
Respiratory Therapist - Sioux Falls
General job duties. Types of procedures required.Nebulizers/inhalers, volurex, oxygen therapy/titration, protocols, airway clearance, trach changes, ventilators, BiPAP/CPAP, overnight oximetry. Equip
Maintenance Technician
MAINTENANCE TECHNICIANS NEEDED!! STARTING PAY $28 - 34/HR! An expanding company located in Portage, IN is seeking multiple maintenance technicians to join their team. Previous experience troubleshoot
EEG Technologist
Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are
Research Assistant, Health
Overview Join AIR as a Research Assistant with ourHealth (https://www.air.org/our-work/health) team. Our Health team works collaboratively to unravel the intertwined challenges of health care quality
Principal Software Developer
Job Description Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. As a member of the software engineering division, you will take an active r
F135 Forecasting: Forecast Modeler/Analyst (Remote)
Date Posted: 2024-01-15 Country: United States of America Location: PW208: Connecticut Remote Remote Location , Remote City, CT, 06035 USA Position Role Type: Remote Pratt & Whitney is working to
Software Engineer
The Lead Performance Engineer will be responsible for scaling the GuestXP team’s load and performance capabilities across 10 software delivering product teams. They will work with architects and engi
Pharmacy Technician
Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced
Restaurant Supervisor-Peruvian Japanese Specialty Restaurant- Marriott Resort Palm Jumeirah
Job Number 24012242 Job Category Food and Beverage & Culinary Location Marriott Resort Palm Jumeirah Dubai, Palm West Beach Palm Jumeirah Road, Dubai, 0, United Arab Emirates Schedule Full-Time L
MANAGER OF STRATEGIC PARTNERSHIPS AND GOVERNMENT AFFAIRS (MANAGER OF GOVERNMENT AFFAIRS)
MANAGER OF STRATEGIC PARTNERSHIPS AND GOVERNMENT AFFAIRS (MANAGER OF GOVERNMENT AFFAIRS) Print (https://www.governmentjobs.com/careers/longbeach/jobs/newprint/4354572) Apply  MANAGER OF STRATEGIC PA
Copyright 2023-2025 - www.zdrecruit.com All Rights Reserved