Résumé
About the Role
Major accountabilities:
Your responsibilities include, but are not limited to:
In alignment with the Head of CD Advanced Clinical Methods and CoE, leads the multi-stakeholder Pediatric Clinical Group, its structure, resources, processes, and implementation plan, as a focal point for pediatric expert knowledge development, expert advisory body, and dissemination of best practices/shared learnings/peds curriculum.
In concert with Early Phase-Global Program head (EP-GPH), identifies early programs/indications with potential pediatric use to ensure pediatric programs are prepared for regulatory requirements and to reduce cycle times for pediatric development to make important drugs available efficiently and expeditiously. These activities would coincide with early portfolio tollgates.
Leads the development of the pediatric clinical strategy in partnership with the Global Clinical Program Head (GPCH) to ensure efficient parallel development is feasible. Develops an endorsed pediatric plan within the Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access/Compliance Check for one or multiple treatment indications and/or multiple programs
Leads the Pediatric Sub-team within the GCT for priority programs, represents the pediatric Clinical Development on the (early) Global Program Team (GPT)
Leads the strategy behind key pediatric clinical components of key documents (CTP, regulatory documents including PIP(s), IPSP (s), and WR(s) with high quality and consistency with CDP and TPP in collaboration with clinical team.
Provides oversight of processes for review through ISRC (protocol review committee or equivalent), infrastructure, resources, capabilities, and culture to facilitate all teams to plan early, design innovative and efficient, feasible pediatric studies and deliver quality pediatric clinical trials on realistic timelines. Provides directly, or through the Pediatric Clinical Group support to GPTs in developing sound pediatric regulatory plans and responses to feedback/discussions with revelant Authorities.
Accountable for oversight related to direct Pediatic Clinical Group support staff including performance management process, annual objectives and performance appraisals for functional direct reports as required. Ensure efficient on-boarding, training, and mentoring of new associates, and mini-sabbaticals within pediatrics.
Serves as an internal scientific and clinical consultant in his/her areas of specialization
Customer facing representation of Novartis to the relevant scientific, academic, and patient advocacy groups. Develops and maintains key external relationships with academia, health authorities, trade organizations and other stakeholders. Writes review articles and publications in collaboration with academic researchers.
May attend and present at key HA-related meetings per team request. Provides expert contributions to Franchise Strategic Plan in collaboration with other members of the CD team.
Leverages knowledge, expertise, understanding of external stakeholders, internal team capabilities and portfolio needs to develop a compelling innovative vision and strategy for the program/portfolio and subsequent impact on overall Development and Pharma strategy
As the medical expert, may lead interactions with external stakeholders (e.g., key opinion leaders, DMC’s, advisory boards, patient advocacy groups) internal stakeholders and internal decision boards.
Key contributor to CD organization including CDP/IDP reviews, development and implementation of clinical development and support the Peds CoE in talent management and peer review in areas of expertise
Proactively shape the external environment to defend and improve Novartis position relevant to the project by development strong evidence and trust-based relationship with key stakeholders (e.g., KOL, patient groups, scientific societies, global pediatric networks)
What you'll bring to the role:
MD or MD/PhD required with advanced knowledge and clinical training in a pediatrics with advanced training in sub-specialty) preferred. Medical Board certification required; Clinical practice experience ≥ 6 years (including completion of medical residency/fellowship) required
Fluent oral and written English
Min 10 years of drug development or relevant clinical research experience
Proven track record of R&D leadership and management
Clinical background relevant to the pediatric programs in Development Franchises
Experience in product registration and major Health Authority interactions preferred
Considerable organizational awareness including significant experience working cross-functionally and in global teams
Excellent communication skills, written and oral
Strong interpersonal skills
Excellent negotiation and diplomatic skills, experience with submissions and health authorities required
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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 & 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.
![A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment. A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.](/themes/custom/polaris/patterns/images/careers-default-image.webp)