Head Cd Pediatric Coe

4 weeks ago

East Hanover, United States Novartis Full time

**Summary**:
When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Head Clinical Development, Pediatric COE. The Head of Pediatric Development is the functional leader of the Pediatric Clinical Group with responsibility to raise awareness, strategy, and skills to enhance Pediatric Drug Development across all Therapeutic Areas; in particular educate the Global Program Teams (GPTs) to drive integrated partnership between research, clinical and operations to enable early planning for most efficient, strategic and feasible development of pediatric projects. You will be responsible for the implementation of the cross-functional Pediatric organization to provide expert clinical and strategic advice, shared learnings, educational tools/resources to Development and Biomedical Research (BR) global teams pursuing pediatric drug development across the entire Novartis portfolio and to realize a culture change to optimize our Pediatric obligations and opportunities. This role is a a key contact with major external stakeholders and non-governmental stakeholders including academic societies and institutions, governmental and non-governmental agencies, key opinion leaders, clinical networks, and patient advocacy groups. You may consult across multiple franchises, as needed, based on therapeutic or scientific expertise, and may also be required to represent Novartis externally to key stakeholders including scientific societies, academic groups, and global regulatory authorities.

**About the Role**:
**Major accountabilities**:
Your responsibilities include, but are not limited to:

- In alignment with the Head of Clinical Development Advanced Clinical Methods, 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.
- With the 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 creation of clinical components of key documents.
- Provides oversight of processes for review through ISRC, 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.
- Customer facing representation of Novartis to the relevant scientific, academic, governmental, and patient advocacy groups.
- Attends and presents at key regulatory meetings. Provides expert contributions to Franchise Strategic Plan in collaboration with other members of the CD&A team.
- 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.

What you'll bring to the role:

- MD or MD/PhD required with advanced knowledge and clinical training in a pediatrics is preferred. Medical Board certification required; Clinical practice experience 6 years (including completion of medical residency/fellowship) required.
- 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 comm

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