Head CD Pediatric CoE

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 communication skills, written and oral

• Strong interpersonal skills

• Excellent negotiation and diplomatic skills, experience with submissions and health authorities required