US-NJ, Global Program Medical Director (Pediatrics) 201846BR-MZ
Global Program Medical Director (Pediatrics)
Global Drug Development
Global Develop NPH
East Hanover, NJ
Research & Development
The Global Program Medical Director (GPMD) is responsible for the scientific and medical strategy of Pediatric TA to support from early PoC efforts into late transition of clinical pediatric development programs (e.g., indication selection, patient considerations, new formulation, or specific development phase). Responsible as a key pediatric expert to advise teams on early considerations in design, implementation, and strategy for pediatric studies with focus on those in Clinical Development to support decision milestones, study preparation/delivery, integrated global pediatric plans (GPP) and efforts leading to regulatory approval/market access for Pediatric studies.
1. Provide clinical leadership and medical and scientific strategic input for pediatric clinical deliverables in the Pediatric TA. This includes ensuring alignment of GPP leading to PIP/PSP and protocols with the Clinical Development Plans (CDP), available disease and program level clinical standards, and the Target Product Profile (TPP).
2. Educate and advise in development of pediatric clinical sections of program level regulatory documents such as PIP, PSP, PPSR, Investigators Brochures, briefing books, safety updates, IND/NDA documents, and responses to Health Authorities. Responsible for high quality clinical/medical input into regulatory documents and registration dossiers for assigned section.
3. Support the pediatric program teams in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups, clinical trial networks), internal stakeholders (e.g., Clinical Trial Teams, Research, Exploratory Development, Marketing, HE&OR), and internal decision boards for assigned section.
4. For Pediatric TA, provide expert pediatric medical scientific input, as well as contributions to review of trial related documents (e.g., protocols, case report forms, data monitoring committees, data analysis plans, standards, resources, templates, publications), and presentation material for trial-related advisory boards, investigators meetings, and protocol training meetings.
5. Support clinical/scientific content of clinical communications, standards and documents related to Pediatric TA
6. Collaborate with operations to ensure optimal execution of pediatric Operational Plans including direct medical and operational support of trials as needed.
7. Offer pediatric expertise to the various Global Clinical Teams (GCTs).
8. Contributes to medical/scientific training of relevant Novartis stakeholders on pediatric disease area and
compound/molecule. May serve as speaker for Pediatric medical/scientific training.
9. Ensures career development of functional and direct reports and other clinical colleagues through active
participation in the performance management and talent planning processes. Provides on-boarding, training,
and mentoring support.
Key Performance Indicators:
Evidence of timely and quality clinical and medical strategic input e.g. metrices with reviews of protocols, pediatric investigation plans, DDPs, etc.
Timely delivery of high quality pediatric geared documents and protocols, etc., within the Clinical Development Plan with acceptance by key external and internal stakeholders, including relevant NIBR and CD&A associates
Strong evidence of support to NIBR/CD&A/TA driving high quality contributions to PIP/PSP, CDP and protocol reviews; development of pediatric disease/program clinical standards & guidances
High quality clinical/scientific content of clinical communications, advocacy and publications
Demonstrated ability to deputize for Sr.GPMD or GPMD , as well as other venues as needed
Evidence of independence in medical review of scientific and clinical data
The 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.
MD or equivalent medical degree required. Advanced clinical knowledge in Pediatrics required and subspecialties desired
Fluent oral and written English
>/=7years pediatric clinical trial experience with demonstrated ability to manage several trials in parallel with multidisciplinary trial teams
Demonstrated ability to establish strong scientific partnership with key investigators
Thorough knowledge of GCP, clinical trial design, statistics, and regulatory/clinical development process
Advanced knowledge of assigned pediatric therapy area is desired, with the capability to interpret, discuss and present trial or section level data
Strong interpersonal skills, influence without authority, organizational agility
Ability to work under pressure
Excellent negotiation and conflict resolution skills
Ability to resolve issues with minimal supervision and understand when to escalate
Excellent scientific writing skills
Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report results effectively
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