Novartis Farmacéutica
Head CD Pediatric CoE
Novartis Farmacéutica, East Hanover, New Jersey, us, 07936
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.About the Role
Major accountabilities: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) 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, representing 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 the 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 relevant Authorities.Accountable for oversight related to direct Pediatric Clinical Group support staff including performance management process, annual objectives, and performance appraisals for functional direct reports as required. Ensure efficient onboarding, 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 developing strong evidence and trust-based relationships 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 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?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.EEO Statement: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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.Accessibility & Reasonable AccommodationsThe 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 us.reasonableaccommodations@novartis.com 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.Division: DevelopmentBusiness Unit: Innovative MedicinesLocation: USASite: East HanoverCompany / Legal Entity: U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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Major accountabilities: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) 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, representing 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 the 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 relevant Authorities.Accountable for oversight related to direct Pediatric Clinical Group support staff including performance management process, annual objectives, and performance appraisals for functional direct reports as required. Ensure efficient onboarding, 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 developing strong evidence and trust-based relationships 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 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?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.EEO Statement: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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.Accessibility & Reasonable AccommodationsThe 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 us.reasonableaccommodations@novartis.com 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.Division: DevelopmentBusiness Unit: Innovative MedicinesLocation: USASite: East HanoverCompany / Legal Entity: U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
#J-18808-Ljbffr