Novartis Farmacéutica
Global Program Clinical Head Neuroscience (MD, PHD)
Novartis Farmacéutica, Hanover, Massachusetts, us, 02340
Global Program Clinical Head Neuroscience (MD, PHD)
Job ID REQ-10032148 Jan 02, 2025 USA Summary
With a 30-year history from the approval of the first targeted therapy, Novartis is pushing the boundaries of breakthrough science and innovation with bold science that seeks to transform lives as we strive in pursuit of cures for cancer. As Global Program Clinical Head (GPCH), you are the clinical lead of Neuroscience, full development product. You will develop and ensure the implementation of the Clinical Development plan and lead a cross-functional team of specialists such as Medical Directors, Trial Directors, Safety Leaders, Biostatisticians, and Regulatory Directors. About the Role
What you’ll be doing:
Responsible for clinical input to support Business Development & Licensing (BD&L) activities Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) Contribute to Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) for successful global regulatory approval/market access for one or more treatment indications. Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s). Lead a cross-functional team through the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents) with high quality and consistency. As the medical expert, lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders) and internal stakeholders (e.g., Research, Global Medical Affairs, Marketing). Ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies. Support registration, market access, and maintenance of product licenses for the compound(s). Plan and implement publication and clinical communication strategy in coordination with Global Medical Affairs. What you’ll bring to the role:
MD or Ph.D. degree with 6+ years’ experience in clinical research or drug development. A passion for Neuroscience. Advanced expertise in Neuroscience with ability to innovate in clinical development study designs. Knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process. Demonstrated ability to establish strong scientific partnership with key stakeholders. Demonstrated leadership and management skills with a track record of delivering high-quality projects in a global/matrix environment. You’ll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, and learning and development opportunities. Why Novartis?
769 million lives were touched by Novartis medicines in 2020. We believe new insights and solutions can be found at the intersection of medical science and digital innovation, and that a diverse, equitable, and inclusive environment inspires new ways of working. Join our Novartis Network:
Sign up to our talent community to stay connected and learn about suitable career opportunities. The Novartis Group of Companies are Equal Opportunity Employers committed to fostering a diverse and inclusive workplace. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities. Division Development Business Unit Innovative Medicines Location USA State New Jersey Site East Hanover Company / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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Job ID REQ-10032148 Jan 02, 2025 USA Summary
With a 30-year history from the approval of the first targeted therapy, Novartis is pushing the boundaries of breakthrough science and innovation with bold science that seeks to transform lives as we strive in pursuit of cures for cancer. As Global Program Clinical Head (GPCH), you are the clinical lead of Neuroscience, full development product. You will develop and ensure the implementation of the Clinical Development plan and lead a cross-functional team of specialists such as Medical Directors, Trial Directors, Safety Leaders, Biostatisticians, and Regulatory Directors. About the Role
What you’ll be doing:
Responsible for clinical input to support Business Development & Licensing (BD&L) activities Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) Contribute to Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) for successful global regulatory approval/market access for one or more treatment indications. Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s). Lead a cross-functional team through the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents) with high quality and consistency. As the medical expert, lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders) and internal stakeholders (e.g., Research, Global Medical Affairs, Marketing). Ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies. Support registration, market access, and maintenance of product licenses for the compound(s). Plan and implement publication and clinical communication strategy in coordination with Global Medical Affairs. What you’ll bring to the role:
MD or Ph.D. degree with 6+ years’ experience in clinical research or drug development. A passion for Neuroscience. Advanced expertise in Neuroscience with ability to innovate in clinical development study designs. Knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process. Demonstrated ability to establish strong scientific partnership with key stakeholders. Demonstrated leadership and management skills with a track record of delivering high-quality projects in a global/matrix environment. You’ll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, and learning and development opportunities. Why Novartis?
769 million lives were touched by Novartis medicines in 2020. We believe new insights and solutions can be found at the intersection of medical science and digital innovation, and that a diverse, equitable, and inclusive environment inspires new ways of working. Join our Novartis Network:
Sign up to our talent community to stay connected and learn about suitable career opportunities. The Novartis Group of Companies are Equal Opportunity Employers committed to fostering a diverse and inclusive workplace. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities. Division Development Business Unit Innovative Medicines Location USA State New Jersey Site East Hanover Company / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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