Sr Clinical Development Medical Director

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 3 months ago

60! With a 60-year history in neuroscience, Novartis has brought innovative therapies to patients with e.g. Multiple Sclerosis, Alzheimer's disease, Parkinson's Disease, Epilepsy, Depression and Migraine. We have a world-class pipeline in neurodegeneration, neuro-inflammation, neuromuscular and psychiatric diseases. Our holistic R&D approach includes cutting edge molecules, innovative approaches to technology, biomarker and digital therapeutics to seek better solutions for patients.

As a Senior Clinical Development Medical Director, Neurology, you will join a dynamic team who are dedicated to developing treatments to slow the progression of degenerative orphan diseases including Huntington's disease and Spinal Muscular Atrophy.

Your role will be to lead and provide medical strategic input for clinical deliverables or clinical sections of such deliverables (e.g. study protocols, pediatric plan, clinical data review, safety updates, health authority responses, investigator brochures, submission dossiers, briefing books, etc.) for a program in early stage clinical development in Huntington's disease and a more advanced program in spinal muscular atrophy.

Your responsibilities will include:

  • Providing clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications

  • Leading development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)

  • Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates if applicable

  • Supporting (Sr.) Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, acting as a core member of the Safety Management Team, and supporting overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports, and other safety related documents), in collaboration with Patient Safety

  • Supporting the Therapeutic Area Head (TAH) by providing medical input into Integrated Development Plans and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other responsibilities as directed by the TAH

  • As a medical expert, supporting the (Sr.) Global Program Clinical Head or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Clinical Trial Team, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards

  • MD or equivalent medical degree required. Advanced knowledge and clinical training in neurology required, with Medical Board certification

  • Experience >7 years in late or early drug development for psychiatry and/or neurology, orphan indication or neurodegenerative disease experience preferred

  • Demonstrated ability to establish strong scientific partnership with key stakeholders

  • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process

  • Demonstrated experience in data presentation and strong negotiation and diplomatic skills, experience with health authorities required

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Sr Clinical Development Medical Director

Novartis Pharmaceuticals