Clinical Development Medical Director, Neuroscience

Band

Level 6

 

Job Description Summary

Onsite
#LI-Onsite
East Hanover, New Jersey

About the role:
As a Clinical Development Medical Director in our Neuroscience development unit, you will be responsible for the planning, medical and clinical oversight, and reporting of quality data of assigned clinical trials. In addition, you may be responsible for certain clinical and scientific aspects of a clinical development program, depending on the size and complexity. The primary focus of this role is neurodegenerative or movement disorder therapeutic area.

 

Job Description

Your Key Responsibilities:

• Provide clinical leadership, medical and scientific strategic input, and contribute to development of trial related documents (e.g., study protocols, informed consent forms, case report forms, committee charters, data analysis plans, reports, publications) for assigned clinical trial(s) consistent with the clinical development plan (CDP)
• Develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings
• Provide clinical and scientific input and contribute to 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)
• Oversee/conduct medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
• Provide input into final analyses and interpretation including the development of clinical study report, publications and internal/external presentations
• Support the Global Program Clinical Head in ensuring overall safety of the molecule, and may act as a core member of the Safety Management Team, supporting program safety reporting in collaboration with Patient Safety colleagues
• Support the Clinical Development Head with contributing to peer-review of clinical development plans, clinical trial protocols, and other clinical documents across various indications and programs, and support development of therapeutic area strategies, as needed
• May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities, as needed
• Contribute to talent and career development of clinical development (CD) associates through on-boarding, coaching, and/or mentoring support; develop and foster CD culture.
• Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule; may serve as speaker for franchise medical/scientific training
• Contribute to global initiatives (e.g., process improvement, training, SOP development, other CD line function initiatives)
   

Video Link  https://www.youtube.com/watch?v=ggbnzRY9z8w 
 

The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
 

Role Requirements:
Essential Requirements:

• MD (or equivalent medical degree) required and advanced knowledge and clinical training in a medical/scientific area (preferably Neurology)
• 5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in Phases I through IV
• 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environment
• Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• Demonstrate ability to establish strong scientific partnership with key partners
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development processes

Desired Requirements:

• Training in Neurology preferred; expertise in neurodegenerative or movement disorder (Huntington’s disease, Parkinsons, Alzheimer’s, etc.,) strongly preferred
• 4+ years clinical practice experience (including residency)
• Medical Board certification
• People management experience, especially at the global level (this may include management in a matrix environment)
   

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