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.
About the Role 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 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)
Novartis Compensation and Benefit Summary : The salary for this position is expected to range between $257,600 and $386,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here .
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Accessibility and Reasonable Accommodations: The 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
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EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The 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 [email protected] 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.
Job Tags
Remote job, Relocation, Home office,