Clinical Development Medical Director - Neurosciences

Job Description Summary

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. Primary focus of this role is Neuroimmunology disease area.

Job Description

Your responsibilities include, but are not limited to:

1. 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).
2. Develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings.
3. 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).
4. Oversee/conduct medical and scientific review of clinical trial data with Clinical Scientific Expert(s).
5. Provide input into final analyses and interpretation including the development of clinical study report, publications and internal/external presentations.
6. 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.
7. 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.
8. May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities, as needed.
9. Contribute to talent and career development of Clinical Development (CD) associates through on-boarding, coaching, and/or mentoring support; develop and foster CD culture.
10. 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.
11. Contribute to global initiatives (e.g., process improvement, training, SOP development, other CD line function initiatives).

What you'll bring to the role:

1. A passion for Neuroscience!
2. MD (or equivalent medical degree) required, with training in Neurology preferred.
3. 4+ years Clinical practice experience (including residency) preferred; Medical Board certification preferred.
4. Advanced knowledge and clinical training in a medical/scientific area (preferably Neurology or background in CNS drug development) required, with expertise in myasthenia gravis preferred.
5. 5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in Phases I through IV.
6. 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.
7. Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level.
8. Demonstrate ability to establish strong scientific partnership with key partners.
9. Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development processes.
10. People management experience preferred, especially at the global level (this may include management in a matrix environment).

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring