Clinical Development Medical Director, Neuroscience

Job Description Summary

Onsite
#LI-Onsite

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 Neuroimmunology 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 

This position will be located at the East Hanover site and will not have the ability to be located remotely. This position will require 5% travel as defined by the business (domestic and/ or international).  Please note that this role would not provide relocation, and only local candidates will be considered.
 

Role Requirements:
Essential Requirements:

• MD (or equivalent medical degree) required and advanced knowledge and clinical training in a medical/scientific area (preferably Neurology or background in CNS drug development)

• 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 myasthenia gravis preferred

• 4+ years Clinical practice experience (including residency) preferred

• Medical Board certification

• People management experience preferred, especially at the global level (this may include management in a matrix environment)
   

The pay range for this position at commencement of employment is expected to be between: $257,600 and $386,400/year; however, while salary ranges are effe