Clinical Development Medical Director

Novartis • East Hanover, NJ

273d • $236,400 - $439,600

About The Position

As a Clinical Development Medical Director, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g., submission activities, briefing books, clinical study reports, etc.) and/or a large, complex trial, under the leadership of the Global Program Clinical Head (GPCH). May also lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).

Requirements

• MD (or equivalent medical degree) required.
• Training in cardiology preferred.
• Medical Board certification preferred.
• 4+ years Clinical practice experience (including residency) preferred.
• Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required.
• 5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry.
• 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials.
• Showcase advanced knowledge of assigned therapeutic area.
• Demonstrate ability to establish strong scientific partnership with key partners.
• Need thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes.

Nice To Haves

• People management experience preferred, especially at the global level.

Responsibilities

• Provide clinical leadership and medical strategic input for deliverables in the assigned project/program.
• Deliverables may include sections of individual protocols consistent with the clinical development plan (CDP), data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
• Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates.
• Oversee/conduct medical and scientific review of trial data with Clinical Scientific Expert (CSE).
• Support GPCH in ensuring overall safety of the molecule.
• Provide support to the GPCH or CDH in interactions with external partners and internal partners.
• Work with BR (Novartis Biomedical Research)/Translational Medicine to drive transition of early development projects.
• Ensure career development of Program Reports and clinical colleagues through active participation in performance management and talent planning processes.
• Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule.

Benefits

• Salary range: $236,400 to $439,600/year.
• Sign-on bonus, restricted stock units, and discretionary awards.
• Full range of medical, financial, and/or other benefits including 401(k) eligibility.
• Various paid time off benefits, such as vacation, sick time, and parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree