Clinical Development Medical Director

Novartis Pharmaceuticals   •  

East Hanover, NJ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 55 days ago

Job Description

Clinical Development Medical Director


The Clinical Development Medical Director is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).


Your responsibilities include, but not limited to:


•Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.


•Leads development of 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).


•Drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates if applicable.

•May be the Program Manager of other associates (e.g.., CTH, CSE). 5) May act as study medical monitor.

•Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety.


•HE&OR), and internal decision boards 9) May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences


What you'll bring to the role:


•MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification


•5 years of involvement in clinical research or drug development in an academic or industry environment 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 in pharmaceutical industry

•Advanced knowledge of assigned therapeutic area required

•Demonstrated ability to establish strong scientific partnership with key stakeholders

•Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process


Desirable Requirements:


•People management experience preferred, this may include management in a matrix environment. Global people management experience preferred.


Why consider Novartis?



817 million. That's how many lives our products touched in 2018. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?


We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.


We are Novartis. Join us and help us reimagine medicine.


EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

•MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification


•5 years of involvement in clinical research or drug development in an academic or industry environment 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 in pharmaceutical industry

•Advanced knowledge of assigned therapeutic area required

•Demonstrated ability to establish strong scientific partnership with key stakeholders

•Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process