Clinical Development Medical Director

Clinical Development Medical Director - Renal
Overview: 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 CDMD is the clinical leader of defined program-level activities (e.g., submission documents, briefing books, clinical study reports), and may lead a section of a clinical program under the leadership of the Global Program Clinical Head (GPCH).
Responsibilities
Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including protocol sections, data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities).
Drive execution of the program section 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 the Clinical Scientific Expert (CSE).
May be the Program Manager for other associates (e.g., CSE).
May function as study medical monitor.
Support GPCH in ensuring overall safety of the molecule.
May be a core member of the Safety Management Team, and support program safety reporting (e.g., PSURs, DSURs, and safety-related documents) in collaboration with Patient Safety.
Support the Clinical Development Head by providing medical input into the Clinical Development Plan (CDP) and clinical trial package reviews, and contribute to the development of disease clinical standards for disease areas.
Provide support to the GPCH/CDH in interactions with external partners (regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups) and internal partners (clinical trial team, Medical Affairs, Commercial, Health Economics & Outcomes Research), and decision boards.
Collaborate with Novartis Biomedical Research/Translational Medicine to drive transition of early development projects to Transition Decision Point and with Business Development, including target identification and due diligences.
Support career development of program teams through performance management and talent planning; provide onboarding, training, and mentoring support.
Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule; may serve as a speaker for Global Clinical team.
Minimum Requirements
MD (or equivalent medical degree) required.
Training in nephrology 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, preferably spanning clinical activities in phases I through IV.
3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (planning, executing, reporting, and publishing) in a global/matrixed environment.
Showcase advanced knowledge of the assigned therapeutic area and demonstrate ability to establish strong scientific partnerships.
Demonstrate thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes.
People management experience preferred, especially at the global level (this may include management in a matrixed environment).
Position Details
Seniority level: Director
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Pharmaceutical Manufacturing
Location: Dublin, County Dublin, Ireland
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
#J-18808-Ljbffr