Clinical Development Medical Director - Cardiology

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 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 and/or participate in early development transitions.

Location:

London UK, Barcelona Spain or Dublin, Ireland

• Provide clinical leadership and medical strategic input for deliverables in the assigned project/program. Deliverables may include sections of individual protocols, 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 Clinical Scientific Expert (CSE). May be the Program Manager of other associates and 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 or CDH in interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (e.g., clinical trial team, Medical Affairs, Commercial, Health Economics & Outcomes Research), and decision boards.
• Work 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.
• Ensure career development of program reports and clinical colleagues through participation in performance management and talent planning processes. Provide onboarding, training, and mentoring support.
• Contribute to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as a speaker for the Global Clinical team.

• 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 in the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV.
• 3+ years of experience in conducting clinical trials (planning, executing, reporting, and publishing) in a global/matrixed environment.
• Showcase advanced knowledge of the assigned therapeutic area and ability to establish strong scientific partnerships with key partners.
• 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 (in a matrixed 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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Novartis Life Handbook

Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If you need a reasonable accommodation for any part of the recruitment process, please email divers and include the job requisition number in your message.

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Ready to create a brighter future together?

Benefits and Rewards:
Learn about all the ways we’ll help you thrive personally and professionally.

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