Job ID
REQ-10050085
Date: May 19, 2025
Location: Switzerland
Summary
The Clinical Development Medical Director (CDMD) serves as the global clinical leader overseeing defined and assigned program-level activities and deliverables, such as submissions and briefing books, or clinical trials, under the guidance of the GPCH or Sr CDMD.
About the Role
This hybrid role can be based in Basel, Dublin, London, or Barcelona.
Major Accountabilities:
- Provide clinical leadership, along with scientific and medical strategic input for all clinical deliverables related to assigned program activities. Clinical deliverables may include sections of individual protocols consistent with Integrated Development Plans (IDP) and Clinical Development Plans (CDP), clinical data reviews, program-specific standards, regulatory documents, registration dossiers, and publications.
- Lead the development of clinical sections of trial and program-level regulatory documents, such as Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities.
- Drive the execution of the clinical program section in collaboration with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates.
- Provide medical oversight and leadership of trials, potentially acting as medical monitor, while contributing to final analyses and interpretations, including the development of Clinical Study Reports (CSRs), publications, and presentations.
- Support the GPCH or Sr CDMD in ongoing benefit/risk assessments and safety monitoring of the molecule, and participate as a core member of the Safety Management Team (SMT). This includes collaboration on overall program safety reporting, such as Periodic Safety Update Reports (PSURs) and Drug Safety Update Reports (DSURs).
- May be assigned to provide medical input into IDP/CDP and Clinical Trial Protocol (CTP) reviews, contributing to the development of clinical standards for new disease areas.
- Act as a medical expert supporting the GPCH or CDH/TAH in engagement with external stakeholders (regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, and patient advocacy groups) as well as internal stakeholders.
- Collaborate with Biomedical Research/Translational Medical Sciences to facilitate the transition of pre-Proof of Concept (PoC) projects to Development Decision Point (DDP) and support BD&L efforts, including target identification and diligence.
Minimum Requirements:
- MD or an equivalent medical degree is required, with advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty), and Medical Board certification preferred.
- A minimum of 4 years of clinical practice experience (including residency) is preferred.
- 5 years of experience in clinical research or global drug development in an academic or industry setting covering activities in Phases I through IV. A minimum of 3 years should involve conducting clinical trials in a global/matrix environment within the pharmaceutical industry, with experience in late-phase clinical development preferred.
- Proven scientific acumen with the ability to analyze and interpret scientific literature and data effectively.
- Advanced knowledge of the assigned therapeutic area is essential.
- Demonstrated ability to establish strong scientific partnerships with key stakeholders.
Application Process
Apply online using the form below. Please note that only applications matching the job profile will be considered.
Why Novartis?
At Novartis, helping individuals with diseases and their families requires more than innovative science; it takes a community of dedicated and passionate professionals. Together, we collaborate, support, and inspire each other, combining our efforts to achieve breakthroughs that can transform patients' lives. Are you ready to help create a brighter future together?
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Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations for individuals with medical conditions or disabilities. If you require assistance during the recruitment process or additional information about the essential functions of the position, please reach out via email and include the job requisition number in your message.
Company Information
Division: Development
Business Unit: Universal Hierarchy Node
Company/Legal Entity: Novartis Pharma AG
Location: Basel (City), Switzerland
Alternative Locations: Barcelona, Spain; Dublin, Ireland; London, United Kingdom
Job Type: Full time
Employment Type: Regular
Shift Work: No
Novartis is dedicated to fostering an exceptional and inclusive work environment, aiming to create diverse teams that reflect the richness of the communities we serve.