Clinical Development Medical Director - Cardiology

Novartis; London; On-site; GBP 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Clinical Development Medical Director specializing in cardiology. This pivotal role involves leading the scientific and clinical strategy for clinical trials, ensuring the execution of project deliverables, and collaborating with global teams. You will oversee trial data review, support safety management, and contribute to regulatory submissions. If you have a passion for advancing medical science and a strong background in clinical research, this opportunity offers a chance to make a significant impact in patient care and innovative therapies.

Qualifications

• 5+ years experience in clinical research or drug development.
• Advanced knowledge of clinical trial design and regulatory processes.

Responsibilities

• Provide clinical leadership and medical strategic input for deliverables.
• Oversee medical and scientific review of trial data.

Skills

Clinical Research

Cardiology

Good Clinical Practice

Statistical Analysis

People Management

Education

MD or equivalent medical degree

Medical Board certification

Job description

Clinical Development Medical Director - Cardiology

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Clinical Development Medical Director - Cardiology

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Summary

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.

Summary

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).

About The Role

Major accountabilities:

• 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 (e.g., investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities)
• 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). May be the Program Manager of 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 supports 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 CDP and clinical trial package reviews and contributing/driving 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 BR (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 active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring support
• Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for Global Clinical team
  
  

Minimum 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, preferably 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/matrixed environment
• 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
• People management experience preferred, especially at the global level (this may include management in a matrixed environment)
  
  

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Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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