Associate Clinical Development Medical Director (Inmarket Brands)

Healthcare Businesswomen’s Association; London; Hybrid; GBP 100,000 - 130,000; Full time

Job summary

A leading company seeks an Associate Clinical Development Medical Director to oversee clinical trials, ensuring scientific and medical integrity. The role involves developing strategies, managing safety, and contributing to regulatory documents. Ideal candidates will have a strong clinical background and experience in drug development.

Qualifications

• At least 4 years of clinical practice experience, including residency, preferred.
• Minimum of 3 years involved in clinical research or drug development.

Responsibilities

• Provide clinical oversight and contribute to trial-related documents.
• Collaborate with Clinical Trial Team members for medical oversight.
• Manage patient safety and report trial data to safety boards.

Skills

Budget Management

Clinical Research

Protocol Development

Clinical Trials

Coaching

Cross-Functional Teams

Data Analysis

Learning Design

Lifesciences

Risk Management

Risk Monitoring

Education

MD or equivalent medical degree

Job description

Job Description Summary

The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical oversight of assigned clinical trial(s), including medical, safety, and data monitoring, as well as reporting quality data. Depending on the size and complexity, they may also be responsible for the scientific and medical strategy of specific sections of a clinical development program.

Job Responsibilities

• Provide clinical oversight, medical and scientific input, and contribute to the development of trial-related documents (e.g., CTPs, informed consent forms, case report forms, data monitoring committee charters, data analysis plans, reports, publications) for assigned trials in accordance with the Integrated Development Plan (IDP) and Clinical Development Plan (CDP).
• Develop materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training sessions for local medical organizations.
• Contribute to clinical sections of regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers).
• Collaborate with Clinical Trial Team members to ensure medical oversight and support of trials, including acting as the medical monitor and reviewing trial data and documents.
• Conduct ongoing medical and scientific review of trial data, supported by Clinical Scientific Experts and CDDs.
• Manage patient safety reporting to safety and clinical boards, under leadership of the Sr CDMD or GPCH.
• Assist in the final analysis and interpretation of data, including development of Clinical Study Reports, publications, and presentations.
• Support benefit/risk assessments and safety monitoring of the molecule, contributing to overall program safety reporting in collaboration with Patient Safety.
• Contribute to talent development through onboarding, coaching, mentoring, and fostering a positive CD culture.
• Participate in medical/scientific training for stakeholders and serve as a speaker when appropriate.

Minimum Requirements

• MD or equivalent medical degree.
• Advanced knowledge and clinical training in a relevant medical/scientific area, with Medical Board certification preferred.
• At least 4 years of clinical practice experience, including residency.

Work Experience

• Minimum of 3 years involved in clinical research or drug development across clinical phases I-IV.
• At least 2 years of comprehensive experience in conducting clinical trials in a global/matrix environment within the pharmaceutical industry.
• Knowledge of the disease area, with ability to interpret efficacy and safety data.
• Proven ability to collaborate effectively with stakeholders.
• Understanding of GCP, trial design, statistics, and regulatory processes.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives. We strive to be the most valued and trusted medicines company, driven by our people. Join us to be part of this mission! More info: https://www.novartis.com/about/strategy/people-and-culture

Benefits

Details about benefits and rewards are available in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards. We are committed to diversity and inclusion, building an inclusive environment and diverse teams that reflect the communities we serve.

Stay Connected

If this role isn't suitable but you'd like to stay informed about Novartis opportunities, join our network: https://talentnetwork.novartis.com/network

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Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring