Associate Clinical Development Director (VHB)
Job ID REQ-10057574
Jul 10, 2025
United Kingdom
Summary
Location: London, United Kingdom or Dublin, Ireland
Role Purpose: The Associate Clinical Development Director (Assoc. CDD) in Neurosciences provides input to the development of protocols for assigned global clinical trials, scientific monitoring, and reporting of quality data. May support the development of the clinical and scientific strategy of assigned sections of a clinical development program, depending on size and complexity.
About the Role
Major accountabilities:
- Provides input to the development of clinical development strategy and contributes to trial-related documents (e.g., CTPs, informed consent forms, case report forms, data monitoring committee charters, data analysis plans, reports, publications) for assigned clinical trials, aligned with the Clinical Development Plan (CDP).
- Develops materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for Novartis local clinical development teams.
- Provides clinical and scientific input into clinical sections of regulatory documents (e.g., Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, responses to Health Authorities).
- In collaboration with Clinical Trial Team members:
a) Ensures clinical development oversight and support of trials.
b) Conducts ongoing scientific review of clinical trial data with Clinical Scientific Experts under oversight.
c) Manages patient safety reports with safety and clinical boards, collaborating with patient safety teams.
d) Provides input into final analyses, interpretation, and development of Clinical Study Reports, publications, and presentations. - Contributes to global initiatives such as process improvement, training, SOP development, and other Clinical Development functions.
- May lead clinical trials as Clinical Scientific Lead, providing leadership and guidance for all clinical aspects in collaboration with medical monitors and/or CDMD.
- Ensures quality clinical and scientific strategic input, timely delivery of high-quality clinical trial protocols and deliverables.
- Applies effective research methodologies, including trial design, efficacy endpoints, safety assessments, and risk management across disease areas and phases.
- Supports Therapeutic Area (TA) through contributions to Clinical Development Plans and protocol reviews.
- Supports the development of clinical standards, publications, and presentations.
- Contributes to regulatory documents, including Investigator’s Brochures, briefing books, safety updates, and submission dossiers.
- Demonstrates Novartis Values and Behaviors effectively.
Qualifications: Advanced degree in life sciences/healthcare (or clinically relevant degree) required; PharmD or PhD strongly preferred.
Experience: ≥3 years in clinical research or drug development; ≥2 years in global/matrix clinical trial execution; knowledge in neurology, cell & gene therapy, rare or neuromuscular diseases, neuroinflammation, neurodegeneration, MS or related fields preferred.
Languages: Fluent in English, oral and written.
Professional Requirements:
- Proven experience in clinical trial planning, execution, reporting, and publishing.
- Knowledge of disease areas, trial design, statistics, regulatory processes.
- Strong communication, interpersonal, negotiation, and conflict resolution skills.
Commitment to Diversity & Inclusion: We aim to build an inclusive, diverse work environment reflecting the patients and communities we serve.
Benefits and Rewards: Learn more in our handbook. Join Novartis to help improve lives through innovative science and collaborative efforts. More info: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Sign up to stay connected and learn about opportunities: https://talentnetwork.novartis.com/network
Location: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. or Dublin (Country President Office, CPO), Ireland
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No