(Senior) Clinical Development Director - CV in City of Westminster

Senior Clinical Development Director (CDD) – Cardio Renal & Metabolic (CRM) Development Unit

Senior Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective.

About the Role

As a Senior CDD in the Cardiovascular/Metabolic therapeutic area, you will have oversight of the clinical development for the assigned programs and drive the execution of the clinical development plan. You will enable an empowered organization that can navigate a matrix environment and adjust quickly to business needs.

Responsibilities

• Providing clinical leadership and strategic input for all clinical deliverables within the assigned project or section of a clinical program (e.g., training protocols, sub-studies, Integrated Development Plans (IDP), data review, program-specific standards, regulatory documents, and publications).
• Leading development of clinical sections of trial and program-level regulatory documents.
• Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable.
• Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from the Medical Lead.
• Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety.
• As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
• Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may act as Program Manager of other associates.

Qualifications

• Advanced degree in life sciences/healthcare (or clinically relevant degree) – PharmD or PhD strongly preferred.
• Fluent oral and written English.
• Minimum 5 years (for CDD) and 7 years experience (for Senior CDD) in clinical research or drug development.
• Working knowledge of the assigned disease area (Cardiovascular) with proven ability to interpret, discuss, and present efficacy and safety data related to clinical trial(s) or program level.
• Demonstrated ability to establish effective working relationships with key investigators.
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
• Strong communication skills with the ability to work in a cross-functional and global organization.

Title Variations

\”Final job title (Associate Clinical Development Director, Level 5 / Clinical Development Director, Level 6 / Senior Clinical Development Director, Level 6) and associated responsibilities will be commensurate with the successful candidate\’s level of expertise.\”

Why Novartis

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Learn more about our purpose, vision, and culture: https://www.novartis.com/about/strategy/people-and-culture. Detailed benefits and rewards are available in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards. Connect through Novartis Network: https://talentnetwork.novartis.com/network.

Division

Development Business Unit – Development