Job Title and Level
Clinical Development Director, Level 6
Location
Office Location: London UK or Dublin Ireland
Hybrid work: 12 days on-site per month
Job Description Summary
The Clinical Development Director (CDD) is the clinical/scientific expert and, if assigned, leads clinical development for a section of a global clinical program and/or trial (e.g., an indication, a new formulation, a specific development phase) or a large, complex trial, under the leadership of the GPCH. The CDD may have a team leadership role for sections of clinical programs and/or global clinical trials, depending on size, nature and complexity.
Major Accountabilities
- Supports and, if assigned, leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Deliverables may include the clinical development strategy for the section(s), clinical sections of protocols aligned with Integrated Development Plans (IDP), clinical data review standards, clinical components of regulatory documents/registration dossiers, and publications.
- Contributes and, if assigned, leads development and delivery of clinical sections of trial- and program-level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to health authorities).
- Drives execution of the section of the clinical program in partnership with global line functions (clinical operations, trial leaders, data management/analysis, and regional/country clinical development associates).
- Ensures ongoing clinical and scientific review of clinical trial data.
- Works with data management and statistics teams to ensure data quality and appropriate analysis of clinical trial results.
- May be the Program or Function Manager of associates (e.g., CDD or associate CDD).
- Supports GPCH in assessing the overall risk-benefit of the molecule for the assigned section; may be a core member of the Safety Management Team (SMT) and supports overall program safety reporting (e.g., PSURs, DSURs, and other safety-related documents) in collaboration with the medical monitor, CDMD and Patient Safety.
- If assigned, may co-lead the Global Clinical Team (GCT). Represents the section in Global Program Team (GPT) meetings and serves as the section spokesperson in internal and external meetings/boards, as assigned.
- Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews and contributing to the development of disease clinical standards for new disease areas. May take on additional therapeutic area responsibilities as directed by the CDH.
Minimum Requirements
Work Experience:
- Advanced degree in life sciences/healthcare (or clinically relevant degree). PharmD or PhD strongly preferred.
- 7+ years of involvement in clinical research and global drug development in academic or industry settings, spanning Phases I–IV. At least 5 years of experience in planning, executing, reporting and publishing clinical trials in a global/matrix pharmaceutical environment. Late-phase clinical development experience strongly preferred.
- Solid scientific writing skills.
- Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA) preferred.
- Strong ability to analyze and interpret scientific literature and data; high data quality and analytical acumen.
- Preferred knowledge/experience in the assigned therapeutic area.
- Demonstrated ability to establish strong scientific partnerships with internal and external stakeholders.
- 3+ years of people management experience (may include matrix environments).
Note: Final job title and responsibilities may be commensurate with the successful candidate’s level of expertise.
Company Commitment and Network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If this role is not suitable to your experience or career goals but you wish to stay connected for future opportunities, join the Novartis Network: https://talentnetwork.novartis.com/network
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