Novartis UK
Clinical Development Director - Renal
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Clinical Development Director (CDD)
Summary
The Clinical Development Director (CDD) serves as the clinical/scientific expert and may lead the clinical development for a section of a global clinical program and/or trial. This could involve areas such as a specific indication, a new formulation, or a development phase, or managing large, complex trials under the leadership of the Global Program Clinical Head (GPCH). The role also involves potential team leadership for sections of clinical programs and/or trials based on the size, nature, and complexity.
About the Role
Title: Clinical Development Director
Office Location: London, UK or Dublin, Ireland
Working Arrangement: Hybrid (12 days per month on-site)
Major Accountabilities
The CDD will be responsible for the following:
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Supports and, if assigned, leads the delivery of all clinical deliverables for the assigned section of a clinical program, which may include:
- Clinical development strategies for assigned program section(s)
- Clinical sections of individual protocols aligned with Integrated Development Plans (IDP)
- Clinical data review program adherence to program standards
- Clinical components of regulatory documents/registration dossiers
- Publications and knowledge dissemination
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Contributes and, if assigned, leads the development and delivery of clinical sections of trial and program-level regulatory documents, such as:
- Investigator’s Brochures
- Briefing books
- Safety updates
- Submission dossiers
- Health Authority responses
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Drives execution of assigned clinical program sections in collaboration with global functions, including:
- Clinical operations
- Trial leaders
- Data management/analysis teams
- Regional/country clinical development associates
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Ensures continual clinical and scientific review of clinical trial data.
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Works closely with data management and statistics teams to ensure data quality and accurate analysis of trial results.
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May assume the role of Program or Function Manager for associates (e.g., CDD, Associate CDD).
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Supports the GPCH in assessing the overall risk-benefit of the molecule for the assigned program section.
- May act as a core member of the Safety Management Team (SMT).
- Supports safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and related safety documents) in collaboration with Medical Monitors, Clinical Data Management Directors (CDMDs), and Patient Safety teams.
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May serve on and if assigned (co-)lead the Global Clinical Team (GCT) for assigned program sections.
- Acts as a spokesperson for the section in Global Program Team (GPT) meetings.
- Represents the assigned section in internal and external meetings/boards, as needed.
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Supports the Clinical Development Head (CDH) by:
- Providing clinical/scientific input into IDP/CDP and CTP reviews.
- Contributing to/leading disease clinical standard development for new therapeutic areas.
- Undertaking any additional therapeutic area (TA) responsibilities as directed by the CDH.
Minimum Requirements
Work Experience
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Education:
- Advanced degree in life sciences/healthcare or a clinically relevant degree.
- PharmD, or PhD strongly preferred.
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Experience:
- Proven experience working in clinical research/global drug development, spanning academic or industry environments covering all aspects of conductingclinical trials (Phase I through Phase IV).
- Minimum of 5 years of substantial contributions and achievements in clinical activities:
- Trial planning
- Trial execution
- Reporting
- Publishing
- Experience required in global/matrix pharmaceutical industry environments, with a preference for late-phase clinical development.
- Strong scientific writing skills.
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Regulatory Expertise:
- Experience with regulatory submissions preferred (e.g., IND, NDA/BLA, CTA, MAA).
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Scientific Acumen & Data Skills:
- High levels of analytical and interpretive skills to assess scientific literature and data.
- Strong affinity with data, data quality, and rigorous analysis.
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Specialized Knowledge/Experience:
- Preferred knowledge/experience in the assigned therapeutic area.
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Stakeholder Management:
- Demonstrated ability to establish strong partnerships with both internal and external stakeholders.
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Title & Responsibilities:
- Job title and responsibilities (e.g., Clinical Development Director, Level 6 / Senior Clinical Development Director, Level 6) will depend on the candidate’s expertise level.
Why Novartis
Novartis is dedicated to redefining medicine to improve and extend people’s lives, aiming to become the most valued and trusted pharmaceutical company in the world. Discover more about our mission and core values here.
Rewarding Benefits and Growth Opportunities: Navigate our site to explore the extensive range of benefits and perks offered by Novartis via our Novartis Life Handbook: Novartis Benefits & Rewards Portal.
Commitment to Diversity & Inclusion
Novartis is committed to fostering an inclusive and outstanding work environment, ensuring our teams reflect the diversity of patients and communities we serve.
Stay Connected: Sign up to the Novartis Talent Network to stay informed about career opportunities beyond this role: Join Novartis Network.
To be part of making a brighter future for patients is to align with Novartis' purpose. Collaborate, inspire, and innovate with purpose-driven individuals like you. Curious about how we can help revolutionize healthcare, together? Learn more: Visit Our Strategy & Culture Page.
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