Senior Clinical Development Medical Director – Renal
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • Ireland
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Job Level
Tech Stack
About the role
- Leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective.
- Oversight of the clinical development for the assigned programs and driving execution of the clinical development plan.
- Enabling an empowered organization that can navigate in a matrix environment and adjust quickly to business needs.
- Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
- Leading development of clinical sections of trial and program level regulatory documents.
- Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable.
- Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, acting as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues.
- Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP), and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas.
- As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
- May work with NIBR (Novartis Institute of Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligence together with other medical matters, as needed.
Requirements
- MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area;
- Clinical practice experience 4 years (including residency) and board certification or eligibility in disease area preferred
- Minimum of 7 years of experience in clinical research or drug development (Senior 10 + years plus)
- Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
- 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
- Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
- Demonstrated ability to establish effective scientific partnerships with key stakeholders
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Previous global people management experience is preferred, though this may include management in a matrix environment.
Benefits
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
- Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
- Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchdrug developmentclinical trial designGCPstatisticsclinical development processesmedical inputregulatory documentssafety reportingdisease clinical standards
Soft Skills
leadershipstrategic planningstakeholder engagementcommunicationcollaborationmatrix managementadaptabilitypartnership buildingproblem-solvingdecision-making
Certifications
MDboard certification