16 ago
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Novartis
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Cataluña
Salary Range:85,100.00 - 158,100.00Job Description SummaryThe Senior* Clinical Development Medical Director (Sr* CDMD) will lead the end-to-end strategy and execution of assigned renal clinical development program(s) across the full Research, Development and Commercial (RDC) continuum; from early development through pivotal/registrational phases. This is a key leadership role requiring hands-on experience in both early and late phase renal drug development. With the ability to translate emerging data into a clear clinical and regulatory path, drive delivery in a integral matrix, and ensure rigorous benefit-risk decision making throughout the program lifecycle.Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical programLeading development of clinical sections of trial and program level regulatory documentsDriving 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 applicableSupporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleaguesSupporting 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 areasAs a medical expert, supporting the (Sr.)
GPCH or CDH in interactions with external and internal stakeholders and decision boardsMay work with BR (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 diligences together with other medical matters, as needed.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 preferredMinimum of 10 years of experience in clinical research or drug developmentExperience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV is required.
Working knowledge of renal 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 reportsDemonstrated ability to establish effective scientific partnerships with key stakeholdersWorking knowledge of GCP, clinical trial design, statistics,
and regulatory and clinical development processesPrevious global people management experience is preferred, though this may include management in a matrix environment.Final job title (Clinical Development Medical Director, Level 6/ Senior Clinical Development Medical Director, Level 6) and associated responsibilities will be commensurate with the successful candidates’ level of expertiseBenefits & RewardsAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines.
Read our brochure to learn more about our global total rewards offering: Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.
Novartis Life
HandbookSkills DesiredClinical Trials, Cross-Functional Teamwork, Data Analysis, Data Monitoring, Drug Development, Drug Discovery Process, Medical Research, Medical Strategy (Inactive), People ManagementSummaryLocation: Full time
📌 Senior Clinical Development Medical Director (Cataluña)
🏢 Novartis
📍 Cataluña