Clinical Development Medical Director - CRMSummary: Are you passionate about shaping the future of clinical development and making a meaningful impact to patients?

About The RoleWe are looking for an experienced and visionary

Clinical Development Medical Director

(CDMD) to take the lead in driving the strategic planning and execution of our cutting-edge clinical programs. In this pivotal role, you will oversee the end-to-end clinical development process for assigned programs. Your expertise and leadership will ensure the seamless execution of clinical development plans while fostering a culture of empowerment, agility, and collaboration within a dynamic matrixed environment. If you thrive in a fast-paced, purpose-driven organization and have the skills to adapt swiftly to evolving business needs, we would love to have you on board!

Major Accountabilities

Providing or supporting 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, and may act 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 Biomedical Research/ Translational Medical Sciences to drive transition of pre-PoC projects to Development Decision Point (DDP) and with BDandL including target identification and due diligences together with other medical matters, as needed

Essential Requirements

MD or equivalent medical degree is required in addition to advanced knowledge and clinical training

Clinical practice experience (including residency/fellowship) and board certification or eligibility in Nephrology

Experience in clinical research or drug development preferred

Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required

Experience in contributing to and accomplishing in all aspects of conducting clinical trials (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

Commitment To Diversity and InclusionWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why NovartisHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Benefits and RewardsRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: see Novartis careers resources.

Job Details

Seniority level: Director

Employment type: Full-time

Job function: Research, Analyst, and Information Technology

Industries: Pharmaceutical Manufacturing

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