Clinical Development Medical Director - CRM

Job Description Summary

Are you passionate about shaping the future of clinical development and making a meaningful impact to patients?Job Description

We 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 programLeading development of clinical sections of trial and program level regulatory documentsDriving execution, 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 BDandL (Business Development and Licensing) 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 NephrologyExperience in clinical research or drug development preferredExperience 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 (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 reportsDemonstrated ability to establish effective scientific partnerships with key stakeholdersWorking knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processesRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life HandbookCommitment to Diversity and Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.Skills Desired

Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk ..... full job details .....