Clinical Development Medical Director - CRM
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 program
- Leading development of clinical sections of trial and program level regulatory documents
- Driving 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 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 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.
- 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 (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
Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring
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