Director, Clinical Development Medical Director (MD Required)

Job Summary

The Director, Clinical Development Medical Director (MD Required):

• Is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high-quality clinical trials, employing quantitative design principles, and clinical best practices to deliver both clinical and operational excellence.
• Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Clinical Development Medical Director is accountable for timely delivery of a quality protocol, clinical execution of one or more large and / or complex clinical trials and supports appropriate interpretation and communication of clinical trial data.
• Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review. Performs medical monitoring of one of more clinical trials.
• Will be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
• May also provide matrix management support of one or more R&D Internal Medicine clinicians on one or more clinical studies or across a clinical program.

Job Responsibilities

• Performs medical monitoring on one or more clinical trials:

• Provides study-related medical information and assistance, e.g., on:
  • medical questions from investigators, site personnel and non-study health care providers
  • safety findings, medical issues, and complex serious adverse events
  • audits or inspection medical responses

• Contributes to final significant quality event medical assessments.
• Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
• Reviews required safety text and endorses significant medical changes in the Informed Consent Document.

• Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. May be accountable for program level clinical deliverables.
• Provides clinical/medical input to support development of the protocol design document (PDD).
• Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/ supports the Global Development Lead in governance review and approval process.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical/medical input to the development of data collection tools. Responsible for providing clinical/medical input to SAP, TLFs and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Inputs to, reviews, and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations.
• Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
• Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol
• Reviews, reports and manages protocol deviations.
• Reviews patient level and cumulative data per the data review plan across one or more studies.
• Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (eg ICD) are updated as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
• Acts as the medical monitor on one or more clinical trials.
• Ensures TMF compliance for clinical documents
• Inputs and reviews the Clinical Study Report