Clinical Development Medical Senior Director

The Clinical Development Medical Senior Director leads innovative approaches to clinical development, develops and oversees implementation of solutions for complex problems with sustained and significant impact, and acts as subject matter expert for clinical development, influencing the decisions of senior leaders. They may lead or chair cross functional teams at the category or portfolio level including governance or advisory committees. They ensure medical & scientific integrity and the wellbeing of participants enrolled in clinical trials, design and execute high-quality studies, maintain compliance, manage risks and emerging clinical and medical issues, and support interpretation and communication of clinical data.

This role is the primary contact for internal and external stakeholders for clinical and medical aspects of the protocol, supports strategic development, and provides matrix management.

• Leadership
  • Autonomously and independently leads clinical execution of one or more studies of high complexity and significant business impact. May be accountable for program level clinical deliverables.
  • Leads innovative approaches to clinical development, develops options and oversees implementation of solutions for complex problems.
  • May lead or chair cross functional teams at the category or portfolio level including governance or advisory committees.
  • Provides matrix management to clinical colleagues or a cross‑functional team in clinical development.
• Content Creation
  • 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.
  • Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Clinical & Safety Oversight
  • 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.
  • Provides clinical/medical input to the development of data collection tools.
  • Responsible for providing clinical/medical input to SAP, TLFs and BDR.
  • Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
  • Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Reviews and approves final document.
  • 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.
  • 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 ICD.
  • 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…