Director, Clinical Development

Overview

Reporting into the Chief Medical Officer (CMO) or VP Clinical Development (VPCD), the Senior Director, Clinical Development (SDCD) will be assisting in the implementation of the Replimune drug development strategy and will be taking a leadership and contributor role in enabling all aspects of individual drug programs. The SDCD will lead or support conduct of clinical studies and will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research. The SDCD will provide clinical input on clinical protocol development, regulatory interactions, patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, and presentation of data at national and international meetings. The SDCD will have both an inward and outward facing presence, including assisting the clinical operations team in the site evaluation and selection process for assigned clinical trials. This position may also work closely with preclinical functions and may be involved in interactions with strategic or collaboration partners.

Responsibilities

• Contributes to the overall clinical strategy for all or select RP programs from early development, through regulatory submissions and post-commercialization, with an emphasis from mid to late stages of
• Serve as Replimune’s clinical lead and point person on assigned programs and clinical trials from initiation to study discontinuation. Leads or facilitates cross-functional clinical development and/or study team(s) on the following activities, including but not limited to:
  • Designs studies as per clinical strategy, driving clinical activities related to preparation and approval of synopses, protocols and the conduct of clinical studies.
  • Responsible for the relevance and accuracy of medical science underpinning of clinical study based on thorough scientific review and consultation with internal and external
  • Organizes and conducts consultations with global opinion leaders and

contributing to or even leading Advisory Board meetings.

• Reviews and finalizes the medical and scientific portions of clinical study concepts and clinical study protocols and
• Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory
• Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study

• Responsible for medical monitoring activities in partnership with CRO, pharmacovigilance, biostatistics, clinical operations, and program leadership for, including but not limited to,
  • Assessing issues related to study conduct
  • Individual subject safety, in partnership with CRO responsible for trial
  • Program, trial or data risks, creating, and implementing mitigation strategies
  • Maintains and develops relationship with key study investigators
• Provide medical input and guidance to development and study/project teams and work collaboratively with cross-functional team members, such Data Management, Medical Directors and Clinical Scientists, Medical Safety and Pharmacovigilance and Medical Affairs to coordinate real time availability of clinical trial data, assuring data integrity, including safety, efficacy, pharmacokinetic, and correlative studies data to provide consolidated information for trial progress. Direct the interpretation of clinical and translational study data. Presents to internal governance committee or management and helps determine how individual study results impact the overall compound

 

• Authors/contributes to clinical sections of communications/documentation for regulatory agencies and is a key contributor in meetings with agencies. Supports generation and coordination of clinical documents and deliverables in support of regulatory filings, such as clinical study reports, DSURs, PSURs, regulatory submission sections, and investigator’s brochures, as well as provides input to regulatory
• Ensures that all the activities and clinical programs are in compliance with the GCP and regulatory requirements, as well as local and institutional
• Work with the Regulatory team and other cross functional representatives to ensure the timely preparation of high-quality documents to be submitted to the FDA and other health authorities for review, and represent Clinical at meetings with the FDA, EMEA and other regulatory

• Work with program management to assure deep integration of objectives, achievement of milestones according to the timelines, and optimal use of resources across
• Support the tactical development of clini