The Executive Director will lead cross functional groups in the developing and execution clinical studies and will play a key leadership role in clinical development programs for non-melanoma skin cancers including CSCC, BCC, MCC, and angiosarcoma, including being accountable for deliverables of the Replimune pipeline to the Executive Leadership Team. The Executive Director will often take the lead on regulatory interactions.

Reporting to the CMO/VP Clinical Development, the Executive Director will be responsible for designing studies within the Replimune pipeline in both early and late stage whilst overseeing other MD/PhD clinical team members (including clinical scientists). The Executive Director will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research. The Executive Director will also ensure and define strategy for external stakeholder partnership to build, establish and maintain Replimune as a key and competitive player.

• Lead and demonstrate ownership of the design and implementation of a clinical development program or programs for non-melanoma skin cancer in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues
• Leads the cross-functional study team on the following activities, including but not limited to:
  • Defines clinical strategy, leading clinical activities related to preparation/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 experts.
  • Organizes and conducts consultations with global opinion leaders.
  • Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments.
  • Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
• Responsible for oversight of medical monitoring activities in partnership with CRO, biostatics, clinical operations, and program leadership cross functional groups
• Ensures and defines Clinical Team compliance strategy with regulatory guidelines as well as applicable SOPs regarding clinical safety.
• Leads clinical groups in regulatory interactions.
• Presents study and pipeline conclusions to Management and determine how individual study results impact the overall compound and pipeline strategy.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Make final decisions regarding study conduct related to scientific integrity.

• D. degree.
• Board Certification/Eligibility in Dermatology or Oncology/Haematology or other closely relevant therapeutic area (MD/Ph.D. preferred)

Experience and skill requirement:

• 8+ years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials.
• Hands on patient care experience highly preferred
• Recognized expertise in clinical trials, advanced understanding of statistical principles, medical monitoring, and study analysis.
• Demonstrated ability to perform literature research, analyse and author clinical trial publications.
• Successful history preparing and filing INDs and NDAs/BLAs resulting in drug approvals both in the US and preferably ex-US is desirable.
• Previous oversight of Clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report)
• Excellent communications skills (verbal and written); capable of articulating the Company's clinical strategies and results to worldwide audiences.
• Ability and strong desire/drive to "make things happen." A results-oriented work ethic, a positive, can-do attitude, and a proven ability to build an effective organization by attracting and retaining high calibre personnel.
• Ability to manage clinical trial resources including budgets, human resource needs and prioritization changes/challenges.
• Effective leadership, people management, a team builder style and a global orientation are essential.
• Must have highest personal values and ethical standards.