• The Director of R&D Quality-Pharmacovigilance & Medical Affair is responsible for contributing to the development, implementation and maintenance of Quality Assurance systems and activities for Replimune’s clinical patient safety, commercial PV activities, and medical affairs enterprise (including but not limited to observational studies, medical information, and ISTs). This role will ensure that all relevant quality and regulatory requirements are met for good clinical practices (GCP) and good pharmacovigilance practices (GVP) at Replimune and its affiliates as per GxP regulations issued by FDA, MHRA, EMA, and other applicable regulatory bodies. Utilize a broad and diverse background and experience to assist with inspection readiness, regulatory and industry intelligence and risk mitigation plans to assure adherence to applicable GxP regulations and guidelines in the clinical, epidemiological, and post-market setting, to ensure quality and integrity of generated data, oversight of post-market safety activities, and protection of the rights and welfare of subjects/patients.

• Partner with Global Drug Safety and Risk Management (GDS&RM) Business Partners and PV Compliance to ensure ongoing surveillance and compliance of Replimune and its affiliates.
• Execute on a holistic quality assurance model for medical affairs, inclusive of oversight for non-interventional studies, compassionate use programs, medical needs assessments, and medical information requests.
• Develop and survey a data integrity model for the utilization of RWE/RWD, HEOR, data libraries, and general public domain datasets.
• Translate risk factors into quality assurance oversight actions, including internal and external audit strategies and inspection readiness/management strategies.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners and senior management.
• Lead PV and MA vendor quality oversight activities and manage external quality (e.g. quality agreements, set vendor quality councils, etc.)
• Manage GDS&RM related inspections conducted by regulatory agencies, including sponsor inspections, post-marketing Adverse Drug Experience (PADE) inspections, and contract research organization (CRO) inspections
• Oversee the continuous improvement and maintenance of an effective inspection management framework supporting clinical trials and post market pharmacovigilance.
• Act as a primary liaison for Global Product Safety and PV supporting key activities for PSMF compliance, as well as quality oversight of activities related to REMS development, and commercial product safety.
• Engage with cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution.
• Represent the company in interactions with regulatory agencies related to pharmacovigilance and medical affairs.
• Develop and deliver training programs to enhance quality awareness and compliance related to pharmacovigilance and medical affairs across the organization.
• Lead metric analyses for GDS&RM & MA including development and management of KPIs and KQIs for determining the effectiveness of the overall QMS
• Maintain knowledge of agency and industry trends, standards, and methodologies related to GVPs and notify changes to the applicable teams including possible training and ensure the company's quality systems are updated accordingly.
• Engage and influence in external industry consortiums and benchmark opportunities.
  
  
  

Other responsibilities

• Other duties as assigned.

Educational requirements:

• BS or equivalent; advanced degree a plus.
• PhD may substitute for 3 years’ experience

 Experience and skill requirements:

• Minimum 10-15 years (15-20 years for senior director title) progressive PV/MA Quality and/or Compliance experience or relevant BioPharma experience, with demonstrated experience in clinical and commercial PV roles as well as Medical Affairs interactions.
• Extensive knowledge of GCP, GVP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and quality oversight to ensure Replimune complies with regulatory requirements.
• Proven experience in leading and managing teams.
• Strong analytical, problem-solving, and decision-making skills.
• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
• Experience with regulatory inspections and interactions with regulatory agencies.
• Strong leadership and organizational skills, with a commitment to fostering a culture of quality and compliance.
• Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.