Director, R&D Quality Assurance Pharmacovigilance

About the Company

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patients’ lives depend on it. At Replimune, we live by our values: United, Audacious, Dedicated, and Candid. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, and a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact the lives of patients, caregivers, and themselves.

About the Role

The Director of R&D Quality-Pharmacovigilance & Medical Affairs is responsible for contributing to the development, implementation, and maintenance of Quality Assurance systems and activities for Replimune’s clinical patient safety, commercial pharmacovigilance (PV) activities, and medical affairs enterprise (including but not limited to observational studies, medical information, and ISTs). This role ensures 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. This includes ensuring the quality and integrity of generated data, oversight of post-market safety activities, and protection of the rights and welfare of subjects/patients.

Responsibilities

• 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.
• 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 Medical Affairs (MA) vendor quality oversight activities and manage external quality (e.g., quality agreements, vendor quality governance).
• 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.
• 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.
• Engage with cross-functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, driving 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, to ensure the company's quality systems are updated accordingly.
• Engage and influence external industry consortiums and benchmark opportunities.
• Other duties as assigned.

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.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
• Understands the big picture, beyond their own functional area. Enterprise thinker.
• Proven problem-solving skills to prevent and overcome complex process and quality-related issues.
• Embraces complexity but strives for simplicity. Keen focus on phase-appropriate and risk-based scientific decision-making.
• Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization.
• Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.

Qualifications

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

Location

This position can be based either in our Woburn office or be a remote role. Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Pay

For this role, the anticipated base pay range is $209,000–$255,000. The exact base pay offered will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor-derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.