Senior Medical Director, Global Drug Safety

Overview

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 patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

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, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

• This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site a minimum of 2 days per week.

Key responsibilities:

• Manage the Medical Directors within the GDS&RM. Support and supervise staff and identify system and resource needs to ensure quality and compliant medical safety evaluation processes
• Oversee the assessment of medical safety information including ICSR’s and aggregate safety data for Replimune’s developmental products
• Lead signal detection and benefit/risk management activities and contribute to the development of pharmacovigilance strategies for monitoring the safety profile of the company’s products
• Lead periodic and ad-hoc SMT and PSRC meetings to review aggregate safety information and signal management for all Replimune products
• Ensure that the safety profiles of Replimune products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required
• Organize and direct liaison cross-functionally with Medical Monitors, Medical writing, Clinical Operations, Data management, Biostatistics, and Regulatory for management of safety reporting in compliance with global and regional regulatory requirements
• Review and provide input on study protocols, statistical analysis plans, safety content of informed consent documents, Investigator and site training documents and presentations
• Contribute to CSRs and analysis of safety tables, figures, and listings and cases from clinical studies
• Support activities related to BLA and other regulatory filings
• Contribute to Regulatory Agency information requests and safety content for regulatory filings, Summary of Clinical Safety and related documents.
• Lead preparation and review of periodic reports (IND, Annual Safety, DSUR, PBRERs, CSR)
• Provide Risk Management Strategy
• Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates
• Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented
• Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally.
• Other responsibilities as assigned

Experience and skill requirement:

• MD or equivalent degree from an accredited medical school
• At least 4 years Clinical practice experience in either an accredited academic setting or private practice (including hospital based) setting
• At least 8 years’ experience in safety and pharmacovigilance in the bio/pharmaceutical industry, including ICSR review, causality assessment, and aggregate data review
• Expertise in oncology, immunotherapy and with viral vectors or other biologic agents preferred
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
• Knowledge of MedDRA dictionary relevant to AE/SAE coding
• Experience with software-based drug safety systems (e.g. ARIS-G and/or ARGUS)
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies.
• Must be able to work on multiple projects simultaneously.
• Ability to prioritize work without much support.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Proficient in standard computer software (Word, Excel and Power Point)

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is$307,000-$397,000. The exact base pay offered for this role 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.

At Replimune, base pay is only one part of your total compensation package. 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 offerings, including, but not limited to, 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

We are an Equal Opportunity Employer.