Senior Medical Director, Clinical Development

Overview The Senior Medical Director, Clinical Development 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 Sr.

Medical Director 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 incumbent 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 Sr Medical Director 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.

This position can be based either in our

Woburn office or be a remote role

Our Woburn location welcomes hybrid work

Local candidates are expected to be on-site 2 days per week.

Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to travel to our Woburn HQ, every 4-6 weeks or as business needs require.

total travel can be up to 25-30% including conferences and site visits

Responsibilities

Contributes to the overall clinical strategy for all or select RP1 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 clinical trials programs, including the prioritization of investigator sponsored studies in the context of the overall clinical strategy, and literature reviews.

Collaborate with Medical Affairs on the development of educational materials intended for all stakeholders, including healthcare providers and patients, that is medically accurate and

Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking

Ensure the consistent application of state-of-the-art scientific and ethical methods to design clinical investigational trials of the highest

Help assure that all activities within clinical development are executed compliantly and to global industry standards as well as within expected scope, budget and

Collaborate with colleagues in research and preclinical development functions to move product candidates from entry into clinical

Actively support business development to evaluate product candidates, determine product indications and assist in related strategic planning and partnering

Other responsibilities:

Completes and maintains Compliance training; provides input on new initiatives and makes recommendations on new compliance procedures; assists in the development of compliance and quality training

Will work with commercial to develop a commercialization strategy which will include development of TPPs based on competitive assessment and target positioning and will align the clinical development strategy with the commercial strategy, and may include the design of post-marketing studies, as

May be asked to serve on Replimune internal committees, as a Replimune representative on external committees and foundations

Assists with the recruitment of new employees, mentors junior team members, contributes to relevant training materials, as well as provides guidance and assistance in new hires’ professional

Other duties as assigned

Qualifications Educational requirements:

A medical degree (M.D.) required, additional science degree (PhD) desirable but not required. Training and experience in oncology and immunotherapy is required. Oncology board certification preferred but not required.

Experience and skill requirements:

7+ years of global clinical development experience and success within other biotech / pharmaceutical

Professional knowledge and skills working with solid tumor oncology (minimum of 3 years experience is required for the Executve Medical Director)

Must possess a high level of understanding of the fundamentals of clinical development, such as experience with protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database

Demonstrated experience in designing development strategies (including role of biomarkers) and leading Phase 1-3 programs coupled with the appropriate regulatory and commercial experiences of successful oncology drug product approval and

Proactive, creative, forward-thinker with the ability to think innovatively about integrated strategy for research, clinical and commercial activities, while accurately anticipating future consequences and

Knowledge of all the requirements and processes needed to take a drug candidate through clinical development to registration

Experience in late stage medical affairs and commercial environments, including the planning of and participation in pre-commercial activities for late stage to commercial products

Demonstrated familiarity with biostatistics principles used in the analysis and interpretation of clinical trial

Familiarity with and ability to interface effectively with appropriate Key Opinion Leaders (KOLs), investigators, CROs, and other

Excellent written and verbal scientific communication skills and analytical

Knowledge of applicable International Compliance guidelines and regulations, FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug

Experience in representing the sponsor in front of regulatory

Knowledge of the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; working closely with Pharmacovigilance on processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).

Prior experience with vendor selection and management is

Experience with the development and support of related SOPs and policies is

Experience with partnerships and strategic alliances is

Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel,

Domestic and international travel (up to approximately 30%) is required

Location Requirement

This position can be based either in our

Woburn office or be a remote role

Our Woburn location welcomes hybrid work

Local candidates are expected to be on-site 2 days per week.

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.

Replimune is an equal opportunity employer.

Replimune now requires COVID vaccination disclosure for all US employees.

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