Careers

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Medical Director

Department: Medical Affairs
Reports to: Chief Medical Officer
Location: Woburn Office

Summary of Job Description:
Reporting into the Chief Medical Officer, the Medical Director will be responsible for assisting the CMO in implementing the Replimune drug development strategy and will lead the clinical aspects of individual drug programs. The Medical Director will provide clinical input on clinical protocol development, regulatory issues, 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. This position 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. The position will also have access to pre-clinical data and assist in the implementation of the biomarker strategy for assigned trials.  The individual must have the ability to work independently as well as work as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Key Responsibilities:

  • Serve as clinical lead on assigned clinical trials
  • Provide medical input to project teams, as requested
  • Work with other teams, such as clinical operations, regulatory, biostatistics, manufacturing, to implement assigned clinical trials
  • Clinical monitoring of one or more studies
  • Data review and cleaning of ongoing studies
  • Addresses relevant clinical queries from study sites
  • Identify and builds relationships with investigators
  • Contributes to DSURs and PSURs
  • Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
  • Can work consistently in a matrix environment
  • MD preferably with a background in clinical oncology with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.

Job Requirements:

  • Responsible for the clinical aspects of assigned clinical trials from site(s) initiation to study discontinuation
  • Ability to conduct all the activities in compliance with the GCP and regulatory requirements
  • In collaboration with other relevant teams, designs and implements safety monitoring plans
  • Interprets clinical data and makes appropriate decisions and recommendations
  • Addresses relevant clinical queries from study sites
  • Contributes to responses regarding study related regulatory and IRB questions
  • Works with relevant teams to author clinical protocols and related documents, including clinical study reports, clinical regulatory documents including integrated summaries and clinical overview.
  • Identify and builds relationships with study investigators
  • Is seen and acts as the study expert by the site personnel
  • Ability to work and communicate efficiently with internal partners
  • Identify and builds relationships with principal investigators
  • Maintain a strong medical/scientific reputation within the disease area
  • Contribute to Health Authority interactions as a Medical Monitor on assigned clinical studies
  • Manage communication with key senior stakeholders (senior)

Educational Requirements:

  • MD or DO Degree

Experience and Skill Requirements:

  • Understanding of the fundamentals of clinical development (e.g. from working in a similar or an adjacent group in industry)
  • Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
  • Has a history of handling multiple, complex, studies in parallel
  • Has a history of prior meaningful participation in regulatory submissions
  • Has a history of strong interaction with thought leaders
  • Proven team leadership capability

 



EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.


Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.