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Senior Medical Director – Woburn, MA

Reporting into the Chief Medical Officer, the Senior Medical Director will be responsible for assisting the CMO in implementing the Replimune drug development strategy and will lead all aspects of individual drug programs. The Senior 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 a strong outward facing presence and will support investigator-related and investigator-initiated initiatives and assist in the site evaluation and selection process for clinical trials. The position will also have access to pre-clinical data and assist in the implementation of the biomarker strategy as well as interactions with strategic partners. The individual must have the ability to work independently and also 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:

  • Plan and direct all aspects of the organizations medical policies, standards and programs.
  • Understands organizational policies and standard operating procedures
  • Completes all regulatory and compliance training and education
  • Provides oversight for direct reports to maintain compliance within responsible programs
  • Provides input into new policies and helps implement mandated compliance procedures, as appropriate.
  • Develop strategic clinical relationships with physicians and clinical investigators
  • Assists with evaluation and selection of potential study sites
  • Assists with evaluation and review of investigator—initiated pre-clinical and clinical proposals
  • Helps interact with strategic partners within academia, government and industry to promote Replimune’s image and foster effective collaborations
  • Assists the CMO in organizing, moderating and reviewing advisory boards and scientific expert panels
  • Provides leadership and management supervision for individual drug development programs at Replimune
  • Serves as leader of specific drug programs within the Replimune pipeline
  • Builds an effective and efficient program team to move specific agents from early phase clinical development to registration
  • Identifies efficiency gaps and helps to find resources to effectively implement clinical protocols
  • Provides analysis and review of clinical data to help make decisions
  • Assists with preparation of clinical data and questions for regulatory authorities
  • Ensure that all clinical programs are in compliance with all applicable regulations
  • Maintains compliance with all applicable federal, regional, and institutional policies and procedures
  • Ensures that all clinical protocols are approved by local ethics boards and biosafety committees, as applicable
  • Identifies gaps in compliance and helps to remediate any issues of non-compliance
  • Helps with review and analysis of patient safety data and implement any protocol changes mandated by safety concerns
  • Investigates and studies current medical practice patterns and clinical pathways
  • Understand sand researches current standard of care that may impact the clinical development strategy
  • Helps identify key areas for clinical development
  • Assists in identifying eligibility criteria for Replimune clinical protocols
  • Assists Medical Affairs in identifying new opportunities for clinical development of Replimune products
  • Provides advice and suggestions to non-medical management areas on patients and clinical related matters and policies
  • Maintains good working relationships with other areas involved in drug development, including regulatory affairs, clinical operations, manufacturing, pre-clinical development and medical affairs
  • Provides timely and accurate information for internal purposes
  • Serves as a clinical expert in the development of clinical documents and educational materials
  • Contributes to scientific and clinical communications
  • Helps develop and complete scientific reports, manuscripts and other educational materials
  • Works with investigators to identify publication and abstract opportunities
  • Helps to identify opportunities for data presentation and Replimune representation at national and international meetings and conferences
  • Provides oversight for internal review of manuscripts and data presentations
  • Assists in activities with academic and government stakeholders
  • Helps prepare written documents for external meetings and review boards
  • May present data at external meetings, as requested
  • Provides team feedback from interactions with academic and government functions
  • Contributes to all educational efforts and patient advocacy outreach
  • Assists in the development of clinical and patients related materials
  • Works with Medical Affairs to develop educational content for physicians and other healthcare providers
  • Works with Medical Affairs to develop a program for patient education
  • May provide presentations to patients and patient advocacy groups, as appropriate
  • Helps implement the Replimune biomarker strategic plan
  • Assists the CMO in developing and implementing a biomarker strategy
  • Understands and reviews potential biomarker assays and helps provide assay validation, when appropriate
  • Ensures proper collection, processing and storage of all Replimune biospecimens
  • Reviews biomarker data and helps provide critical data analysis of the data for decision making and potential publication and/or presentation of the data
  • Helps identify new technology appropriate for Replimune’s biomarker development program
  • Supervisory Responsibilities
  • Assists in recruitment and retention of qualified medical affairs and clinical operations staff as the organization develops, when and if appropriate
  • Completes all mandated Replimune compliance and quality training
  • Assists in training new physicians and other clinical employees
  • May be asked to serve on Replimune internal committees, as appropriate
  • May be asked to serve as a Replimune representative on external committees and foundations, as appropriate

Educational requirements:

  • MD or DO degree

Experience and skill requirement:

  • Minimum of 10+ years of experience in clinical patient care, clinical research or clinical operations
  • Experience within the pharmaceutical industry, CRO consulting, or academia (or combination of above) is preferred
  • Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company
  • Track record of success in building and leading teams; strong managerial skills
  • Leadership skills, including a passion for working within multiple teams and proven ability to achieve results in a matrix organization
  • Proven track record of working cross functionally on strategic planning, as well as creation of a Life Cycle Management plan
  • Direct involvement with full lifecycle development and medical support of successfully marketed biotechnology or pharmaceutical products
  • Expertise establishing, coordinating and chairing Advisory Boards
  • Extensive network in oncology arena
  • Candidates should have the capability for strategic thinking and planning along with operational skill and tactical experience related to clinical research
  • Team oriented, outstanding interpersonal skills, ability to collaborate with others
  • Superb communication skills, ability to effectively present complex medical information to lay audiences (patients’ organizations, grassroots movements, etc.)
  • Ability to maximize budgets and to work in tight timelines and under pressure
  • Genuine concern for patient’s wellbeing and public health
  • Ability to build a department maximizing resources and skills to attract new talent
  • Ability to travel as requested

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.