• Facilitate and execute the creation, update, and/or review of key clinical and regulatory documents, including, but not limited to:
  • Protocol concepts, synopses, protocols, and amendments
  • Informed consent documents
  • Investigator Brochures
  • Clinical study reports
  • Abstracts, posters, and manuscripts
  • Clinical sections of INDs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
  • Clinical study supporting documentations and processes, e.g.: charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc
• Supports all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical studies. Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following:
  • Provide clinical and scientific expertise for selection of investigator and vendors
  • Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
  • Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
  • Review, query, and analyze clinical trial data
  • Partner with Medical Director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator
• Present clinical trial data, both internally and externally
• Create clinical study or program-related slide decks for internal and external use
• Represent a clinical study or development program on one or more teams or sub teams
• In collaboration with the Medical Director/Medical Monitor, build and maintain KOL/investigator networks; organize and present at KOL advisory boards and investigator meetings, engage advocacy groups
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Build strong relationships with internal experts
• Develop, track, execute and report on goals and objectives
• Be accountable for compliant business practices

• Advanced degree (e.g.: PharmD, PhD, or MD) within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required

• Minimum of 5+ years of experience and success within the function in other biotech / pharmaceutical companies, with 2-3 years in the oncology therapeutic area
• Previous participation in an Early/Late clinical development program is essential
• Clinical oncology experience preferred (Early Phase)/required (Late Phase)
• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
• Knowledge of GCP and ICH Guidelines
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel approximately 25%

• Demonstrated success in working in a global cross-functional environment is a plus
• Experience with the development and support of related SOPs and policies is a plus
• Knowledge of industry standard Clinical Development IT solutions expected

• Problem solving and risk-mitigation skills
• Confident, positive attitude, and enthusiastic
• Strategic and creative thinker
• Ability to work independently and build working relations throughout the organization and with business partners to achieve business goals
• Strong time management and organizational skills
• Ability to manage multiple projects in a fast-paced environment
• Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc

Replimune is an equal opportunity employer.

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.

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.

Replimune now requires Covid vaccination disclosure for all US employees.