Clinical

• Contributes to the overall clinical strategy for all or select RP programs from early development, through regulatory submissions and post-commercialization, with an emphasis from mid to late stages of development.
• 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 experts.
  • 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 amendments.
  • Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
  • Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study teams.
• 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 delivery.
  • 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 strategy.
• 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 questions.
• Ensures that all the activities and clinical programs are in compliance with the GCP and regulatory requirements, as well as local and institutional requirements.
• 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 agencies.
• Work with program management to assure deep integration of objectives, achievement of milestones according to the timelines, and optimal use of resources across functions.
• 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 appropriate.
• Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.
• Ensure the consistent application of state-of-the-art scientific and ethical methods to design clinical investigational trials of the highest quality.
• Help assure that all activities within clinical development are executed compliantly and to global industry standards as well as within expected scope, budget and timelines.
• Collaborate with colleagues in research and preclinical development functions to move product candidates from entry into clinical investigations.
• Actively support business development to evaluate product candidates, determine product indications and assist in related strategic planning and partnering discussions.

• 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 materials.
• 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 appropriate.
• 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.
• 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 development.
• Other duties as assigned.

• 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.

• 7+ years of global clinical development experience and success within other biotech / pharmaceutical companies.
• Professional knowledge and skills working with solid tumor oncology therapeutic.
• 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 lock.
• 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 launch.
• 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 trends.
• Knowledge of all the requirements and processes needed to take a drug candidate through clinical development to registration preferred.
• 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 preferred.
• Demonstrated familiarity with biostatistics principles used in the analysis and interpretation of clinical trial data.
• Familiarity with and ability to interface effectively with appropriate Key Opinion Leaders (KOLs), investigators, CROs, and other entities.
• Excellent written and verbal scientific communication skills and analytical abilities.
• Knowledge of applicable International Compliance guidelines and regulations, FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
• Experience in representing the sponsor in front of regulatory agencies.
• 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 expected.
• Experience with the development and support of related SOPs and policies is expected.
• Experience with partnerships and strategic alliances is expected.
• Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.
• Domestic and international travel (up to approximately 30%) is required.

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.

• Functions as internal Data Management Study Lead, responsible for all data management activities performed by internal and external study team members to ensure data integrity, quality, and timeliness is protected.
• Works to ensure on-time achievement of CDM deliverables and milestones.
• Performs weekly review of clinical and vendor data metrics to ensure timely communication of significant data trends to the cross-functional study team and CROs.
• Provides presentations with MS PowerPoint slides during department and study meetings to describe study status, risks, successes, critical metrics, and necessary trainings.
• Proactively escalates critical issues and risks to the study and CDM leadership, tracking each item to a resolved state.
• Reviews and provides input into Protocol and other clinical study documents during development and through each amendment.
• Reviews and provides development input into all CRO generated CDM documentation, such as the Data Management Plan, CRF Completion Guidelines, Data Review Plan, Data Transfer Plans, Data Reconciliation Plans, and other similar files, before providing approval for distribution.
• Performs QC of CRO vendor data and SAE reconciliation to provide CRO feedback and negotiate timelines for resolution with the cross-functional process owner.
• Leads and participates in cross-functional data review activities.
• Executes Project Management and quality oversight for all EDC change management including Protocol Amendment change impact assessment, CRF specifications, Edit Check specifications, CRO QC and validation activities, Sponsor-UAT, and timeline management.
• Develops and manages the delivery of data report and listing specifications for data cleaning and Sponsor-clinical data review activities.

• Bachelor’s degree in scientific/technical discipline is required.
• At least 5 years of CDM experience.
• A minimum of 1 year in Sponsor-level Oncology data management.
• Demonstrated experience in leading Oncology data deliverables to successful completion.
• Strong project management skills and ability to lead and collaborate effectively with cross-functional teams.

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.

• Collaborate with internal and external functions to plan and execute programming deliverables.
• Develop and execute statistical analysis and reporting deliverables in a timely and high-quality manner. 
• Review or author SDTM and ADaM datasets specifications for datasets programming.
• Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for ADaM datasets, fit-for-purpose analysis, and TLFs.
• Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
• Provide programming support for adhoc analysis and for preparation of publications, including manuscripts and posters etc.
• Review key study-related documents including but not limited to SAP, annotated case report form, data management plan, database specifications, EDC data structures specs.
• Participates in the development of overall objectives and influences long-term goals of the team.
• Other duties as assigned.

• Bachelor’s degree in Life Science, Statistics, Mathematics, or Computer Sciences is required.  Master’s degree preferred.

• Minimum of 12 years of SAS programming experience within a Pharma / Biotech or CRO.
• Solid SAS programming skills and experience with CDISC, SDTM, ADaM and Pinnacle 21. Good programming skill in MACRO is needed.
• Experience in the analysis of complex oncology clinical trial data. Knowledge of immuno-oncology is a plus.
• Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH).
• Strong knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.).
• Prior experience filing a BLA or NDA preferred.
• Ability to manage multiple initiatives and shift priorities within a small company environment.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.

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.

• 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.

• Manage or assist in managing study execution, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial.
• Contribute/establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
• Proactively identify risks, offer mitigation strategies and support implementation
• Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
• May oversee investigator recruitment/ selection across project
• Participate in ad hoc clinical operations’ initiatives and programs.
• Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.
• Contributes to the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, project management plans, communication plans, and quality plans
• Oversight of clinical monitoring to ensure that all outstanding site issues are closed out in a timely manner (if applicable).
• Participate in the forecasting of Investigational Medicinal Product and clinical trial related supplies.
• Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews
• Ensure that the Trial Master File (TMF) is set up and maintained throughout the trial in compliance with ICH/GCP and company SOPs, including conducting periodic risk based reviews to ensure all appropriate documents are filed.   
• Assist with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
• Participate/provide assistance with responding to Quality Assurance audits and/or regulatory authority inspections
• Assist with ongoing study communication and escalation of study-related issues as required.

• Participates in meetings with investigator sites, key opinion leaders and consultants as needed.
• Facilitate the development of clinical trial agreements and other relevant documents.
• Contribute to request, creation and review of scope of work and budgets; participate in vendor performance management and issue resolution.
• Review and provide input for site budgets, manage clinical trial budget, providing ongoing financial reporting and projections to finance.
• Reconciliation and reporting for vendor and site invoices, payments and change orders, ensuring accuracy and timely delivery
• Work cross-functionally to ensure clinical program timelines and goals are met.
• May participate in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits
• May provide study-specific mentoring for junior team members, as appropriate.
• Participate in operational improvement initiatives (e.g. SOP development, training, etc.).

• Bachelor’s degree in health sciences or related field.

• Minimum of 5+ years’ experience in clinical research with at least 2 years’ experience in study management. Clinical Monitoring preferred.
• Experience in management of CROs, vendors and consultants.
• Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required.
• Proficient written and verbal communication skills.
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Therapeutic (oncology) or medical knowledge preferred.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
• Position may require some travel.

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.