- 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.
Experience and Skill Requirements:
- 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.
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.
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.