Replimune’s mission is to discover and deliver a new generation of cancer treatments called oncolytic immunotherapies. Oncolytic viruses combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, and generating a robust patient-specific, systemic anti-tumor immune response. Oncolytic immunotherapy is expected to strengthen the effectiveness of immune checkpoint blockade and become the second cornerstone of immune-oncology approaches, moving beyond the incremental improvement in cancer treatment to help more patients overcome their disease.
The Associate Director – Clinical Development will support Replimune to ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The successful candidate will report to the Senior Director or CMO, Clinical Development.
The candidate will be accountable to help develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The candidate will play a key role in the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution. Specifically, the candidate will work closely with colleagues in clinical development, clinical operations, safety/pharmacovigilance, regulatory, biometrics, biomarkers and translational research, and program leadership.
- Minimum of 5 years of experience and success within other biotech/pharmaceutical companies.
- Previous participation in a clinical development program is essential, including involvement in most stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist or similar role.
- Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology.
- Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.
- 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% or less
- Demonstrated success in working in a cross-functional environment
- Experience with the development and support of related SOPs and policies is expected.
- Knowledge of industry standard Clinical Development IT solutions expected
Capabilities and Competencies
- Executive presence.
- Values based collaborator – respectful, accountable and collaborative.
- Ability to relate and work with a wide range of people to achieve results.
- Impactful written and verbal scientific communication.
- Successful and superior influencing skills across all levels of the organization and external collaborators.
- Problem solving and risk-mitigation skills.
- Confident, positive attitude, enthusiastic and charismatic.
- Appreciation of diversity and multiculturalism.
- 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.
Essential Functions of the job:
- Facilitate and execute the generation, author, 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), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
- Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
- Risks / benefits analysis for applicable documents
- 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.
- Contribute to the Clinical Development Plan Generation and Program Strategy
- Accountable for 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 and support (senior) medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator
- Interpret, and 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 subteams
- Contribute and present at key opinion leader 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.
- Identify continuous process improvement opportunities and help define/optimize standards and processes.
- Identify incremental organizational resource needs – staff, budget, and systems.
- Develop, track, execute and report on goals and objectives.
- Support budget planning and management.
- Be accountable for compliant business practices.
MD, PharmD, or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
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.