Sr. Director, Clinical Scientist

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it. The Senior Director, Clinical Development/Clinical Scientist will report to the VP or Executive Director, of the Early Clinical Development team 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 Senior Director, Early Clinical Development will be accountable to jointly 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.

Responsibilities

Facilitate and execute generation, author, update, and/or review of key clinical and regulatory documents; Contribute to Early Clinical Development Plan Generation and Program Strategy; Serve as primary contact and lead for all clinical and scientific aspects of design, implementation, conduct, analysis, interpretation and documentation of clinical studies; Interpret and present clinical trial data internally and externally; Create clinical study or program-related slide decks; Represent a clinical study or development program on one or more teams or sub teams; Build and maintain opinion leader/investigator networks; Contribute to or perform therapeutic area/indication research and competitor analysis; Build strong relationships with internal experts; Identify continuous process improvement opportunities, best practices and help define/optimize standards and processes; Identify incremental organizational resource needs; Develop, track, execute and report on goals and objectives; Support budget planning and management; Manage and mentor Clinical Scientists; Be accountable for compliant business practices; Other duties as assigned

Requirements

MD, PharmD, or PhD within a clinical and/or scientific profession (or equivalent); Minimum of 12 years of experience and success within other biotech/pharmaceutical companies; Previous participation in a clinical development program including involvement in most stages of clinical trials; Clinical oncology experience; 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%; Demonstrated success in working in a cross-functional environment; Experience with the development and support of related SOPs and policies; Knowledge of industry standard Clinical Development IT solutions; Executive presence; Values based collaborator; 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; Strong and influential leadership skills; Strong time management and organizational skills; Ability to manage multiple projects in a fast-paced environment; Experience with managing direct reports; Skilled in multiple computer-based tools

Nice to have

Taken at least one study from start to finish in a clinical scientist or similar role; Exceptional experience in other therapeutic areas with clear potential to apply to oncology

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown