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. We are continuing to grow our executive team and looking to have a new VP of Clinical Development join our Woburn team!
Summary of job description:
The Vice President of Clinical Development will report to the Chief Medical Officer. In this capacity, the VP of Clinical Development will be responsible for the development and execution of a comprehensive clinical development strategy of all clinical assets from early to late stage development, product approval and life cycle management, in collaboration with the clinical development teams. As a member of the senior management team, the VP CD provides medical and scientific expertise in assessments and decisions affecting the company’s clinical development programs.
The VP CD is expected to guide and develop the company’s team of clinical development and supporting staff, consultants and advisors and collaboratively work with senior and functional leaders to ensure fully harmonized and integrated development strategies to advance and expand Replimune’s portfolio of products. This position will have direct and indirect supervisory responsibilities for medical directors and clinical scientists.
The VP CD is expected to develop and maintain relationships with KOLs on a global scale, represent Clinical Development internally to senior management and at at governance committees, as well as externally to KOLs, patient advocacy groups, lead governance committees responsible for the oversight of scope, schedule, resources of the programs and for the recommendation of strategic context and priorities to senior management. This is an integral role in the provision of successful product development and scientific and commercial excellence in support of Replimune’s drug development efforts.
This role requires an experienced and innovative leader capable of developing and implementing an integrated strategy to support clinical development, regulatory filings and initial market launch of innovative oncolytic immuntherapy treatments for cancer.
- As a member of the senior management team, help build, develop, lead and drive the strategy of Replimune’s clinical pipeline, including prioritization and acceleration of Replimune’s drug candidates in a manner that ensures scientific value creation across lifecycle including initial approval, launch, lifecycle indications.
- Provide leadership and guide the overall clinical strategy for all programs from early development, through regulatory submissions and post-commercialization, with an emphasis from mid to late stages of development.
- Drive and execute the clinical activities that lead to successful IND and NDA/MA filings for new cancer therapies.
- Responsible for clinical development strategies including Phase I through IV global oncology clinical trials, lifecycle management, medical interactions with regulatory bodies, and interactions with any collaborative partner(s). Key Contributor to the medical/scientific input for multi-disciplinary team activities.
- Oversee and/or directly design and author study protocols and related clinical documents.
- Work with Data Management, Medical Safety and Pharmacovigilance, Medical Directors 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. Oversee and direct the interpretation of clinical and translational study data.
- Define the clinical actions, assign clinical resources, and work closely with clinical operations on clinical budget, monitoring of project status, and identifying risks and mitigations of clinical trial execution. Work with program management to assure deep integration of objectives, achievement of milestones according to the timelines, and optimal use of resources across functions.
- Responsible for guiding the clinical development team on the preparation of global clinical development plans, providing medical input to investigator’s brochures, briefing books, safety updates, IND/BLA submission documents, and responses to Health Authorities questions.
- Aid in the design and implementation of safety strategies for clinical studies, including regular review of safety data and responses to safety issues, in collaboration with Replimune’s medical safety and pharmacovigilance team.
- Lead and oversee the definition and tactical development of clinical trials programs, including the prioritization of investigator sponsored studies in the context of the overall clinical strategy, and literature reviews.
- In partnership with Medical Affairs, oversee 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.
- Ensures 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.
- Work with the Regulatory team and other crossfuncitonal 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.
- Collaborates with colleagues in research and preclinical development line 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.
- May 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.
- Identify continuous process improvement opportunities.
- Assure consistent and rigorous approaches across all programs
- Develop, track, execute and report on goals and objectives.
- Other duties as assigned.
- A medical degree (M.D.) required. Training and experience in oncology and immunotherapy is required. Oncology board certification preferred but not required.
Experience and Skills Requirements:
The successful candidate must have extensive senior-level experience in clinical development, ideally with both larger pharmaceutical as well as with biotechnology companies. This person is expected to have a thorough understanding of all the requirements and processes needed to take a drug candidate through clinical development to registration. It will be desirable if this person also has 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.
- Minimum of 10 years of experience and success within other biotech / pharmaceutical companies or equivalent experience in academia.
- Professional knowledge and skills working with solid tumor oncology therapeutics is required.
- 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.
- Strategic leader with demonstrated success building, managing and developing individuals and teams is required.
- 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
- Prior experience at senior levels working in and/or leading cross-functional teams.
- Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
- Works effectively with executive team peers to advance innovative therapies for unmet patient needs.
- Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.
- Strong external presence with excellent written and verbal communication skills.
- Stature, credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal and external stakeholders.
- Working knowledge of applicable International Compliance guidelines and regulations is expected.
- Excellent working knowledge of 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.
- Solid management skills with a history of leading others to success and a good reputation for managing high performance teams.
- Hands-on style with proven ability to work in an entrepreneurial environment and ability to manage and outsource work as required.
- 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).
- Experience working in global environment is required.
- Prior management of budgets is expected.
- 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.
- Ability to relate and work with a wide range of people to achieve results.
- Impactful written and verbal scientific communication skills.
- Successful and superior influencing skills across all levels of the organization and with external collaborators.
- Problem solving and risk-mitigation skills.
- Ability to 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, Project, PowerPoint, Excel, etc.
- Ability to travel approximately 25% of time.
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.