About this role
Overview
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.
At Replimune, we live by our values
United: We Collaborate for a Common Goal.
Audacious: We Are Bold.
Dedicated: We Give Our Full Commitment.
Candid: We Are Honest With Each Other.
People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.
Join us, as we reshape the future.
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. The Senior Director, Early Clinical Development 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 cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biometrics, translational medicine, and program leadership.
Key responsibilities
· Facilitate and execute the generation, author, update, and/or review of key clinical and regulatory documents, including, but not limited to:
o Protocol concepts, synopses, protocols, and amendments
o Informed consent documents
o Investigator Brochures
o Clinical study reports
o Abstracts, posters and manuscripts
o Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
o Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
o Risks / benefits analysis for applicable documents
o 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.
· Instrumental to the Early Clinical Development Plan Generation and Program Strategy
· Primary contact and lead 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:
o Provide clinical and scientific expertise for selection of investigator and vendors
o Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
o Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
o Review, query, and analyze clinical trial data
o Serve as medical monitor or partner with (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 sub teams
· Build and maintain opinion leader/investigator networks; organize 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, best practices 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.
· Manage and mentor Clinical Scientists in ensuring roles and responsibilities are performed and met, and staff are appropriately trained.
· Be accountable for compliant business practices.
· Other duties as assigned.
Other responsibilities
· Other duties as assigned.
Educational requirements
· 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.
Experience and skill requirement
· Minimum of 12 years of experience and success within other biotech/pharmaceutical companies (including experience matured in part in high-profile academic institutions).
· 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%
· 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.
· 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.
· Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.
· Strong time management and organizational skills.
· Ability to manage multiple projects in a fast-paced environment.
· Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately.
· Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc.
REVISION HISTORY
Salary Range
Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $256,500-332,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience.
Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
We are an Equal Opportunity Employer.