Senior Manager, Clinical Scientist

Replimune•Woburn, MA

7d•$159,000 - $205,500•Onsite

About The Position

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. Sr. Manager Clinical Scientist, reporting to the (Associate) Director/Sr. Director Clinical Scientist, ensures 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 Clinical Scientist works closely in a matrix with the Medical Director and other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The individual in this position supports the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution.

Requirements

Advanced degree preferred (e.g.: PharmD, PhD, or MD)
Minimum of a Bachelor's degree required
Minimum of 3+ years of experience and success within the function in other biotech / pharmaceutical companies, with 1-2 years in the oncology therapeutic area.
Previous participation in an Early/Late clinical development program is essential.
Clinical oncology experience preferred (Early Phase)/required (Late Phase).
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%
Problem solving and risk-mitigation skills.
Confident, positive attitude, and enthusiastic
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.

Nice To Haves

Demonstrated success in working in a global cross-functional environment is a plus
Experience with the development and support of related SOPs and policies is a plus
Knowledge of industry standard Clinical Development IT solutions expected.

Responsibilities

Facilitate and execute the creation, 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), Annual Reports, and Developmental Safety Update Reports, 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.
Supports 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 for investigator/site staff 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 Medical Director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator
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
In collaboration with the Medical Director/Medical Monitor, build and maintain KOL/investigator networks; organize and present at KOL 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.
Develop, track, execute and report on goals and objectives.
Be accountable for compliant business practices.