Senior Manager, Clinical Scientist

Replimune-2; Woburn (MA); On-site; USD 159,000 - 206,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401k Match

Flexible Time Off

Paid Holidays

Job summary

Replimune Group, Inc. in Woburn, MA seeks a Sr. Manager Clinical Scientist to lead clinical development programs, coordinating with Medical Directors, CROs, and external partners to ensure timelines, scope, and compliance. The role supports building global capabilities within the Clinical Development function.

You will review clinical and regulatory documents, contribute to study design, and present data to internal and external stakeholders. Travel ~25% is expected.

Qualifications

• Minimum of 3+ years in biotech/pharma with oncology experience.
• Experience in Early/Late clinical development programs essential.
• Strong communication and cross-functional collaboration skills.
• Knowledge of GCP and ICH Guidelines.
• Willingness to travel ~25%.
• Advanced degree preferred (PharmD/PhD/MD).

Responsibilities

• Create and review clinical and regulatory documents.
• Coordinate with vendors, sites, and CROs.
• Present trial data internally and externally.
• Train staff on therapeutic area and protocol.
• Support medical monitoring and patient eligibility questions.
• Build KOL networks and engage investigators.

Skills

GCP & ICH Guidelines

Clinical Development

Regulatory Documentation

Cross-functional Collaboration

Medical Monitoring

Education

Bachelor's degree

Advanced degree preferred (PharmD/PhD/MD)

Tools

Clinical Development IT solutions

SOPs & policies development

Job description

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.

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.

Key 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.

Educational requirements:

• Advanced degree preferred (e.g.: PharmD, PhD, or MD)
• Minimum of a Bachelor's degree required

Experience and skill requirement:

• 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%
• 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.
• 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.

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 $159,000 -$205,500. 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.