Senior Director, Clinical Scientist

Replimune

. Report to the VP or Executive Director of Early Clinical Development .

Posted 9/15/2026full-timeWoburn • Massachusetts • United StatesSenior💰 $256,500 - $332,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development program execution, including clinical study design, regulatory compliance, and cross-functional collaboration. Possesses strong leadership and communication skills to effectively manage teams and engage with external partners in the biotech and pharmaceutical sectors.

Highest-signal resume keywords

MD, PharmD, Or PhDClinical Oncology ExperienceGlobal Clinical Study DesignKnowledge Of GCP And ICH GuidelinesExperience Managing Direct Reports

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Development Program ExecutionClinical Study DesignRegulatory Document PreparationClinical Trial Data AnalysisTherapeutic-Area ResearchSOP DevelopmentClinical Trial ManagementBudget Planning And ManagementMedical MonitoringClinical Protocol Training

Soft Skills

Cross-Functional CollaborationInfluencing SkillsProblem-Solving SkillsOrganizational SkillsInterpersonal Skills

Tools & Technologies

Clinical Development IT SolutionsMicrosoft WordMicrosoft PowerPointMicrosoft Excel

Industry Keywords

BiotechPharmaceuticalClinical TrialsRegulatory ComplianceDrug DevelopmentClinical OperationsPharmacovigilanceInvestigator BrochuresINDsNDAs

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Report to the VP or Executive Director of Early Clinical Development
Ensure successful execution of clinical development programs and deliverables across the organization, with external vendors, academicians, and collaboration partners
Jointly develop clinical program strategy and ensure activities are delivered within scope, compliance, budget, and timelines
Help establish and grow Clinical Development functions and global capabilities
Collaborate with clinical development, clinical operations, data management, safety/pharmacovigilance, regulatory, biometrics, translational medicine, and program leadership
Facilitate, author, update, and review clinical and regulatory documents, including protocols, informed consents, Investigator Brochures, clinical study reports, abstracts, posters, manuscripts, INDs, NDAs, annual reports, and safety update reports
Generate Early Clinical Development Plans and program strategy
Lead clinical and scientific aspects of clinical study design, implementation, conduct, analysis, interpretation, and documentation
Provide expertise for investigator and vendor selection
Train internal colleagues, CRO staff, and study site staff on therapeutic areas, molecules, and clinical protocols
Provide scientific and medical support throughout clinical trials and respond to questions from sites, IRBs/IECs, Health Authorities, and CROs
Review, query, and analyze clinical trial data
Serve as medical monitor or partner with medical directors on medical monitoring, patient eligibility, and treatment-related questions
Interpret and present clinical trial data internally and externally
Create clinical study and program slide decks
Represent clinical studies or development programs on teams and sub-teams
Build and maintain opinion leader and investigator networks; organize advisory boards and investigator meetings; engage advocacy groups
Conduct or contribute to therapeutic-area research and competitor analysis
Build relationships with internal experts
Identify process improvements, best practices, and optimized standards and processes
Identify organizational resource needs, including staff, budget, and systems
Develop, track, execute, and report goals and objectives
Support budget planning and management
Manage and mentor Clinical Scientists and ensure training and responsibilities are met
Ensure compliant business practices
Perform other duties as assigned

Requirements

What you’ll need

MD, PharmD, or PhD within a clinical and/or scientific profession, or equivalent level of professional, clinical and/or scientific education, training and experience, required
Minimum of 12 years of experience and success within biotech/pharmaceutical companies, including experience matured in part in high-profile academic institutions
Previous participation in a clinical development program, including involvement in most stages of clinical trials from start-up to study report
Ideally, experience taking at least one study from start to finish in a clinical scientist or similar role
Clinical oncology experience; exceptional experience in other therapeutic areas may be considered with clear potential to apply skills to oncology
Expert understanding of global clinical study design and drug development from discovery to registration and post-marketing
High level of written and verbal communication, interpersonal, organizational, and cross-functional collaboration skills
Knowledge of GCP and ICH Guidelines
Flexibility to work with colleagues in a global setting
Ability to travel approximately 25%; remote candidates must be open to 30% travel to Woburn HQ or as business needs require
Demonstrated success in a cross-functional environment
Experience developing and supporting related SOPs and policies
Knowledge of industry-standard Clinical Development IT solutions
Executive presence
Values-based, respectful, accountable, and collaborative approach
Ability to work with a wide range of people to achieve results
Strong written and verbal scientific communication
Influencing skills across all levels of the organization and external collaborators
Problem-solving and risk-mitigation skills
Confident, positive, enthusiastic, and charismatic approach
Appreciation of diversity and multiculturalism
Strategic and creative thinking
Ability to work independently and build relationships throughout the organization and with business partners
Strong influential leadership skills, with 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 managing direct reports and ensuring appropriate role performance and training
Skilled in computer-based tools including Word, PowerPoint, and Excel

Benefits

Comp & perks

Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical insurance
Dental insurance
Vision insurance
401(k) match
Flexible time off
Paid holidays, including year-end shutdown
Remote work option
Professional and career development through work with cross-functional teams and clinical development programs