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Senior Medical Director
Summit Therapeutics, Inc.. Provide medical affairs and clinical development leadership, including medical oversight of clinical studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development and medical affairs, particularly in hematology/oncology, with a strong focus on regulatory interactions, clinical trial execution, and cross-functional collaboration. Proficient in developing product strategies and communicating complex scientific information effectively.
Highest-signal resume keywords
MD Board CertificationHematology/Oncology Product Development ExperienceClinical Development Pathways KnowledgeClinical Trial Execution LeadershipFluent in English and European Languages
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical DevelopmentRegulatory InteractionsClinical Trial DesignAdverse Event MonitoringData AnalysisProtocol AdherenceSafety ReviewsClinical Study ReportsPublications DevelopmentOncology Treatment Expertise
Soft Skills
Clear CommunicationOrganizational SkillsCritical ThinkingProblem SolvingAttention to Detail
Tools & Technologies
MS Office SuiteElectronic Document Management SystemsDocument Review Tools
Certifications & Qualifications
Board Certified MD
Industry Keywords
Pharmaceutical R&DBiologicsBiotechFDAEMAClinical Development ProgramsBLA ApprovalsHematology/Oncology TherapeuticsClinical OperationsBiometrics
About the role
Key responsibilities & impact- Provide medical affairs and clinical development leadership, including medical oversight of clinical studies
- Obtain scientific advisory input and work with external clinical investigators
- Support regulatory interactions for product advancement
- Collaborate with clinical operations on medical input and operational decision-making
- Serve as a key medical expert for multiple cross-functional teams
- Apply oncology treatment and management expertise to Summit medicines’ strategy and clinical development
- Develop overall product strategy across multiple indications with Medical Affairs, Regulatory, Commercial, and other functions
- Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to complete clinical development programs leading to BLA approvals
- Lead clinical trial execution, clinical development strategy, and medical affairs planning
- Contribute to product communications through publications, manuscripts, abstracts, posters, and scientific presentations
- Contribute to two or more pivotal clinical development programs
- Direct Phase 1–3 human clinical trials and help achieve development milestones and enrollment goals
- Review adverse event reports and monitor safety data, evaluating and escalating safety signals
- Coordinate information for reports submitted to FDA, EMA, PMDA, government, regulatory, or partner agencies
- Present to regulators, governing and harmonization bodies, principal investigators, scientific conferences, advisors, and opinion leaders
- Support clinical trial planning and execution, including protocol adherence, safety reviews, assay development, training, and clinical document review
- Plan, review, and edit Clinical Study Reports
- Plan, review, and edit program publications
- Provide input on clinical study design supporting clinical strategy
- Perform other duties as assigned
Requirements
What you’ll need- Board certified or eligible MD with hematology/oncology product development experience across stages of clinical development
- Minimum of 5+ years’ experience in a pharmaceutical, biologics, or biotech R&D environment, or research environment involving collection and analysis of human data in hematology/oncology
- Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
- Fluent in English and at least one or more other European languages (French, Spanish, German, Italian, etc.)
- Proficient user of standard MS Office suite, such as Word and Excel
- Experience using electronic document management systems and document review tools desirable
- Strong computer and database skills
- Attention to detail, accuracy and confidentiality
- Clear and concise oral and written communication skills
- Excellent organizational skills
- Critical thinking, problem solving, and ability to work independently
- Ability to multitask and manage time-sensitive and highly confidential documents
- Ability to communicate complex ideas clearly
- Ability to prioritize conflicting demands
- Ability to work in a fast-paced, demanding, and collaborative environment
- Willingness and ability to travel for investigator engagement, face-to-face interaction, and protocol training
Benefits
Comp & perks- Potential bonus
- Stock
- Benefits
- Variable compensation may be included in the total compensation package
- Remote work arrangement