Director, Clinical Scientist
About The Position
The Director, Clinical Scientist leads and contributes to the design and execution of hematology/oncology clinical studies. As a leader in the clinical organization, this role partners with clinical operations, translational, and other matrix team members to develop and refine clinical plans, author key clinical and regulatory documents, and ensure high-quality delivery and interpretation of clinical data. The Director works to support study enrollment and maintain collaborative relationships with investigators, clinical site staff, CROs, and Summit colleagues. The role promotes proactive study execution by anticipating and resolving obstacles. The position supports Summit’s clinical programs, including a randomized Phase 2/3 study of ivonescimab with enfortumab vedotin versus pembrolizumab with enfortumab vedotin in previously untreated locally advanced or metastatic urothelial carcinoma. Responsibilities also include study data review and safety analysis, scientific communications, and clinical documentation for regulatory processes.
Requirements
- Master’s degree or equivalent required.
- At least 5 years of overall related experience with a PhD or like degree.
- At least 2 years of experience conducting or supporting oncology/hematology clinical studies.
- Excellent written and verbal communication skills.
- Expertise interpreting immunology/immuno-oncology translational data in addition to clinical data.
Nice To Haves
- PhD, PharmD, or MD.
Responsibilities
- Lead or contribute to study design and amendments in collaboration with internal and external scientific stakeholders.
- Collaborate with medical, regulatory, and other internal partners on authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documents.
- Collaborate with clinical operations, data management, and CRO teams to develop and implement the overall data quality plan; lead internal medical data review and safety trend analysis for one or more studies or programs.
- Serve as a point of contact for clinical inquiries from CRO medical monitors and other stakeholders.
- Develop and provide input for clinical presentation slides and materials for internal and external meetings and ongoing communications, including investigator meetings, site-selection visits, training, study newsletters, and communications to study sites.
- Partner with clinical operations and CRO teams to develop and maintain study start-up documents and resources, such as informed consent forms, lab manuals, EDC, and safety monitoring plans.
- Participate in safety meetings and track, analyze, and review documentation for potential safety events.
- Lead or contribute to communications strategies for ongoing and completed studies, including KOL interactions, advisory boards, medical meetings, congresses, publications, and other events and materials.
- Write or review abstracts, posters, scientific meeting and conference content, presentations, and other publicly distributed materials; coordinate further reviews with internal partners and stakeholders.
- Coordinate submissions to scientific meetings and other appropriate venues or groups.
- Write clinical science sections of meeting packages and assist in developing and reviewing clinical documentation for regulatory submissions and processes.
- Perform other duties as assigned.
Benefits
- The total compensation package may include bonus, stock, benefits, and/or other applicable variable compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Director
