Clinical Sciences Leadership Role
5 days ago
We are seeking an experienced Associate Director, Clinical Sciences to join our team at Summit Therapeutics Sub, Inc. This role will play a crucial part in leading/contributing to study design and execution of clinical studies in hematology/oncology.
As a leader within the clinical organization, you will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data.
The ideal candidate will have expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data and excellent written and verbal communication skills.
Key Responsibilities- Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
- Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
- Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
- Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
- Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications
- Partners with clinical operations and CRO in developing and maintaining study start up documents/resources
- Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
- Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies
- MS (or equivalent) required; PhD, PharmD, or MD preferred
- A minimum of 3+ years overall related experience with PhD or like degree
- Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
- Excellent written and verbal communication skills
The salary range for this role is $170,000-$190,000 annually, which includes a bonus, stock, benefits, and/or other applicable variable compensation. The actual compensation package will vary based on factors such as skill set, depth of experience, certifications, and specific work location.
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