Associate Director, Clinical Sciences EU
il y a 4 semaines
Overview of Role:
The Associate Director, Clinical Science is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. This individual will partner with clinical operations, translational, and other matrix team members to design and refine clinical plans, author key clinical/regulatory documents, and ensure exceptional delivery and interpretation of clinical data.
The Associate Director will drive study enrollment and build collaborative relationships with investigators, clinical site staff, CROs, and colleagues. They will foster a proactive approach to clinical study execution, anticipating and effectively resolving obstacles.
Role and Responsibilities:
- Lead/contribute to study design and amendments in collaboration with internal and external scientific stakeholders.
- Collaborate with MD, regulatory, and other internal partners/stakeholders in authoring and submitting protocols, protocol amendments, regulatory filings, and other documentation.
- Work with clinical operations, data management, and CRO to develop and implement the overall data quality plan, leading internal medical data review and safety trend analysis.
- Act as 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/external meetings and communications.
- Partner with clinical operations and CRO to develop and maintain study start-up documents/resources.
- Participate in safety meetings and track, analyze, and review documentation for potential safety events.
- Lead/contribute to the development and implementation of communications strategies for existing and concluded studies.
- Write/review abstracts, posters, and content for scientific meetings and coordinate reviews with internal partners.
- Coordinate submissions to scientific meetings and other appropriate venues.
- Write clinical science sections of meeting packages and assist in developing and reviewing other clinical documentation for regulatory submissions.
- Perform all other duties as assigned.
Experience, Education, and Specialized Knowledge and Skills:
- MS (or equivalent) required; PhD, PharmD, or MD preferred.
- A minimum of 3+ years overall related experience with PhD or like degree.
- Excellent written and verbal communication skills.
- Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data.
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