Director Clinical Sciences
Director Clinical Sciences
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$ 200000 - 230000
1 Vacancy
Job Description
Overview of Role:
The Director Clinical Science is responsible for leading/contributing to study design and of clinical studies in hematology/oncology. As a leader within the clinical organization this individual 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 Director Clinical Science will strive to drive study enrollment and build and maintain collaborative relationships with investigators and clinical site staff CROs and Summit colleagues. The Director Clinical Science will foster a proactive and thoughtful approach to clinical study where obstacles are anticipated and effectively mitigated/resolved.
Role and 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
- Pointofcontact 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 (e.g. investigator meetings prestudy site selection visits study coordinator or clinical research administrator training study newsletters communications to study sites etc.
- Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g. ICF Lab Manual EDC Safety monitoring Plan etc.
- 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. Includes KOL interactions advisory boards major medical meetings congresses and other events publications and other materials
- Writes and/or reviews abstracts posters content for scientific meetings conferences other events and presentations and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
- Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- All other duties as assigned
Experience Education and Specialized Knowledge and Skills:
- MS (or equivalent) required
- PhD PharmD or MD preferred
- A minimum of 5 years overall related experience with PhD or like degree; Minimum of 2 years experience in conducting / supporting oncology/hematology clinical studies
- Excellent written and verbal communication skills
- Expertise in interpreting immunology/immunooncology translational data in addition to clinical data
The pay range for this role is $200000$230000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Director
Employment Type
Full-Time
