Director, Clinical Project Scientist
il y a 7 jours
Essential Functions:
- Executes clinical research strategies and contributes to the development and execution of clinical research programs
- Directs end to end delivery of clinical studies
- Defines clinical study parameters, supports deliverables, policy compliance and resource needs
- Serves as a clinical point of contact for cross functional teams and program level workstreams
- Reviews, evaluates, interprets results of clinical trial data preparation for submission and assists with interactions with regulatory health authorities
- Leads and performs medical monitoring/reporting, evaluates ongoing clinical trial data
- Manages and provides oversight on trial results
- Assists with development of clinical research protocols, study case report forms, informed consent forms
- Organizes documentation needed for data collection, analysis
- Reviews and maintains protocol specifications in alignment with standard operating procedures
- Guides and mentors less experienced team members in adherence to clinical research guidelines and safety procedures
- Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
- Communicates detailed outcomes and results of research findings to relevant partners
- Anticipates areas of opportunity to ensure delivery of a quality database and contributes to data quality process improvements
- Presents research status at internal/external meetings, including investigator meetings and company sponsored events
- May lead one or more program or therapeutic area initiatives
- Works with high level of autonomy, providing decision accountability for project, owns escalations, and communicates effectively at all levels, including senior stakeholders
- Experience developing, presenting, and leading clinical data discussions
- Mentorship of less experienced team members and may have direct reporting/people management accountability
**Principal Relationships**:
Contacts within the Company:
- Members of the Clinical and Cross Functional Trial teams
- Members of Oncology TA
- Cross Functional Senior Management
Contacts outside the Company:
- May act as a liaison, in partnership with Global Operations and Study Responsible Physician, between company and Investigators, Site Managers, Site staff, global clinical research staff, vendor project managers, and CROs
- Develops credible relationships with senior leaders, opinion leaders, medical directors, and key regulatory officials
**Qualifications**:
- Minimum of a bachelor’s degree in a scientific discipline required, with advance degree (i.e., MSc, Ph.D., or Pharm D) preferred
- A minimum of 8 years of progressively responsible experience in clinical research, or related experience within the industry (pharmaceutical, biotech, CRO, etc.) is required.
**Required Technical Knowledge or Skills**:
- High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
- Successful independent ability to navigate in a matrix team environment with global cross functional teams is required
- Fluent in written and spoken English with excellent oral and written communication skills
- Working knowledge of the use of Microsoft suite of software products
- Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality oncology clinical trials including protocol development, medical review, oversight of safety, study conduct, and data quality
- Ability to travel approximately 10-20% domestic/international travel may be required
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