Associate Director, Clinical Research Scientist
The Associate Director, Clinical Scientist role is an exciting opportunity for a highly motivated individual to be a key contributor to the development and execution of the clinical strategy for one or more oncology programs. Through extensive interaction with the Clinical Development Team, this role will have the opportunity to make strategic and scientific impact on current and future clinical programs, building clinical expertise to collaboratively design, plan, implement, analyze, and report clinical studies. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.
- Lead the design of clinical research studies including development of study synopsis, protocol and amendments, study plans and reporting of study results.
- Lead the analysis of information to assess issues relating to protocol conduct and/or individual subject safety.
- Perform regular medical review of individual subjects in collaboration with the medical monitor.
- Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Assist in communicating a clear overview of trial results.
- Lead the clinical contributions to cross-functional documents such as the IB and DSUR.
- Contribute to the authoring and revision of global and regional regulatory submissions.
- Lead special projects such as SOP creation/revision, department template or tool creation, process improvement workstreams.
- Provide support for/Lead global advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery of presentations.
- Lead and mentor more junior level clinical science team members.
- Closely and productively interface with other functions including Clinical Operations, Pharmacovigilance, Data Management, Medical Affairs, Medical Writing, and Regulatory Affairs.
- Perform other duties as assigned.
- 6 – 8 years clinical development experience in the pharmaceuticals/biotech industry or academic institution (clinical science, clinical operations, medical writing, clinical site staff, etc.)
- BS/MS/PhD in a related life science discipline.
- Comprehensive understanding of the drug development process from Phase 1 to Phase 3.
- Prior oncology drug development or oncology patient care experience preferred.
- Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Experience with interacting with medical monitors, development operations (clinical operations, data management, program management, regulatory affairs, medical writing) and clinical investigators.
- Patient profile and data listing review experience.
- Up to date in new clinical trial designs in oncology.
- Strong analytical, problem-solving, and scientific writing skills.
- Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills.
- High level of organizational and project management skills.
- Demonstrated ability to work independently in a matrix environment.
- Demonstrated ability to prioritize and manage multiple tasks simultaneously.
- Demonstrated ability to influence through collaboration.
- Flexibility to accommodate changes in priorities and project needs.
The base salary hiring range for this position is expected to be $144,400 to $187,500 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate’s relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time and our tuition reimbursement program.
Job Location: Remote
Equal Opportunity Employer
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