Associate Director, Clinical Research Scientist

Responsibilities

• 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.

Qualifications

• 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.