Clinical Scientist, Senior Director

Company Overview

This biopharmaceutical company focuses on therapeutics for the treatment of cancer.

Title: Clinical Scientist, Senior Director — JO-2208-5803

Therapeutic Area: Oncology

Indication: Breast Cancer

Territory: REMOTE

The individual will apply their scientific expertise to designing and delivering clinical studies and programs in the Oncology (Breast Cancer) field. S/he will collaborate with Clinical Trial Physicians and Managers to ensure scientific excellence in the execution of Breast Cancer trials. The individual may also fill the shoes of the Clinical Trial Lead and coordinate and manage clinical trials from study feasibility to close.

This role reports to the VP of Clinical Operations.

Essential Duties and Responsibilities

• Write Protocol and ICF documents/amendments, present to development teams and governance committee.
• Work closely with the medical monitor to assure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
• Identify study and program issues by reviewing and monitoring emerging clinical data related to safety, efficacy, and PK/PD.
• Develop sound, strategic solutions to issues and collaborate with the clinical study team to ensure issue resolution.
• Conduct literature reviews as needed for the interpretation of study data and the development of the next steps.
• Perform the review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
• Establish and oversee operation of protocol steering committee, data monitoring committee, data safety monitoring board, independent response adjudication committee, etc.
• Write content for program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• Develop presentations and communicate study data results to colleagues internally and to external audiences, including investigators at sponsor meetings or general audiences at scientific conferences.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into the clinical trial development strategy.
• Serve as clinical science representative on cross-function teams as assigned.

Qualifications (Education & Experience)

• A clinical or science degree (e.g., RN, NP, MSN, Pharm.D., Ph.D., M.D.) in a clinical discipline.
• Significant experience and knowledge of breast cancer drug development, treatment landscape, and clinical trial conduct are required.
• 5-10 years of oncology clinical research experience in planning, executing, reporting, and publishing studies within the pharmaceutical industry.
• Demonstrated ability to review and summarize oncology study data, including experience in preparing and presenting data.
• A thorough understanding of the oncology drug development process from pre-IND through registration and post-registration is required.
• Broad understanding of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization) in oncology.
• Ability to understand, interpret, and communicate clinical information, including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy of oncology products.
• Successful track record of interpreting, analyzing, and presenting oncology clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
• Hands-on experience performing a systematic literature search, summarizing the search results, and presenting the conclusions to a wide spectrum of audiences.
• Excellent skills in Microsoft Word/Excel/PowerPoint, common eCRF systems, and data review tools.
• Ability to work effectively in a collaborative team environment.
• Strong organization, documentation, and communication skills with an ability to multitask.
• Willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines, and current US FDA regulations.

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