Director, Clinical Scientist

Role Summary

The Director, Clinical Scientist, working in the Late-Stage Clinical Development team, will have a key role in the execution of ADC clinical trials to ensure data quality and integrity. The position will support the clinical development physicians and clinical study team and be responsible for design and scientific conduct of one or more clinical trials. This is a hybrid role and there is a preference for someone locally based near our New Providence, NJ office. Office time would be 1-2 days/month or as needed.

Responsibilities

• Authors Protocol and ICF documents/amendments, presents to development teams as required.
• Works closely with clinical operations and Study Physician to ensure timely execution of trials with utmost focus on quality of data and study integrity
• Works closely with the Study Physician to assure they are informed of pertinent study information, including but not limited to safety and efficacy data.
• Performs data review on an ongoing basis, including data from vendors, AE/SAE reconciliation, etc. and follows data findings to ensure resolution.
• Identifies study and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD.
• Interacts and collaborates with the Safety physician and participates in the periodic safety data review meetings.
• Develops sound, strategic solutions to issues as an integral member of the clinical study team to ensure issue resolution.
• Conducts literature reviews as needed for the interpretation of study data and development of next steps.
• Performs review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
• Establishes and oversees operation of protocol steering committee, data monitoring committee, data safety monitoring board, independent response adjudication committee, etc.
• Writes 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.
• Serves as clinical science representative on cross-function teams as assigned.

Qualifications

• Must have a clinical or science degree (e.g. RN, NP, MSN, PharmD, PhD, MD) in a clinical discipline
• 7+ years of hematology/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.
• Thorough understanding of the oncology drug development process from pre-IND through registration and post-registration 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.
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
• Excellent skills in Microsoft Word/Excel/PowerPoint/Teams, common eCRF systems (e.g. Medidata RAVE) and data review tools (e.g., Pt Profiles, report generating tools).
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, 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.

Education

• No explicit additional education required beyond listed degree; degrees in clinical or scientific fields accepted.

Additional Requirements