Director, Clinical Scientist

Role Summary

Director, Clinical Scientist roles in late-stage clinical development, responsible for design and scientific conduct of one or more ADC clinical trials, ensuring data quality and integrity. Hybrid role with preference for local candidate near New Providence, NJ; office time 1-2 days per month.

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 focus on data quality and study integrity.
• Keeps Study Physician informed of pertinent study information, including safety and efficacy data.
• Performs ongoing data review (vendors, AE/SAE reconciliation, etc.) and follows findings to resolution.
• Identifies study and program issues by reviewing emerging clinical data related to safety, efficacy and PK/PD.
• Collaborates with Safety physician and participates in periodic safety data review meetings.
• Develops strategic solutions to issues as an integral member of the clinical study team.
• Conducts literature reviews for interpretation of study data and next steps.
• Performs review, analysis, and interpretation of study results and ensures accurate data reporting.
• Establishes and oversees operation of protocol steering committee, data monitoring committee, DSMB, independent adjudication committees, etc.
• Writes content for program documents including clinical sections of INDs, CSRs, investigator brochures, annual reports, and regulatory submissions.
• Serves as clinical science representative on cross-functional 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 preparing and presenting data.
• Thorough understanding of the oncology drug development process from pre-IND through registration and post-registration.
• Broad understanding of drug development (preclinical, regulatory, pharmacovigilance, drug supply, data sciences, and clinical operations in oncology).
• Ability to interpret and communicate clinical information to support a robust clinical development strategy for oncology products.
• Understanding of trial design and statistics to apply to clinical protocol design.
• Excellent skills in Microsoft Word/Excel/PowerPoint/Teams, eCRF systems (e.g., Medidata RAVE) and data review tools.
• Ability to work effectively in a collaborative, influence-based team environment.
• Strong organization, documentation, and communication skills with multitasking ability.
• Adaptable and flexible with the ability to manage multiple demands and shifting priorities.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Skills

• Clinical trial design and execution
• Data review and interpretation
• Regulatory documentation and submissions
• Cross-functional collaboration
• Scientific writing and communication
• Program and committee governance (DSMB, steering committees)

Education

• Clinical or science degree as specified above.