Director​/Senior Director, Clinical Scientist, Solid Tumor

Overview

We are seeking a Clinical Scientist (Director/Senior Director), to join our Solid Tumor Clinical Development department. This role contributes/leads to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Sr. Director, Clinical Scientist will participate in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development.

The This role will collaborate closely with Clinical Development Medical Director(s) to provide scientific expertise necessary to design and deliver on clinical studies and/or programs.

Domestic and international travel may be required (approximately 5-10%)

The Clinical Scientist will play a critical role in the planning, execution, and reporting of clinical trials, primarily in oncology.

Key responsibilities include:

• Clinical Data Management & Safety
  :
• Perform clinical/medical data review, analysis, and interpretation of study results, ensuring accurate data reporting.
• Identify study issues by monitoring emerging clinical data related to safety, efficacy, and PK/PD.
• Design and execute clinical data review plans in collaboration with cross-functional teams, including evaluating specific data trends and performing manual coding of adverse events and concomitant medications as needed.
• Ensure processes and procedures are in place for clinical safety monitoring and patient safety.
• Work closely with the Medical Monitor to keep them informed of pertinent study information, including safety and efficacy data.
• Study Document Development & Regulatory Submissions
  :
• Contribute to the authoring of clinical study protocols and Informed Consent Forms (ICFs)/amendments.
• Review and draft a variety of study and regulatory documents such as Briefing Books, Investigator Brochures (IB), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions (e.g., IND, annual reports).
• Maintain appropriate clinical documentation and submit clinical documents to the Trial Master File (TMF).
• Ensure prompt, quality responses to IRBs/ERCs, IDMCs, etc.
• Collaboration & Communication
  :
• Collaborate and liaise with external partners (e.g., Key Opinion Leaders/KOLs) in various settings (1:1 meetings, investigator meetings).
• In conjunction with the Medical Director, establish and oversee the management of study committees (e.g., Steering Committee, IDMC).
• Serve as the Clinical Science Representative on assigned cross-functional teams.
• Provide regular and timely updates to management regarding study activities and data status.
• Anticipate study-related activities or barriers and present potential resolutions to leadership.
• Training & Presentations
  :
• Develop and present site and CRA training materials at Site Initiation Visits (SIVs) and Investigator Meetings.
• Develop presentations and communicate study data results internally and externally to investigators and at scientific conferences/symposia (abstracts, posters, publications).
• Conduct literature reviews to interpret study data, inform next steps, and maintain current knowledge of the external scientific environment.
• Trial Operations Support
  :
• Ensure Case Report Form (CRF) design adequately supports data collection in alignment with the protocol, collaborating with Data Management/Programming and potentially participating in User Acceptance Testing (UAT).
• May lead or support trial-level activities for one or more trials with necessary supervision.

• 5+ years’ experience in drug development as a clinical scientist or related role in pharmaceutical/biotech industry.
• Advanced degree (e.g. MS, PharmD., PhD) or equivalent experience is required
• Experience in late phase solid tumor oncology is required.
• Proficient with Microsoft Word/Excel/PowerPoint, EDC systems (e.g. Medidata RAVE), and data review tools (e.g., patient profiles, report generating tools)
• Knowledge of GCP, ICH Guidelines and current US FDA regulations.
• Willingness to work Eastern Time Zone (US) hours.

Please note:

this position is classified as a corporate office position. In…