Director/Senior Director, Clinical Scientist, Solid Tumor

Menarini Group•, NY

22d•$215,000 - $275,000•Remote

About The Position

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%).

Requirements

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.

Responsibilities

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.
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.
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.
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.
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.