Menarini Stemline · 1 day ago
Senior Director, Clinical Scientist, Solid Tumor
United States
Full-time
Remote
Director/Executive
$245K/yr - $300K/yr
8+ years expMenarini Stemline is an established Italian pharmaceutical company with a strong focus on oncology. The Senior Director, Clinical Scientist, will provide scientific expertise for clinical studies, contributing to the development and execution of clinical trials primarily in oncology, while ensuring scientific integrity and data interpretation.
BiotechnologyHealth CareHealth DiagnosticsOncology
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
Qualification
Required
8+ 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
Benefits
Short- and Long-Term Incentive Programs
Fidelity 401(k) (with company match)
Anthem Premier PPO and HDHP insurance plans
Company paid Basic Life & AD&D insurance
Pre-tax FSA/HSA programs
Company
Menarini Stemline
The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc.
501-1000 employees
H1B Sponsorship
Menarini Stemline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (2)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$195.09MKey Investors
Pequot Capital
2020-05-04Acquired
2019-08-01Post Ipo Equity· $88M
2019-01-15Post Ipo Equity· $92M
Leadership Team
David Gionco
Vice President of Finance and Chief Accounting Officer
Ahmed Rabie
Chief Commercial Officer
Recent News
2025-10-13
2025-09-27
Company data provided by crunchbase