Director/Senior Director, Clinical Scientist, Solid Tumor

We are seeking a Clinical Scientist (Director/Senior Director) to join our Solid Tumor Clinical Development department. This role contributes and leads the development, evaluation, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data within a clinical development program. Domestic and international travel may be required (approximately 5-10%).

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.

Requirements

• 5+ years’ experience in drug development as a clinical scientist or related role in the 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.

This position is classified as a corporate office role. In accordance with the New York employer convenience rule, Menarini Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Pay

Base Salary Range of $215k–$275k plus an incentive compensation package.

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.

About the Company

Founded in 1886 in Naples as Farmacia Internazionale, Menarini moved to Florence in 1915, where the Group’s headquarters remain today. The Menarini Group is an Italian pharmaceutical company with nearly 135 years of history, present in 70 countries, with products sold in 140 locations worldwide. Its companies span Europe, Asia, Africa, the Middle East, Central America, and the United States, where the acquisition of Stemline Therapeutics marked its entry into the US oncology market.

With around 18,000 employees, Menarini produces over 500 million packs of drugs annually across 18 manufacturing sites, including a biotech plant for monoclonal antibodies. The company has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for hematological and solid tumors. The acquisition of Stemline Therapeutics in 2020 further strengthened Menarini’s oncology portfolio, adding commercial and clinical-stage assets.

Menarini Stemline’s portfolio includes Tagraxofusp, a first-in-class targeted therapy for blastic plasmacytoid dendritic cell neoplasm (BPDCN) and the only approved treatment for BPDCN in the U.S. and EU. It is also being evaluated for other CD123+ indications. Additionally, Menarini holds exclusive rights to commercialize Selinexor for oncology in the EU, Latin America, and other regions, as well as Elacestrant, an oral SERD approved for hormone receptor-positive advanced breast cancer.