Job Details

Overview

The Senior Director, Clinical Scientist, provides scientific expertise necessary to design and deliver clinical studies. This role will provide clinical expertise and leadership in support of new product development and marketed products for the team.

We are seeking a Senior Director, Clinical Scientist, 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 Sr. Director, Clinical Scientist will supervise direct reports including Associate Director/Director Clinical Scientist(s). Reporting to the Senior Medical Director, Clinical Development, 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%)

Responsibilities

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.

Qualifications

• 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.

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

Base Salary Range of $245k-$295k (plus (incentive compensation) package). Menarini Stemline offers generous compensation and benefits packages, including 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 and pre-tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Company Overview:

The Menarini Group is an established Italian pharmaceutical company with a nearly 139-year history, founded in 1886 in Naples and headquartered in Florence. We operate globally based on five core pillars: high-quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation, strong people-centricity, and environmental sustainability.

Global Reach & Operations

• Presence: We are present in 70 countries and our products are sold in over 140 locations around the world.
• Workforce: Our global operations are supported by approximately 18,000 employees.
• Manufacturing Power: We are a major producer, manufacturing over 500 million packs of drugs annually across 18 manufacturing sites distributed across six continents.

Strategic Focus on Oncology

Menarini has made a significant global commitment to oncology, notably marking our entry into the US market with the acquisition of Stemline Therapeutics in June 2020. Our vision is to unify innovative therapeutics with advanced diagnostics for faster, more effective, and precise patient management.

• Therapeutics: We have a robust pipeline focused on first in class and first to market investigational compounds for hematological and solid tumors with a specific focus on women's health including breast and gynecologic cancers. Key assets include:
• Tagraxofusp: A novel, first-in-class targeted therapy and the only approved treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in the U.S. and E.U.
• Selinexor: A first-in-class oral Selective Inhibitor of Nuclear Export compound for hematologic cancers and solid tumors, commercialized through an exclusive licensing agreement for Europe and other key territories.
• Elacestrant: An oral SERD for hormone receptor-positive advanced breast cancer, fully developed and successfully launched in the US and EU following a global license agreement.
• Other novel therapeutics under development include MEN2312, an oral KAT6 inhibitor as well as MEN2501.
• Diagnostics: We invest heavily in the liquid biopsy diagnostic field through our affiliate, Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostics solutions.
• MSB offers the CELLSEARCH® Circulating Tumor Cell (CTC) Test, the first and only FDA-cleared blood test for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.
• In 2022, we launched the first-of-its-kind CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, providing a minimally invasive approach to assess plasma cell burden.

This is an exciting and transformative time for the organization. Joining Menarini Stemline offers a significant opportunity to contribute directly to shaping the future of our expanding global Oncology business.

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