Director, Clinical Scientist, Hematology

We are seeking a Director to join our Hematological Malignancies Clinical Development department. This role provides scientific expertise necessary to design and deliver clinical studies, offering clinical leadership in support of new product development and marketed products.

About the role

The Director, Clinical Scientist will contribute to the development, evaluation, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data within a clinical development program. This position may participate in and/or lead cross-functional teams in a matrix environment, contributing to candidate development projects through early and/or late phase development. The Director reports to the VP, Global Clinical Sciences and collaborates closely with Medical Directors in Clinical Development.

Domestic and international travel may be required (approximately 10-20%).

Responsibilities

• Function as lead Clinical Scientist for assigned protocol(s) or delegate of Therapeutic Area Lead Clinical Scientist.
• Contribute to or lead protocol/program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in collaborative activities with other departments as a member of the Clinical Study Team.
• Design and execute assigned clinical studies/activities, working closely with clinical team members to ensure study conduct.
• Develop studies in accordance with current Stemline Menarini policies and procedures.
• Propose, design, and execute clinical research and development studies for early and/or late-stage assets, grounded in supporting literature.
• Contribute to or lead planning and preparation for external/stakeholder meetings (e.g., Investigator Meetings, Governance, Data Monitoring Committees, Regulatory Authority interactions).
• Present data and information to external investigators (Site Initiation Visits) and internal stakeholders.
• Perform clinical/medical data review, including clinical safety monitoring and activities ensuring patient safety.
• Apply analytical knowledge to understand how program objectives and design impact data analysis; identify risks and design mitigation strategies.
• Promote consistent first-line medical/clinical data review techniques and conventions across studies/programs.
• Review clinical data review plans and author medical monitoring plans for assigned studies/programs.
• Collaborate cross-functionally to develop Synopsis/Protocol and Informed Consent Form (ICF) documents/amendments; present these to governance committees and early clinical development team meetings.
• Ensure prompt, quality communications with sites regarding protocol clarification and procedural queries.
• Author/review clinical contributions to Clinical Study Reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, Health Authority, Ethics Committee, IRB responses, and contribute to regulatory submissions).
• Lead or support trial-level activities for one or more trials with necessary supervision.
• Collaborate and liaise with external partners (e.g., Key Opinion Leaders).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Conduct literature reviews.
• Prepare and present data externally in the form of abstracts, posters, presentations for symposia, conferences, and external journal publications.
• Develop site and Clinical Research Associate (CRA) training materials and present these at Site Initiation Visits (SIVs) and Investigator meetings.
• Review clinical narratives.
• Collaborate cross-functionally to monitor clinical data for specific trends.
• Contribute to the development of Data Review Plans in collaboration with Data Management.
• Ensure Case Report Form (CRF) design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming; may participate in User Acceptance Testing (UAT).
• Submit clinical documents to Trial Master File (TMF).
• Ensure prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.

Requirements

• Basic Life Science degree or equivalent and 10 years of industry or relevant experience, with 5+ years as a clinical scientist.
• Advanced degree (e.g., MS, PhD, PharmD) or equivalent experience preferred.
• Hematology oncology experience required.
• Basic to intermediate knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines evolution.
• Intermediate problem-solving and critical thinking skills.
• Understanding of the pharmaceutical industry and the clinical development process.
• Clinical training and/or applicable clinical research experience; understanding of running clinical trials from concept to publication.
• Adaptable/flexible, able to adjust to multiple demands and shifting priorities while meeting day-to-day challenges with confidence and professionalism.
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report-generating tools).
• Knowledge of worldwide regulatory and safety requirements as they pertain to drug development, research projects, and/or market support.
• Strong interpersonal relationship-building and maintenance skills.

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

Benefits

• 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.

Pay

Base Salary Range of $218,000-$255,000.

About the Company

Founded in 1886 in Naples, Menarini is an Italian pharmaceutical company with nearly 135 years of history, headquartered in Florence. The Menarini Group operates in 70 countries, with products sold in 140 locations worldwide. The company employs around 18,000 people and produces over 500 million packs of drugs annually across 18 manufacturing sites, including a biotech plant for monoclonal antibodies.

Menarini has a strong commitment to oncology, with a pipeline of five investigational compounds for hematological and solid tumors. The acquisition of Stemline Therapeutics in 2020 strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Key products include:

• Tagraxofusp: A first-in-class targeted therapy for blastic plasmacytoid dendritic cell neoplasm (BPDCN), the only approved treatment for BPDCN in the U.S. and EU, and the first CD123-targeted therapy. It is also being evaluated for other CD123+ indications such as acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF).
• Selinexor: A first-in-class, oral Selective Inhibitor of Nuclear Export compound for hematologic cancers and solid tumors, licensed from Karyopharm Therapeutics for commercialization in Europe, Latin America, Turkey, Russia, and CIS countries. It is marketed in the U.S. for multiple myeloma and under development for solid tumor indications.
• Elacestrant: An oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer, approved by the FDA in January 2023 and the EMA in September 2023.

This is an exciting opportunity to contribute to building and shaping Menarini Stemline’s Oncology business.