Senior, Expert

Director, Clinical Scientist, Hematology

US · On-site

Overview

The Director Clinical Scientist role 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 Director to join our Hematological Malignancies Clinical Development department. The Director, Clinical Scientist will contribute 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 Director may participate in and/or lead 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. Director reports to the VP, Global Clinical Sciences and collaborates closely with Medical Directors in Clinical Development to provide scientific expertise necessary to design and deliver on clinical studies and/or programs.

As a Clinical Scientist Director, a typical day may include the following:

Functioning as lead Clinical Scientist for assigned protocol(s) and/or may function as delegate of Therapeutic area Lead Clinical Scientist. May contribute or lead protocol/program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments; Member of the Clinical Study Team.

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

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Responsibilities

Responsible for design and execution of assigned clinical study/activities and works closely with clinical team members to execute activities associated with study conduct.
Develop studies in accordance with current Stemline Menarini policies and procedures.
Possesses scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
Contributes/ leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
Performs clinical/medical data review, including clinical safety monitoring and activities and procedures that ensure patient safety
Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
Collaborate cross-functionally to develop Synopsis/Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
Ensures 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, HA, EC, IRB responses and contribute to regulatory submission.)
May lead or support trial level activities for one or more trials with the necessary supervision.
Collaborate and liaise with external partners (e.g., KOLs).
Seek out and enact best practices with instruction.
Provide regular and timely updates to manager/management as requested.
Conduct literature review.
May prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publications
Develop site and CRA training materials and present these at SIVs and Investigator meetings.
Review clinical narratives.
Collaborate cross-functionally to monitor clinical data for specific trends.
Contribute to the development of Data Review Plan in collaboration with Data Management.
Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming and may participate in UAT.
Submit clinical documents to TMF.
Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.

Qualifications

Basic Life Science degree or equivalent and 10 years of industry or relevant experience with 5+ years as clinical scientist
Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience, preferred
Haematology 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 trial from concept study idea to publication
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet 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 pertains to drug development, research projects, and/or market support.
Good interpersonal relationship building/maintenance

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

***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 $218,000-$255,000. Menarini Stemline offers generous compensation and benefits packages including 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.

The Company

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.