Medical Director, Clinical Development Hematology

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Join us in shaping the future of Menarini - with passion, integrity, and a deep commitment to people.

About Menarini Group - Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. For more than 135 years, we have worked to improve patients’ lives across a broad range of therapeutic areas through our dedication to science, integrity, and care for people. With a strong foundation in scientific excellence and a purpose-driven culture, Menarini offers diverse career opportunities for professionals eager to make a meaningful impact on global health.

Position Title:  Medical Director, Clinical Development, Hematology

Reports To: Vice President, Global Clinical Sciences, Hematology

Overview:

The Medical Director, Clinical Development, Hematology will lead the clinical direction, planning, execution, and interpretation of clinical trials of one or more Heme-oncology clinical development programs, in close collaboration with the Alliance partner. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. The (Senior) Clinical Development Director will be focused primarily on Clinical development of the Menarini-Stemline Hematology Portfolio.

Responsibilities: 

• Participates or leads and demonstrates ownership of the design and implementation of multiple clinical development protocols within the hematology clinical program of an asset in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Menarini-Stemline’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and Menarini-Stemline study staff.
• Has the overall responsibility for monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.
• Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols for which they are responsible.
• Responsible, in collaboration with the clinical scientist, for analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• May oversee the work of Medical and/or Scientific Directors and or Clinical Scientists working on the same or related programs.
• May serve on or lead Clinical Strategy Teams, with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• In the role of CST Lead, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development teams.
• May serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific, clinical and medical activities with internal stakeholders as they relate to ongoing projects.
• May participate in or lead clinical development contributions to due diligence or other business development activity.
• As required by program needs, contributes to partnership with Discovery colleagues to design and implementation of clinical translational strategies.
• May acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Oncology Development, Regulatory, Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Oncology Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Menarini-Stemline at key external meetings.
• Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements. May serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications:

• Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment.
• Completion of a residency program strongly preferred. Completion of a subspecialty fellowship (in heme-onc) is desirable 
• Minimum of 3 years of Oncology industry experience; 3+ years Oncology experience in Biotech/Pharma industry preferred
• Clinical trial experience with relevant classes of agents in the pharmaceutical industry, academia, or equivalent
• Ability to run a complex clinical research program independently.
• Ability to support a global scientific and business strategy
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills, including presentation skills
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Proven ability in establishing and maintaining cross-functional relationships with a wide range of internal and external stakeholders
• Critical thinking skills with unique problem-solving abilities for new and novel obstacles
• Excellent strategic planning abilities
• Willingness to travel
• Strong analytical skills, especially regarding understanding and interpreting scientific and clinical research and literature, are essential

Please note: This position is classified as a corporate office position. In accordance with the New York state 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 $280,000-340,000.  Menarini Stemline offers generous compensation and benefits packages, including, Fidelity 401(k) (with company match), 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.  To request an accommodation, please contact hrus@menarinistemline. com prior to your interview.

Base Salary Range of:

Menarini Stemline offers generous compensation and benefits packages, including Fidelity 401(k) (with company match), Healthcare insurance, 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.

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. 

Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB’s CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.

Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient’s therapeutic journey. 

In 2022, the company launched the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management. 

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.

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