Senior Medical Director, Clinical Development, Solid Tumor

Company: 0750 Stemline Therapeutics Inc

Contract Type:

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: (Senior) Medical Director, Clinical Development, Solid Tumors

Reports to: Vice President, Clinical Development, Solid Tumor s

The Medical Director, Clinical Development Solid Tumor will be responsible for driving the global clinical development strategy in solid tumors. The incumbent will be responsible for providing critical input into the development, management, and implementation of Phase 1-4 clinical studies by closely working with the Clin Ops colleagues; leading multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions. This includes responsibility for the design and execution of first-in-human through registration-enabling studies.

Responsibilities:

• Represent the clinical science line function on global program team(s) and contribute to strategic planning and execution of clinical development plan for the assigned assets being developed in solid tumors.
• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials and other clinical study related documents based on the global development plan.
• Perform medical monitoring (safety data review and identify potential signals), responses to site inquiries, and work with CRO medical monitors when appropriate.
• Take medical responsibility in data analysis and interpretation, reporting and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Report, health authority briefing books, and NDA/BLA submission documents, etc.
• Contribute to operational aspects of study conduct and patient enrolment efforts including participation in site training, initiation and activation and subsequent site engagement activities.
• Maintain focus on robust study conduct and quality data generation.
• Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Responsible for phase I – III clinical development of products.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.

Qualifications:

• Medical Degree with 5+ years pharma/biotech experience. Board certified oncologist and/or training in oncology is strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I-III) leading to successful regulatory submission(s) is required.
• Training in Breast Cancer and/or experience developing Breast Cancer compounds within the industry is required.
• Recognized expert in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyses, and author clinical trial publications.
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent and effective written and verbal communication skills with all levels of the organization.
• Ability to work cross-functionally, partners with oncology development functions such as: Regulatory, Medical Affairs, Statistics, PK/PD and others such as commercial and/or HEOR or other functions as required,
• Experience communicating and interacting with investigations, KOLs, regulatory agencies, and advisors.
• Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates/products (required).
• Proven ability to represent the Company’s interest effectively in interactions with partners and regulatory agencies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s)
• Ability to lead a dynamic group in a fast-paced and hands-on environment.
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• Prior leadership experience preferred.
• Comfortable with ambiguity yet be self-motivated and timeline driven.

NOTE: Role is remote based, with expectations for business travel and onsite presence approx. 20%

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 - 350,000. 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 View email address on aiapply.co. 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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