(Senior) Medical Director, Clinical Development, Solid Tumors

Overview 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 plus annual bonus & long-term Incentives. 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. 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. #LI-MB1

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.