Executive Director, Clinical Assessment & Evaluation

Executive Director, Clinical Assessment & Evaluation

The Executive Director, Clinical Assessment & Evaluation is a physician responsible for supporting business development opportunities at pre-clinical and clinical stages, tasked with translating pre-clinical and early clinical oncology data into prospective, high-value clinical development plans. A key responsibility will be evaluating emerging modalities to determine their potential for clinical success and regulatory approval. Our mission is to build a portfolio of first-in-class assets that redefine the standard of care.

Responsibilities

• Clinical Development Architecture
  • Comprehensive Clinical Foundation: Possess a deep-seated understanding of the current and emerging oncology landscape across the full spectrum of solid tumor malignancies (including GI, Thoracic, GU, etc.)
  • End-to-End Strategic Design: Lead the design of comprehensive Clinical Development Plans that bridge the gap from preclinical "Proof of Concept" to registrational success, ensuring every trial phase is optimized for speed and statistical significance.
  • Novel Design Conceptualization: Draft high-level innovative trial designs (e.g., umbrella, basket, or adaptive trials) for first-in-class assets to efficiently evaluate novel mechanisms of action (MoA).
  • Indication Prioritization: Use scientific and market data to determine which oncology indications offer the highest probability of success.
• Due Diligence & Asset Evaluation
  • Clinical Evaluation: Provide clinical perspective on in-licensing opportunities, from early-stage platforms to late-stage assets.
  • Target Product Profiles (TPP): Develop and maintain TPPs for potential assets, ensuring they align with unmet medical needs and have a clear path to regulatory approval.
  • MoA Gatekeeping: Perform rigorous biological and clinical pressure-testing to every potential in-license opportunity and how it fits into the competitive landscape.
• Competitive Intelligence
  • Anticipatory Analysis: Forecast the 5–10-year oncology landscape to align our assets with future shifts in the standard of care.
  • Conference Representation: Attend major global summits (AACR, ASCO, ESMO, SABCS), to monitor oncology trends and emerging landscape changes.
  • KOL Network: Maintain a network of world-class oncology Key Opinion Leaders to stress-test clinical hypotheses and development strategies.

Qualifications

• Education: MD is mandatory.
• Additionally, a PhD and/or MBA is highly desirable.
• Board certification in Oncology or Hematology is a plus.
• Experience: 12+ years of progressive experience in Clinical Development within biotech or pharma.
• Possess and maintain a deep knowledge of the oncology landscape across solid tumors and a demonstrated ability to predict which scientific trends will yield clinical success.
• Ability to interpret complex biomarker data, PK/PD modeling, and high-level biostatistical outputs.
• A deep professional network within the oncology scientific community.
• Proven experience in scientific due diligence for M&A or licensing deals. Confidence to act decisively and make strategic decisions.
• Deep familiarity with FDA/EMA oncology guidance, including expedited pathways (Breakthrough Therapy, Fast Track, RMAT).

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 $350,000 - $425,000 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.

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.