Executive Director, Clinical Assessment & Evaluation

Menarini Group; New York (NY); On-site; USD 250,000 - 350,000; Full time

Job summary

Menarini Group in New York seeks an Executive Director, Clinical Assessment & Evaluation to lead the clinical development architecture for oncology assets. The role translates preclinical and early clinical data into high-value development plans and regulatory strategies for fast, value-driven progress.

The candidate will drive due diligence, TPPS, MoA evaluation, and competitive intelligence, while building and leveraging a global KOL network and representing the company at major conferences to

Qualifications

• MD degree is mandatory.
• PhD and/or MBA highly desirable.
• Board certification in Oncology or Hematology is a plus.

Responsibilities

• Develop and lead end-to-end Clinical Development Plans bridging preclinical to registrational trials.
• Evaluate in-license opportunities and maintain Target Product Profiles (TPP) in line with unmet medical needs and regulatory pathways.
• Forecast oncology landscape to align assets with future standards of care and engage KOLs; represent the company at major oncology conferences.

Skills

Clinical development planning

KOL network management

Strategic oncology assessment

Education

MD

PhD

MBA

Board certification in Oncology or Hematology

Job description

Overview

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.