Executive Director, Clinical Assessment & Evaluation

Menarini Group•New York, NY

84d•$350,000 - $420,000•Remote

About The Position

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.

Requirements

MD is mandatory.
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).

Nice To Haves

A PhD and/or MBA is highly desirable.
Board certification in Oncology or Hematology is a plus.

Responsibilities

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.
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).
Use scientific and market data to determine which oncology indications offer the highest probability of success.
Provide clinical perspective on in-licensing opportunities, from early-stage platforms to late-stage assets.
Develop and maintain Target Product Profiles (TPPs) for potential assets, ensuring they align with unmet medical needs and have a clear path to regulatory approval.
Perform rigorous biological and clinical pressure-testing to every potential in-license opportunity and how it fits into the competitive landscape.
Forecast the 5–10-year oncology landscape to align our assets with future shifts in the standard of care.
Attend major global summits (AACR, ASCO, ESMO, SABCS), to monitor oncology trends and emerging landscape changes.
Maintain a network of world-class oncology Key Opinion Leaders to stress-test clinical hypotheses and development strategies.