OverviewThe 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.
ResponsibilitiesClinical 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.
QualificationsEducation:
- 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).
NOTE: Role is remote based, with expectations for business travel and onsite presence approx. 15%
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-$420,000 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.
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