Genesis Therapeutics is a pioneering AI Biotech company focusing on the discovery of novel drugs using unique approaches to both undrugged and underdeveloped targets with the goal of providing new treatments for patients with severe diseases.

Genesis has raised over $280M in funding from top technology and biotech investors, including Andreessen Horowitz, Rock Springs Capital, T. Rowe Price, Fidelity, Radical Ventures, NVentures (NVIDIA's VC arm), BlackRock, and Menlo Ventures. In addition, Genesis has announced two AI platform collaborations across a range of therapeutic areas with Genentech and h Eli Lilly, the latter of which entailed a $20M upfront payment with a $670M total deal size. We’ve also been featured in Forbes 30u30 and in Forbes AI 50.

Genesis originated in graph machine learning research in Vijay Pande’s lab at Stanford, when it was joined by legendary drug hunters and biotech entrepreneurs (including Dr. Leonard Bell, founder and CEO of Alexion Pharmaceuticals, acquired by Astra Zeneca for $39Bn; and Peppi Prasit, storied chemist from Merck known for Vioxx, Arcoxia, Singulair, who then went on to found Amira Pharmaceuticals, acquired by BMS, and Inception Sciences). The company is making strong progress in expanding the domain of our AI technology with the advance of our pipeline of best-in-class and first-in-class programs, both internal targets and those in partnership with Genentech and Lilly.

Desired Candidate Profile

We seek a scientific leader with extensive experience in Translational Research and Clinical Biomarkers to develop and deliver biomarker strategy and patient selection (Companion Diagnostic) for preclinical programs entering early development. The role will contribute at a broad and strategic level by developing, implementing, and executing early phase clinical studies applying a translational approach. Level and compensation will be commensurate with experience.

Responsibilities

Develop, establish, and lead efforts aimed at 1) Pharmacodynamics, 2) Patient stratification and selection based on Companion diagnostic biomarkers and 3) Disease relevant biomarkers with association to clinical endpoints.
Lead drafting of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
Collaborate with Research team to select and implement fit-for-purpose assays based on scientific questions and regulatory requirements.
Undertake cross-functional engagement with Clinical leads, and Clinical Operations for implementation of biomarker analyses and diagnostic assays in the clinic.
Manage relationships with external consultants and analytical labs, provide input into trial-specific agreements and perform technical assessment of labs involved in biomarker sample analysis.
Ensure biomarker sample collections, analyses, data transfers, and reporting are performed in accordance with study protocols and in compliance with regulatory requirements.
Accountable for the cost efficiency and timely delivery of biomarker data and quality commitments including ICH/GCP and applicable regulations.
Responsible for developing and executing biomarker and Companion Diagnostics operations plan for clinical studies including scenario planning, assessment of feasibility, forecasting of timelines and resource requirements.

Qualifications

Experience and ideally proven record in leading and/or supporting translational strategy of Oncology and non-Oncology programs in clinical development in pharmaceutical and/or biotech environments.
PhD, PharmD, and/or MD with 10+ years of related work experience in pharmaceutical and/or biotech environment
Preference for candidates who have experience with bioanalysis and fit-for-purpose assay requirements
Preference for candidates who have experience with developing companion diagnostics strategy
Experience implementing clinical biomarkers in early phase clinical studies
Interdisciplinary knowledge of broad biomarker approaches and enabling technologies including fluid, imaging and digital biomarkers and liquid biopsy
Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals
Ability to work in matrix-based program teams
Experiences in development of clinical study documents, such as investigator brochures, clinical protocols, procedure manuals and/or regulatory documents