Medical Director
San Diego, CA
Company Overview
Cullgen is a privately held biopharmaceutical company dedicated to the development of first-in-class new chemical entities (NCEs) for the treatment of diseases lacking effective therapeutic approaches through targeted protein degradation technology (TPD, also known as PROTAC). Cullgen is making major efforts in advancing the technology, concentrating on the discovery of novel E3 ligands. The Company’s technology platform, uSMITE™, is designed to treat cancer and immune diseases through ubiquitin-mediated, small molecule-induced target elimination of disease-causing proteins that are previously considered as undruggable.
Embracing the globalization of healthcare R&D, Cullgen has initiated drug discovery and business development efforts in the United States, Japan and China to build a strong, collaborative and efficient international drug discovery platform.
Position Summary
The Medical Director’s primary role will be to provide leadership and direction for the strategy and execution of Cullgen’s clinical development. We are looking for highly organized candidates with extensive experience in both clinical trial and management roles. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed rapid growth stage biotechnology company established on a newly emerging platform with unprecedented opportunity in drug discovery. This position is based in San Diego and reports directly to the CEO and CSO.
Key Responsibilities:
Coordinate the pre-clinical and clinical development of multiple therapeutic degrader programs.
Direct the development of clinical strategies and plans to advance Cullgen’s therapeutic compounds into the clinical trials in oncology, pain and other medical areas.
Prepare clinical documents and manage regulatory strategies and interactions with FDA.
Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
Recruit, lead and mentor clinical management team.
Qualifications:
MD with Board Certification. Hematology, oncology and immune-oncology training preferred.
Multiple years of experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience working on investigational new drugs. • Multiple years of management experience leading a clinical group including clinical & medical affairs.
Knowledge of relevant FDA/ICH regulations and guidelines. Experience in interactions with FDA personnel is critical.
Have a thorough knowledge and experience with drug development and must be science- and data-driven.
A proven success record in clinical trial design and submission of IND.
Read, write, and speak fluent English, possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, company employees, and the investor community.
Excellent leadership and interpersonal skills; Skills as an effective team player who can bring about confidence and credibility within and outside the company
Cullgen is an EEO Employer.