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Senior 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. For more information, please visit www.cullgen.com.
Position Summary
The Senior Medical Director will be responsible for the worldwide development, execution and management of Cullgen’s clinical programs across numerous therapeutic areas and phases of development. We are looking for a highly organized individual with experience in both clinical trial and management roles. The Medical Director will work closely with other functional areas within Cullgen including R&D, pre-clinical development, CMC, regulatory, finance, and corporate development. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed rapidly growing clinical stage biotechnology company established on an 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 clinical trials in pain, inflammatory disease, oncology and other disease areas.
Prepare clinical documents necessary for trial conduct and manage regulatory strategies and interactions with FDA.
Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
Provide leadership responsibilities for the company’s wholly owned subsidiary, Cullgen Australia, by acting as General Manager of Cullgen Australia.
Recruit, lead and mentor clinical development team.
Qualifications:
MD with Board Certification in anesthesiology, rheumatology or oncology. Anesthesiologists with experience in the development of pain medicine are preferred.
Multiple years of experience in clinical practice treating patients and biopharma industry experience working on investigational new drugs.
Multiple years of experience in clinical development including managing clinical & medical affairs teams.
Knowledge of relevant FDA/ICH regulations and guidelines. Experience in interactions with FDA personnel is critical.
Possess a thorough knowledge and experience in science- and data-driven drug development.
A proven success record in clinical trial design and IND submissions.
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; an effective team player who can invoke confidence and credibility within and outside the company.
About Cullgen Inc.:
Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies designed to improve the lives of patients suffering from critical and in some cases life-threatening conditions such as pain, cancer and inflammation. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its founders’ expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved efficacy and avoidance of known toxicities. Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (“TRK”) degrader that is currently being studied in a Phase 1 trial for the treatment of acute post-operative pain and in a Phase 1 trial for the treatment of solid tumors. Both trials are currently enrolling patients. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being developed for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia (“AML”), higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs, including certain partnered programs, targeting indications within oncology and inflammatory diseases.
Cullgen offers a competitive benefits package including medical, dental, vision, life and disability insurance benefits for employees and their families. We also offer a 401(k) plan with a matching contribution, generous paid time off and more.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected category.
Cullgen is an EEO Employer.