Shanghai Pharma Biotherapeutics USA Inc. (SPHBio; www.sphbio.com) is a wholly owned subsidiary of Shanghai Pharmaceuticals Holding Co. Ltd. (SPH; www.sphchina.com), one of the largest pharmaceutical companies in China. SPH has developed and delivered healthcare solutions and effective medicines to patients in China for the past century. SPH is committed to continuously bringing innovative medicines to patients that alleviate or cure diseases. SPHBio will be bringing SPH biopharmaceutical innovations, including oncology products, to the U.S. and conducting proof-of-concept clinical trials before finding larger global partners. SPHBio will also be building oncology affiliates and partnerships to identify and develop first-in-class oncology drug products.
The Head, Oncology is responsible for developing, implementing, and leading clinical strategy and operations for oncology drug products. This role oversees the execution of clinical strategies for the Company’s oncology products at all stages of development. The Head, Oncology will also advise on the acquisition of novel targets and/or products upon which to establish SPHBio oncology affiliates and partnerships.
Job Location: San Diego, CA
Develop and execute clinical strategy for each oncology drug product
Design oncology clinical studies
Assist in the preparation of regulatory submissions, which include INDs, briefing documents, orphan drug applications, and NDAs/BLAs/MAAs, etc.
Serve as the Medical Monitor for all SPHBio clinical trials
Maintain knowledge of the global competitive landscape, regulatory environment, regulations and guidelines for each oncology product candidate
Assist in the identification and diligence novel targets and/or products upon which to establish SPHBio oncology affiliates and partnerships
Organize and consult appropriate KOLs in support of oncology products
Contribute to the development and maintenance of clinical working practices and procedures
Manage staff and vendors as needed to support clinical development activities
MD or PhD degree from an accredited institution, with advanced training in oncology
10 - 15 years of clinical development experience in the CRO, pharmaceutical, or biotechnology industry
5+ years supervisory/management experience
Experience designing and implementing clinical oncology protocols
Experience managing external resources (e.g., CROs) to conduct oncology trials
Knowledge of competitive oncology research and product landscape
Experience supporting interactions with regulatory agencies and KOLs
Clear understanding of the drug development process
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
Results-oriented with a keen attention to detail
Energy and drive to succeed in a high-paced start-up environment