Head, Oncology

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.

Responsibilities:

  • 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

Required Background:

  • 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