Medical Director, Hematology

Reports To (Position): Executive Director, Clinical Development

Location: South San Francisco, CA

Department Name: Clinical Development

HR Designations: Pay Status – Exempt

Objective of Position

The Medical Director, Hematology oversees the direction, planning, execution, and interpretation of clinical trials and the data collection activities.

Essential Duties/ Responsibilities

  • Directs protocol implementation including site identification and communication, attendance at investigators’ meetings, correspondence with sites including IRBs and interaction with operations teams
  • Manages program development, including working cross-functionally with all of the disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilence, and clinical operations
  • Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration
  • Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
  • Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts
  • Supports commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team
  • Interacts closely with Medical Affairs in support of ISTs and publications
  • Interacts closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies

Requirements

  • Interacts closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies
  • Demonstrated independence, initiative and the ability to work well in a fast-paced environment
  • Travel time is approximately 15% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings

Education/ Training

  • MD
  • Minimum three years of industry experience
  • Sub-specialty training in oncology and/or hematology preferred
  • Outstanding academic achievement and significant clinical trial experience preferred


Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 

Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.