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 Senior 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
- Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
- 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
- Minimum 6 years of industry experience
- Sub-specialty training in oncology and/or hematology
- 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.