Senior Medical Director, Clinical Development

Location
San Diego, California
Salary
Competitive / Market value
Posted
Oct 12, 2020
Ref
OM21503
Required Education
Doctorate/PHD/MD
Position Type
Full time

OVERVIEW
This role as the Sr Medical Director, Clinical Development is a fantastic opportunity for those that have a passion for science and thrive to improve and transform the lives of cancer patients within a small biotech company.  You will advance a lead drug candidate as a single agent or in combination into clinical trials across a range of solid tumours.

The Company is looking for an innovative leader who is established within the medical community, that is both rigorous, skilled and capable of complying with relevant guidelines and GCP.
     
RESPONSIBILITIES
•    Lead global oncology clinical trials (Phase I-III) and ensure that clinical studies are carried out in accordance with the Clinical Development Plan (CDP), GCP/ICH and FDA and other relevant requirements
•    Generation and update of CDP
•    Leadership and mentoring of clinical team members
•    Involved in preparation of clinical sections of key regulatory documents, including IND annual reports and briefing packages
•    Prepare presentation materials for meetings (internal and external), including team meetings, Ad Board, and Board of Director Meetings
•    Chair clinical trial meetings to update upper management and clinical staff on patient recruitment, trial issues, investigator feedback, patient enrollment issues and planning for issue resolutions
•    Prepare posters, abstracts and presentations for scientific meetings.
•    Author and review clinical documents for the conduct of clinical studies
•    Act as the initial contact with sites, answering queries about eligibility, enrollment and management of patients
•    Involved in creation of data analysis plans, CRFs, study reference manuals, patient diaries and drug accountability forms

REQUIREMENTS
•    Medical Doctor (MD) - Board Certification in Medical Oncology is preferable
•    At least 5 years’ experience in clinical development in pharma/biotech
     o    At least 2 years involved in oncology drug development.
     o    Phase III oncology clinical trial experience as a medical leader is preferred.
•    Availability to travel
•    History of being able to communicate and interact with investigators, varied functional groups, KOLs and the medical/scientific community. 
•    A successful leader, capable of mentoring and quickly adapting to new goals and needs.