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Medical Director - Oklahoma City, United States - Pharma People
Description
Our clinical-stage biopharmaceutical client is seeking aMedical Director / Senior Medical Director
with strong Oncology Clinical Development experience to cover development programs spanning phases I,II,III.
Responsibilities:
clinical leadership; from early-stage clinical trial design for novel cancer drugs through to CoP stage
closely and liaise with the clinical operations team, clinical study teams, pharmacovigilance, the SVP and stakeholders
in protocol design through all phases
highest ethical standards are met in terms of compliance, laws and
Support regulatory leaders with submissions and strategy development.
Prepare clinical reports and publications
Presentations at regulatory meetings, internal and external meetings
As well as the above teams, maintain and develop relationships with partners, sponsors, CROs, KOLs, and patient advocacy groups
Requirements & Qualifications
An M.D. or M.D/Ph.
D. with 3+ years experience as a Medical Director in Oncology Clinical Development
Significant drug development experience from IND through NDA
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in strategy development and protocol design
Experience designing, planning, and monitoring clinical trials.
Experience presenting to internal and external audiences
Ability to work well with others and build up members of a cross- functional team in a fast-paced environment
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