Medical Director Clinical Development
Company: Association of Clinicians for the Underserved
Location: Irvine
Posted on: April 10, 2021
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Job Description:
Clinical stage biopharmaceutical company seeks a Medical
Director to lead all functions of clinical development within the
company. The Medical Director is responsible for the content,
conduct of the clinical development program and clinical trials in
this program. Our client has a drug that received FDA approval in
Dec 2020 and another gene therapy product in phase 1 trials. All
candidates for this role must be M.D.s.Requirements for Medical
Director - Clinical Development:MD required10+ years of experience
in clinical development or associated activities.Proof of concept
and Phase 3 drug development experience Strong leadership skills
with a commitment to collaborative leadership, and the ability to
work cross functionally at all levels within an organization.
Urology or gene therapy experience preferred Strong organizational
skills, and a track record of accomplishment managing multiple
competing projectsExceptional communications skills; oral, written,
presentation and electronicThe ability to work in different time
zones, including international Thorough understanding of ICH Good
Clinical Practices, clinical safety data management, clinical
trials management (including protocol design, data management, site
monitoring, statistical reporting, report writing), regulatory
compliance and auditing including broad application of knowledge in
different therapeutic areas.Responsibilities of the Medical
Director - Clinical DevelopmentLead the cross functional clinical
development team including vendors, contract research organizations
and consultants, Lead medical input for associated programs.Develop
the clinical development program and trial protocol in
collaboration with vendors and consultants and clinical sections of
investigator brochures, clinical study reports, presentations,
briefing documents and submissions in collaboration with all
functions, vendors and consultants.Provide input on business
development activities and due diligence.Prepare clinical
development program budgets, maintaining timelines with project
manager. Provide guidance in internal process improvement
activities as SOPs or guidance documentsType: direct hire
1420 Spring Hill Road
Suite 600
McLean, VA 22102
Keywords: Association of Clinicians for the Underserved, Irvine , Medical Director Clinical Development, Executive , Irvine, California
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