Medical Director or higher

Cameron Craig Group
Oct 12, 2016
Nov 01, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Medical Director, Oncology (title will be commensurate of experience)
This Medical Director will assist with the clinical development strategy for both early stage research compounds as well as clinical stage compounds, align with the broader strategy of the multifunctional projectteams, and coordinate and monitor the clinical studies to be carried out in support of the development plan for these compounds.
Key Responsibilities:
In conjunction with other relevant functional areas, develop the strategic development plan for this compound
Provide medical and development leadership for cross functional teams
Collaborate and help manage external vendors such as CROs
Oversee the writing of protocols, the conduct of trials and the analyses of data for this compound
Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for these compounds and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems independently
Interact with clinical site PIs and KoLs to manage clinical strategy development and execution
Ensure compliance with Company SOPs, ICH, GCP and other national and international regulatory requirements
Minimum Qualifications:
Minimum of 10 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s)
Board certification/eligibility
Preferred Qualifications:
Ability to work collaboratively in a challenging team matrix environment.
Ability to work independently to resolve challenges and conflicts
Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
Have a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes
Experience in filing and defending US INDs and/or NDAs and international equivalents preferred
Excellent communication skills

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