Director/ Sr Director/ Ex. Director-Clinical Research- Oncology

Coastal Search Associates, LLC

  • Greenwich Area, CT

  • Posted Published: January 31, 2017
Job Type
Category
Key SKill
MD required--Minimum of 10 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) • Board certification/eligibility
No of Openings
one
experience
10-15
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Job Description

My client is an Early Stage Connecticut Pharmaceutical company.

 Director/ Sr Director/ Ex. Director-Clinical Research- Oncology  

Overview:

You will be responsible for the clinical development strategy for both early stage research compounds as well as clinical stage compounds, align with the broader strategy of
the multifunctional project teams, and coordinate and monitor the clinical studies to be carried out in support of the development plan for these compounds.

Responsibilities include but are not limited to:
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

Job Qualifications:

  • MD required--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

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