Scientific Director responsibilities include, but are not limited to, the following
Scientific Director in St. Charles, MO.
- Develop client scientific and regulatory relationships (existing and new)
- Provide guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner
- Defines scope of work, focus of the project and consultation to the client
- Defines the appropriate technical approach to accomplish the clients requirements
- Provide Program Managers with scope of the work, estimates of time required to complete the project, level of technical challenges for expectation setting and scientific input for use in proposal preparation.
- Present proposal to clients for new clients and new services and address any concerns from the client
- Propose the expertise needed for the Study Directors, Principal Investigators (GLP) or Scientific Director (GCP and GMP) and Lead Scientists (for assay development studies) for each client study based on the client requirements and experience with the client
- Serve as Study Director, Principal Investigator or Scientific Director or Lead Scientist as needed
- Accountable for sign off of validation plans and reports as provided by the validation team.
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Conducts all activities in a safe and efficient manner
- Owns the accountability and responsibility of delivering to client needs and timeliness
- Provides cross-functional support to other departments as required
- Adheres to site environmental health and safety (EHS) requirements
The ideal candidate would possess:
- Excellent interpersonal, verbal and written skills, including ability to prepare detailed scientific reports and group presentations
- A working understanding of international regulatory requirements including MHRA and FDA GMP, GCP and GLP and a proven mechanism to stay relevant on such requirements
- Demonstrated ability to work independently and without instruction
- Appropriate technical expertise in relevant laboratory techniques
Basic Minimum Qualifications:
- A PhD or Masters degree in a biological science, or equivalent experience.
- At least 5 years relevant experience in pharmaceutical industry and/or CRO or similar
- Demonstrated success in client interaction, proposal development and sound project plans, presentation to clients at VP and higher levels and develop client relationships
- Demonstrated experience in working effectively with business development, sales and customer service organizations
- Experience in managing and leading cross functional teams effectively