Location: South San Francisco, CA
The Associate Director / Director, Clinical Contracts will collaborate with clinical trial teams and other internal stakeholders, vendors and investigational sites to support timely study start-up to meet organizational goals. Responsible for managing vendor selection, site contracting and the negotiation and execution of other required agreements to support the clinical development plan. Project manage and coordinate all contracting needs in support of Project Teams and Clinical Sub-Teams, including Service Provider (SP) identification, selection and oversight, clinical site contract development, and issue management. This role reports into the Chief Legal and Administrative Officer & Corporate Secretary.
- Service Provider (SP) identification, qualification and selection
- RFP and bid grid generation
- Proposal coordination and analysis
- Coordinate bid defense meetings and feedback
- Perform SP assessment visits and report findings
- Negotiate and manage contracts, budgets and change orders, as primary business contact for service groups, CROs and clinical institutions
- Provides support to functional groups (Clinical and Finance) for short and long-term budgeting and financial reporting
- PO generation and management of clinical contracts
- Ongoing contract management (change orders, amendments)
- Collect performance metrics and provide analysis for assessment and management of SPs
- Develop Sponsor-Service Provider relationships
- Implement training on procedures and practices,
- BS/BA in Life Science, business or related discipline, or equivalent education.
- Minimum 7-8 years industry experience in drug development and/or commercialization, or equivalent experience.
- Minimum 5 years experience in service provider/client management, business operations or contract management, with proven negotiation skills.
- Understanding of Legal and Regulatory issues associated with Clinical Research. Direct experience with clinical contracts is required.
- Experience with or knowledge of various types of industry service providers; proven knowledge of drug development process (Phase I-IV).
- Ability to think and plan strategically.
- Strong planning and organizational skills and an ability to handle multiple priorities
- High degree of customer focus for both internal and external customers and proven ability to build and maintain effective internal and external partnerships. Ability to facilitate conflict resolution.
- Strong analytical and problem solving skills.
- Proven project management skills, excellent communication skills, both verbal and written.
- Fully proficient in Microsoft Word and Excel.
- Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
- Ability to successfully function in a fast-paced environment
Cortexyme is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, disability status or any other characteristic protected by law.
For more information on Cortexyme, visit www.cortexyme.com.