Direct and coordinate all outsourcing and contracts needs in support of Project
Teams, Clinical Sub-Teams and Functional Groups, including Service Provider
(SP) identification, selection, and oversight, SP and clinical site contract
development, and issue management. Work closely with Clinical, Finance &
Legal. Reporting into Chief Medical Officer.
- Service Provider 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 SPs and clinical institutions
- Coordinate internal budget and contract approval processes
- Provides support to functional groups (Clinical and Finance) for short and
long-term budgeting and financial reporting
- Collect performance metrics and provide analysis for assessment and management
of SPs
- Develop Sponsor-Service Provider relationships and manage performance feedback
- Support ongoing oversight of SPs
- Maintain knowledge on SP capabilities and industry trends
- Identify needs and implement standard procedures and business practices
on outsourcing processes and effective SP management
- Implement training on procedures and practices
- BS/BA in Life Science, finance or related discipline, or equivalent education.
- Minimum 10 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.
- Successful track record of building and developing an Outsourcing &
Contracts group.
- Understanding of Legal and Regulatory issues associated with Clinical Research.
Direct experience with clinical outsourcing is required.
- Strong financial skills and ability to handle a variety of budgets
- 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
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
