Associate Director/Director, Clinical Contracts & Outsourcing (13-130) FibroGen
The Associate Director/Director, Clinical Contracts will play an integral role in the execution of the Company?s clinical studies
The successful incumbent will be primarily responsible for vendor contracts in the Fibrosis and China Anemia programs. However, this role could expand to take on site contracts and/or direct reports.
FibroGen is advancing its clinical pipeline and is launching several Phase 3 trials in the near term. Key to the Company?s ability to do this will be proper vetting of vendors, negotiating of best possible prices, and continuing oversight of the process to ensure compliance within a SOX and GCP/GLP environment.
Specific responsibilities will include:
Partner with Legal and finance to write, review, amend, negotiate and close contracts
Ensure contracts are fair, equitable and enforceable
Keep accurate records, meet report deadlines and document significant events
Build and develop strong relationships with vendors
Prepare RFP, RFI and contract templates
Develop and maintain vendor selection documentation and processes
Review contract obligations in conjunction with Project management and Clinical Operations staff
Notify vendors/partners/subcontractors formally where issues/special circumstances or breaches of contract have taken place
Assist and work with senior management on special projects
Monitor vendor progress and performance to ensure goods and services conform to the contract requirements
Authorize payments consistent with the contract terms
Resolve disputes in a timely manner
Prepare and conduct project kick-off meetings, including delivering detailed briefing to the project and accounting teams
Minimum of a BS plus 7+ years? clinical contracts experience, including U.S. and global trial experience. Experience in clinical finance or clinical operations would also be considered.
Expertise in large, multi-site, later stage clinical trials is required.
The ideal candidate will have experience working departments that have established processes in place.
Direct experience vetting and negotiating with vendors is a must.
Deep understanding the clinical process, including budgeting, is important.
Demonstrated capability of managing multiple external vendors for multiple clinical trials simultaneously.
Demonstrated leadership qualities, and strong influencing skills.
Management experience would be a plus.
Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP.
Demonstrated ability to multi-task, prioritize, and independently solve problems in a rapidly changing environment.
A strategic thinker who can efficiently utilize company resources and expertise to extract optimal vendor performance.
A strong person with the interpersonal skills and credibility, both internally and externally, to successfully negotiate contracts beneficial to the Company.
An excellent communicator, both written and verbal, with the ability to train and present data, complex protocol designs etc., and influence internal and external colleagues as required.
Excellent organizational skills and attention to detail.
An innovative, driven and effective person with a ?can do? attitude.
A goal-oriented person who can plan for the long-term and execute stated objectives.
A flexible individual who can operate comfortably in a rapidly changing and sometimes ambiguous environment.
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