Manager, Clinical Outsourcing
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
This position will report into the Senior Manager, Clinical Outsourcing (FMV). This position will undertake activities to provide specialized support and assistance to Clinical Operations, Legal/Contracts, Finance Departments, as required, in the administration and negotiation of clinical site study budgets (in regards to Fair Market Value procedures). This will involve building partnerships with the Clinical department's leadership, Procurement, Legal/Contracts, FP&A, and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in an optimal and efficient manner that is consistent with company policy, as well as legal, government, and regulatory requirements where relevant.
Key Accountabilities/Core Job Responsibilities:
- Provides operational expertise and strategic leadership, support, guidance and training to teams on all aspects of clinical outsourcings involvement with the FMV process.
- Work closely with the Clinical Operations, Legal, and Finance teams to support clinical studies' meeting FMV requirements.
- Collaborates cross-functionally to ensure the most optimal outsourcing FMV strategies and solutions are achieved in alignment with DevOps objectives while achieving best value for the company.
- Manage FMV analysis and exception activities either directly or through managing junior staff's efforts.
- Develop and maintain a system for tracking progress and status of FMV related concerns.
- Works with Site Budget team to develop best practices for ensuring FMV compliance.
- Coordinate communication between and serve as a liaison between internal and external stakeholders with regard to FMV requirements.
- Proactively identifies potential areas of FMV compliance risk and recommends/implements solutions.
- Participates in the development, review and implementation of departmental SOPs, tools, and processes.
- Supports the Clinical Outsourcing Site Budget team with data collection, analysis, and projects as assigned.
- Assist with the tracking of FMV metrics.
- 4 Year college degree with BS/BA in Life Science, Finance, Business Strategy or related field.
- 7+ years direct Outsourcing experience or a combination of relevant life cycle contracts management experience and at least 5 years direct Outsourcing site budget contracting experience.
- Experience with managing or participating in FMV activities.
- Excellent analytical, communication, written, and verbal skills.
- Proficiency in Contract, Finance, Legal and Business Acumen.
- Robust knowledge of the clinical trial lifecycle and experience working directly with clinical operations, legal, and finance.
- Experience interacting with a wide range of clinical sites, initiating and negotiating clinical trials contracts and budgets.
- Proven experience in managing all levels of key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into process improvements as appropriate.
- Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts, exercises good judgment in all forms of communication, multi-task and have an excellent attention to detail to ensure the most efficient and cost effective contract solutions are achieved.
- Proficiency in MS Excel, MS Word and Outlook a must.
- Ability to sustain high levels of performance in a constantly changing government.