Director, Development Business Operations
Foster City, CA, USA | Major Biopharmaceuticals Company
Industry:Pharmaceutical / Biotech
Job Description:51 people have viewed this job
Major Biopharmaceuticals Company, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
We are currently seeking a Director, Development Business Operations with expertise in clinical outsourcing of global Phase 1-4 clinical trials. The role is responsible for the entire life cycle of vendor selection, including RFI, RFP, vendor selection decision, contracting, monitoring performance, managing the change order process, and ensuring proper closeout of clinical agreements.The candidate will have a proven success record of working in a matrixed environment, and regularly collaborating with cross functional teams, such as, clinical operations, finance, legal, business conduct, and vendor management. In addition, the role will have excellent communication skills and is comfortable interacting with internal and external teams of all levels, including the Senior Management.This position will require the ability to apply critical thinking in performance of clinical vendor outsourcing, contract management and budget development including negotiation and drafting expertise, in a high volume, fast paced environment.
Ideal candidate will have strong managerial skills with demonstrated success in managing multiple direct reports, and working collaboratively with other cross functional groups to ensure the most efficient and cost effective contract solutions are achieved.
• May lead or manage the Development Business Operations department in support of senior management.
• Manages the day-to-day activities of multiple areas in complex clinical contracts and finance processes.
• Manages operational functions including supervising other staff who contribute to clinical contract management.
• Manages staff
• Participates in establishing departmental and cross-functional policies and procedures.
• Manages contract activities for multiple clinical development programs, ensuring that there is adequate staff with the skills to complete site and vendor contracts accurately, consistently, and in a timely manner.
• Provides information to Senior Management on contract and budget issues.
• Assists staff working on contracts in resolving complex issues relating to contract negotiation or management.
• Trains staff in contract budgeting, development, and administration.
• Manages study level vendor relationships in conjunction with the Clinical Operations, Bioanalytical Chemistry or Biometrics groups
• Works with internal customers in vendor bidding and proposal development (RFP creation and analysis)
• Manages Vendor bid defense meetings
• With the support of internal customers and the Legal department, manages the contract negotiation process, especially in more complex, or high value contracts
• Leads contract life cycle management process related to clinical vendors.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates an in-depth knowledge of clinical research functions.
• Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development.
• Demonstrates ability to interact on an advanced level with the clinical teams, corporate finance, and project management to provide oversight of clinical vendor budgets and related contractual terms.
• Completes tasks and projects under minimal supervision as well as demonstrates ability to make critical decisions related to projects and tasks of junior staff.
•Demonstrates all the skills of a Senior Manager
• Travel may be required
Knowledge, Experience and Skills:
-12 years of experience with a BA in a relevant discipline.
-10 years of experience with a MS in a relevant discipline.
-Relevant experience typically includes contract negotiation and/or clinical outsourcing
-.6 years of experience managing a team of 3 or more
- MBA or JD preferred
- PMP or CPSM certification a plus