Sr. Manager/ Associate Director, Clinical Contracts & Budgets

South San Francisco, California, United States
Aug 09, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

This position will report to Senior Vice President Development Operations and provide oversight, guidance and management of clinical contract and budget activities including:
• Managing and assisting in the finalization of clinical contract templates and customizing templates for distribution to external parties.
• Reviewing, tracking and negotiating contracts (within established parameters with Principia legal) with external parties to support the company's clinical development operations, including but not limited to clinical trial agreements, confidentiality agreements, service agreements, statements of work, consulting agreements, license agreements, amendments, budgets and change orders.
• Establishing and managing tracking workflows for review and approval of a variety of clinical contracts and agreements and proactively managing the contractual and related legal needs for the clinical trials
• Collaborating cross-functionally to proactively manage and address the contractual needs of internal stakeholders in each contract
• Acting as a single point of contact for, the clinical team and other internal stakeholders and as well as provide guidance and alternative language to external contract specialists on clinical contract matters
• Establishing an accurate tracking and record-keeping of contracts
• Ensuring alignment with the company's contracting standards, driving the timeliness of contracting activities and operational efficiency
• Establishing invoice tracking for the contracted budget in conjunction with the clinical trial manager and finance to ensure understanding of budget to actual, project potential risk for change orders, and facilitate timely payment of invoices
• Assisting with special projects as needed related to contract and budget management and processing

• Bachelor's degree required
• Minimum 5 years of experience reviewing, drafting and negotiating the legal provisions of contracts in the biotechnology or pharmaceutical industry including at least 3 years of experience focused on clinical trial agreements
• Expertise in clinical contracting terms and legal requirements for clinical trials
• Ability to understand and analyze legal contractual terms, accurately identify and assess the risks in a business arrangement, make decisions with respect to contract content that are in alignment with the company's risk tolerances and contracting standards, and offer a practical, business-minded approach to contract negotiation
• Personable collaborator who can work successfully and build relationships with internal stakeholders and external parties to achieve business goals while managing risk
• Flexible and adaptable to shifting deadlines and priorities; able to effectively prioritize and manage a large volume of contract assignments
• Strong organizational and administrative skills; must have attention to detail and excellent proofreading skills
• Effective and professional verbal and written communication skills