Associate Director, Study Contracts Management

Location
Redwood City, CA
Posted
Apr 30, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
The Associate Director, Study Contracts Management is responsible for overseeing assigned areas of the Contract Management (CM) group.  The Associate Director is responsible for overseeing the planning, management and implementation of contract management activities performed in assigned area.  The Associate Director also creates, negotiates and execute contracts, contract amendments and budgets.
What you’ll do:

 
About you:

What you'll do:
  • Provide oversight of the Clinical Trial Agreement (CTA) Management process, including developing and maintaining the core contract template(s) supporting R&D trials.
  • Develop CTA per patient budgets using Grant Plan
  • Draft and maintain study-specific CTA templates
  • Finalize CTA templates and per-patient budgets with study teams.
  • Negotiate and establish pre-approval and approval workflows; review roles, task timelines, and responsibilities; and negotiate parameters with study teams.
  • Draft, negotiate and execute site-specific CTAs within established study timelines and budget.
  • Develop, draft and negotiate CTA amendments within established study budgets
  • Assist and manage the Data-Driven Payment process for assigned studies
  • Lead and coordinate CTA management for large studies
  • Lead and coordinate CTA management for all studies within a project.
  • Answer questions and resolve problems concerning all assigned studies and individual contracts
  • Track workflow and contract costs for assigned studies and individual contracts
  • Ensure contracts are executed within fair market value (FMV) standards as appropriate
  • Work with Clinical Planning on coordinating study timelines and identifying critical path milestones.
  • Ensure contracts are executed in compliance with applicable SOP and policy.
  • Lead Contract Management Optimization            
  • Contribute to defining and achieving CMG goals and objectives
  • Identify process-related issues, propose solutions and implement process improvements
  • Identify and build metric reporting, tools, and processes to optimize contract management and supplier sourcing.
  • Identify risks and issues and suggest alternative solutions
  • Create and promote internal customer alliances and partnerships.
  • Develop and maintain CMG procedures and SOPs.
  • Lead the development and maintenance of a resourcing model to ensure CM resource support across R&D projects.

About you:
  • BA/BS Degree in Business or Life Sciences, MBA preferred
  • 10+ years of significant experience in a related or subordinate role and experience creating, negotiating, and executing contracts in the pharmaceutical or biotech industry required.
  • Management of direct reports at multiple sites/countries preferred.
  • Professional certifications (Six Sigma, CPA, JD, etc.) preferred
  • Excellent knowledge of GCP and regulatory requirements for clinical trials
  • Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Microsoft Project, and Adobe Acrobat Professional. Experience with Microsoft Access is a plus
  • Ability to travel up to 10% of the time both domestically and internationally

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation