Manager, Contracts

Contracts Manager, R&D Legal (Clinical)

We are looking for a Contract Manager to support our clinical trial programs.  The Contract Manager will be responsible for providing contract management to support Alnylam’s clinical trials. The Contract Manager consults and collaborates with legal counsel, business contract owners, key Alnylam stakeholders (i.e. compliance, privacy, procurement, operations), CROs and clinical trial sites globally.  This individual will also be responsible for timely preparation, drafting, negotiation and administration of contracts.  

The successful candidate will have strong contract and budget negotiation, contract management, organization and communication skills.  The successful candidate will be distinguished by their ability to negotiate a high volume of research agreements with attention to detail.  The successful candidate will be distinguished in their ability to collaborate with Clinical Operations, Development and the Legal team to prioritize agreements, as well as execute contracts and other strategies.  It is expected that the Contract Manager will be a highly effective collaborator and communicator. A successful candidate will have a positive attitude and be effective in a fast-paced environment.

Summary of Key Responsibilities

Contract Negotiations and Reviews

• Review and negotiate confidentiality agreements (CDAs), Clinical Trial Agreements (CTAs), Informed Consents (ICFs), and study-related ancillary documents (including, but not limited to, Pharmacy Agreements, Privacy-related agreements, and Letters of Indemnification) either directly or as escalated by CROs. 
• Identify and escalate contract terms to appropriate business owners, attorneys, and other appropriate stakeholders, in a timely manner.
• Build strong working relationships with CRO contracting staff, as well as, contracting staff at medical institutions to facilitate quick contract executions and conflict resolutions to ensure efficient conduct of clinical trials.           
• Track and drive contracts to resolution, including identifying remaining contracting issues, identifying appropriate stakeholders to reach decisions, and convening meetings to drive efficient decision-making.
• Identify and effectively communicate priorities and urgencies to applicable stakeholders.
• Participate in cross-functional teams to ensure contract executions and strategies are achieving targeted goals 
• May assume responsibility for developing and negotiating clinical site budgets in accordance with Fair Market Value, as well as negotiating related agreement language with clinical study sites.

Contract Administration / Operational Management

• Serve as an expert in Alnylam's contract management system and processes.
• Work closely with Legal Operations and contract management system team to ensure contracts are properly managed in system and develop enhancements, improvements and updates.
• Partner with GTSO and other colleagues to address and solve day-to-day contracting issues and proactively troubleshoot and implement short-term and long-term contract improvements and efficiencies.
• Support and manage contract templates and guidelines, as requested. Track negotiated terms across agreements and identify potential updates to contracting guidelines.
• Propose updated contracting guidelines, as needed.

Qualifications

• Undergraduate degree.
• Minimum 3 years of contracting experience.
• Experience negotiating CDAs, CTAs, legal aspects of ICFs and study-related ancillary documents either in a pharmaceutical/biotech company or CROs.
• Experience negotiating budgets.   
• Experience negotiating within contract management system (CMS) required.
• General understanding of applicable laws and regulations, as well as, legal risks, impacting research and development at a commercial-stage, biotech company (including confidentiality, intellectual property, anti-kickback/anti-bribery laws, GCP/ICH, FDA regulations, privacy laws)
• Strong written, oral communication, interpersonal, and organization skills.
• Ability to work independently, as well as in a team environment.
• Ability to effectively prioritize workload and communicate priorities.
• Ability to work and adapt in a complex, dynamic organization handling multi-faceted projects