Senior Manager, Clinical Business Operations

General Scope and Summary 

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for clinical contracting across Clinical Development. We are seeking a highly capable contracts manager with strong contract development and negotiating skills to support execution of drug development programs. This key role will report to the Director, Clinical Outsourcing and will be responsible for managing the processing of clinical contracts from the identification of need through drafting, review, negotiation, approval, execution, analysis, tracking, and reporting. This role will work closely with Sage’s Legal team with regard to negotiations of MSAs, CTAs, and other contract language as necessary.

This is an exciting and interdisciplinary role for a qualified, organized, and motivated individual.

Roles and Responsibilities

• Outsourcing - Vendor Selection and Negotiation: Accountable for employing expert levels of competency in negotiating value delivery of contracting and outsourcing solutions in support of the Sage Clinical Development organization for the evaluation and selection of service providers (project scope determination, preparation, distribution, and management of RFIs and RFPs, bid analysis and scoring, and recommendations for selection). This position will take a lead role in negotiating value with key suppliers and assisting functions in clearly defining the services required, including managing highly complex negotiations and efficiencies with key suppliers.

• Vendor/Consultant Contract Preparation and Negotiations: Review contract documents, ensuring the use of appropriate templates and adherence to Master Service Agreement terms as applicable. Negotiate budget and contract terms as needed. In collaboration with the Legal department and Director, Clinical Outsourcing, ensure that final contracts cover the necessary scope and are consistent with company requirements, applicable regulations, and good business practices. Manage the contract execution process according to Sage requirements. Advise internal customers on appropriate type of agreement to address their needs.

• Site Contract and Budget Preparation and Negotiations (future state): Support the development and maintenance of clinical trial site reference budgets through the management and use of licensed or internal benchmarking tools. Liaise with internal Clinical Operations leads, Legal, and CRO partners to develop site budget negotiation parameters and approval of site contract templates.

• Process and Template Development: Support development and updating of Sage’s processes and tools, including request for proposal and contract templates. Participate in corporate initiatives.

• During all stages of activities, interact with internal customers, Procurement, Legal and Finance departments, and other functions as appropriate, managing high volume of contract requests to meet project timelines.

• Provide effective communication and recommendations to the business with support from the SME to ensure Sage receives the best value for the contracted service. Participate in the development and successful execution of contract implementation plan, which includes implementing the sourcing strategy to ensure timelines are met while maintaining compliance with all applicable policies and procedures.

• Actively monitor study progress for possible changes in study scope to ensure timely change order implementation and finalization, utilizing advanced knowledge to drive the negotiation of the change orders and associated costs to minimize the risk to Sage. Manage expectations and mitigate risk by providing strategic solutions for issues and execute final agreements/change orders with minimal guidance and support.

• May provide leadership and guidance to develop other team members via mentoring and coaching.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• Degree in scientific, economic, or legal discipline, or equivalent, with 5+ years pharma/biotech/CRO industry-related experience or equivalent, to include at least 5+ years of experience in clinical contract negotiation and finalization.

• 5-7 years of experience in clinical research and development.

• Bachelor’s degree required. Advanced degree preferred (JD/MS/MA/MBA).

Preferred Qualifications

• Solid understanding of global clinical trials and drug development, including in clinical pharmacology, phase I through phase IV (post-marketing).

• Excellent leadership skills, including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.

• Demonstrated understanding of project management principles as well as sound knowledge of contract terms and conditions, benchmarking, and market analysis skills; must have high degree of energy, accuracy, and attention to detail.

• Outstanding communication skills, including excellent verbal and written communication skills, an innovative approach to problem-solving, with complex negotiation and conflict resolution skills.

• Must possess good organizational and interpersonal skills as well as great attention to detail.

• Ability to thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient is essential.

• Ability to work independently and successfully in a matrix environment as well as prioritize and manage multiple tasks simultaneously.

• Skilled at developing and maintaining professional interpersonal relationships with colleagues internally and externally in order to complete the given tasks.

• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

• Strong team player that has a customer service approach and is solution-oriented.

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• Strong hands-on knowledge of Microsoft Excel, Word and PowerPoint; SharePoint experience a benefit.

• Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

• Ability to integrate cross-functional issues and balance competing priorities effectively.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

EEO is the Law - Poster Supplement

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.