Senior Specialist, Clinical Business Operations

MapLight Therapeutics•Burlington, MA

4d•Hybrid

About The Position

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. MapLight is looking for a dynamic and experienced Senior Specialist, Clinical Business Operations. Reporting to the Executive Director, Clinical Operations, the Senior Specialist will be responsible for supporting all aspects of clinical business operations, including vendor selection, contracts, budget management and performance metrics. The ideal candidate will streamline operational procedures across multiple projects to improve timelines and organization of data.

Requirements

Bachelor’s Degree or equivalent education required, preferably in Life Sciences, Finance, or Business Administration.
A minimum of 3 years experience with outsourcing for clinical trials, vendor negotiations, or operations management, accounting, and finance.
Experience working with key Clinical Operations stakeholders.
Excellent written and oral communication skills with ability to generate concise reports and verbal updates.
Demonstrated strong analytical skills.
Demonstrated high level of proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
Must be flexible and adaptable to changing project priorities, work assignments and deadlines.

Nice To Haves

Experience working with the biotech/pharmaceutical industry at a CRO or sponsor company preferred.

Responsibilities

Vendor selection; including review and analysis, budget negotiations, development, and execution.
Manage the Request for Proposal (RFP) process. This includes: Work with Clinical Trial Managers (CTM) and Clinical Scientific Leads to develop outsourcing strategy including range of vendors and timelines for award (i.e. schedule a vendor outsourcing strategy meeting). Use the RFP template to customize to each study. Create a draft of the RFP for review by the study team. Communicate with vendors the RFP timelines and milestones and coordinate feedback to questions/answers. Maintain the internal RFP timelines and milestones. Following award, be the point of contact to receive the scope of work and budget grid from vendor. Coordinate the review and consolidate the internal study team’s (and finance) questions and comments regarding the budget to the vendor. Coordinate contract review and Coupa entry of budget. Initiate a warm transfer to the operations team.
Manage MapLight’s review of all site budgets and contracts. This includes: Lead discussions with vendor and CTM to develop study budget and acceptable ranges. Forecast site contract review timelines as they related to study start up with assistance from the study CTM. Laise with the Legal Department to ensure MapLight specific site contract template with fall back language is acceptable. Coordinate with CRO/vendor for process of escalation language to MapLight. Coordinate with study team on internal process for triage of contract language and budget requests. Provide and/or track contract status updates/reporting. Ensure all executed site contracts are filed in the designated area within MapLight.
Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality Agreements, Master Services Agreements, Work Orders, Amendments, Change Orders, and any other type of contracts) needed for clinical studies.
Actively managing other clinical financial obligations.
Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms and partner in collaboration with Legal, Finance and other internal stakeholders as needed to finalize.
Builds and maintains business relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships.
Innovate and maintain tracking systems and metrics, translating complex data into actionable insights for project and program advancement.
You can participate and work effectively with multiple cross-functional teams.
You have strong interpersonal skills and understand relationships are key to being successful.
You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
You’re a team player who is willing to roll-up your sleeves and get the job done.