Job Overview

Danforth Advisors deploys Preclinical Study Outsourcing Directors to support identification, selection, and negotiation of outsourcing for non-clinical and research studies for emerging biopharma clients. Typically, consultants balance the demands of a few clients at a time, with the combined hours equating to a full-time position. This is an excellent opportunity to work with high growth, dynamic players in Clinical Operations and should have a proven ability to effectively manage multiple preclinical projects and timelines simultaneously.

Potential Responsibilities
The Consultant will provide accounting services, including, but not limited to:

• Partner with preclinical program team members to create specifications for work to be outsourced.
• identify and assess candidate vendors based on capabilities, capacity, strategic fit and expertise.
• Lead RFP process (including vendor evaluation and vendor selection) for preclinical service providers (CROs, GLP and non-GLP labs and other preclinical vendors) for new clinical studies of various phases and sizes and complexity and risk. Includes assessing vendor capabilities.
• Lead the study teams through the process of analyzing complex budget scenarios, bids, and outsourcing models to determine best value and best fit.
• Manage and lead negotiations with external service providers including analysis of complex, detailed scopes of work, exhibits, payment terms, budgets, MSAs and Change Orders.
• Work closely with other functional areas (including Toxicology, DMPK, Bio-analysis, Biology, Pathology, CMC, Program Management, Finance, Legal, Chain Supply, Sample Management).
• Facilitate planning, negotiation, development and tracking of timelines for nonclinical outsourced studies.
• Provide oversight of vendors to ensure management of the project’s scope, contract, and finances.
• Ensure that any contractual changes in scope are communicated, negotiated, documented, and transparently proportional to actual activity or incurred cost.
• Manage vendor relationships and oversee vendor to ensure compliance against contracted services, including receipt of results, for outsourced work and escalate issues as appropriate.
• Evaluate and optimize/enhance key business processes and establish best practices with internal and external stakeholders and business relationships.

Requirements

• 5+ years of experience in preclinical research environment or comparable applicable experience; understanding of scientific terminology, business practice, process, timeline, and key budget drivers
• Previous experience working with Sponsors, CROs and other service providers in preclinical research is required.
• Contract management and negotiation experience required (budget and business terms and conditions)
• Proven ability to build and maintain effective internal and external relationships
• Must have strong analytical, negotiating and business communication skills
• Must be self-motivating and be able to prioritize and manage a large volume of work, handle a moderate amount of pressure, and show attention to detail
• Proficient with Microsoft Office
• Experience and confidence working with multiple functional areas and facilitating communication across multiple levels of internal/external teams.
• Knowledge of global regulatory guidelines (ICH/GLP/OECD) is a plus
• Previous experience in conducting laboratory animal research studies a plus.
• Working knowledge of invoicing/accounting/contract management required.

Benefits

• Competitive Pay
• Flexible hours (Part-time and Full-time)
• Ability to work remote
• Health Care Plan (Medical, Dental & Vision)

About Danforth Advisors

Danforth Advisors is the financial and operational backbone to hundreds of life science companies, providing integrated and scalable consulting teams ranging from staff accountant through CFO. The company’s services span the full breadth of a finance organization’s needs, whether short or long term, including accounting and operational finance support, capital raising, financial planning and analysis, IPO preparation, post-public SEC compliance, risk and insurance management, clinical business operations management and strategic and operational human resources. Founded in 2011, Danforth has been a strategic and trusted thought partner to private and public life science companies across all stages of corporate evolution. The company serves clients nationwide from its headquarters in Waltham, Massachusetts and regional bases in New York, Philadelphia and San Francisco. Additional information is available at www.danforthadvisors.com.