Senior Director, Clinical Business Operations

Olema Oncology•Boston, MA

46d•$225,000 - $265,000•Hybrid

About The Position

As the Senior Director of Clinical Business Operations, reporting to the SVP of Clinical Operations, your work will primarily support the Clinical Department’s initiatives to contribute to the success of our clinical trials. Your deep experience in vendor management and contracting will develop our global clinical outsourcing strategy. This role is a key partner to the clinical study teams, organizing the selection of service providers, coordinating requests for proposal and bid defenses, and negotiating work orders/change orders. This role is based out of either our San Francisco or Cambridge office and requires approximately 10-15% travel.

Requirements

BS or MS in a relevant discipline is required
Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions
Legal, financial, clinical operations, and regulatory acumen
Strong skills in the following: writing, critical analysis/evaluation, benchmarking, contracting, and negotiating
Strategic and integrative thinker to establish norms for Outsourcing across the Clinical Department
Knowledgeable of ongoing and new development clinical programs
Excellent knowledge of the costs of clinical procedures, and how to process the data for estimating of clinical programs
Strong skills in computer systems and software to manage contracting, finance, and invoice processing
A minimum of 15+ years of experience working in clinical research, biotech, and/or pharmaceutical company
Experience managing clinical outsourcing or procurement professionals
Expertise in building RFPs and leading the vendor selection process
Strong experience in vendor and site CTA contracting/budgeting, FMV assessment, Scientific Collaborator engagement to conduct clinical trials
Experience in providing thought leadership and consistent customer service
Expertise in the clinical contracting process, including but not limited to the following: Confidentiality Disclosure Agreements (CDAs), Scope of Work (SOW), FMV assessment, contract negotiations and management, Work Orders, Change Orders, and the Budget process
Demonstrated leadership skills while working in a fast paced and changing environment
Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working
Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines
Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific, legal, financial, and operational perspectives
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations
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
Excellent skills in negotiation/influence, management, grant/contract administration, written, and oral communications

Responsibilities

Oversee communication with clinical vendors regarding contracts, scope of work, and budgets
Lead the Request for Proposal (RFP) and vendor bidding process for clinical trials, including writing of RFP, bid comparison analysis, manage bid defense meetings, and vendor scorecard development
Manage the identification of service providers for clinical studies in collaboration with the study management teams and clinical departments
Liaise with the legal and financial groups on the vendor contract and purchase order process for the Clinical Department and negotiate terms of contract as needed
Work with clinical department partners to build the Scope of Work (SOW) for the contract including negotiation of costs
Review all change notification forms (CNFs) and Change Orders (COs) with contract manager and finance to ensure that correct pricing is established
Liaise with the legal and financial groups on the vendor contract and purchase order process for the Clinical Department
Establish strong partnerships with the clinical vendors to understand contracting challenges and develop simplified and collaborative resolutions to these challenges
Drive the Fair Market Value (FMV) process through working with the study teams and vendors to analyze and negotiate the final work order and subsequent change orders
Establish and manage the vendor governance process with key clinical vendors. Document key decisions and action plans and ensure compliance with the decisions established in governance meetings
Work with study teams to establish KPI process and help establish standard clinical vendor Key Performance Indicators (KPIs) to enhance vendor oversight and performance
Collaborate with legal and clinical operations teams to establish template clinical site contracts/clinical trial agreements (CTAs)
Interact with finance and clinical operations teams to build template site budget utilizing a FMV tool. In some studies, may help negotiate these budgets with clinical sites
Attend Study Execution Team (SET), monthly budget, and clinical meetings. This person may be asked to present at these meetings as needed
Provide insight and feedback at Clinical Operations Leadership Team
Lead in clinical outsourcing process/tool development, improvement, and implementation