Job Details

Senior Director, Clinical Business Operations

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com .

About the Role >>> Senior Director of Clinical Business Operations

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 office San Francisco or Cambridge office and requires approximately 10-15% travel.

Your work will primarily encompass:

• 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

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge experience , and attributes for this role.

Knowledge:

• 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

Experience:

• 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

Attributes:

• 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

The base pay range for this position is expected to be $225,000 - $265,000annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Additional Note/Fraud Alert

Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,

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