Director, Clinical Operations

The Role: 

We are looking for a strategic Director of Clinical Operations to lead the planning and execution of the operational strategy of Olema Oncology clinical trials. Reporting to the Sr. Director, Clinical Operations, this individual will be an experienced, strategic late phase oncology clinical operations leader responsible for project and trial planning, budgeting and financial oversight, staff and contract research organization (CRO) management, program/trial clinical operations, leading clinical study teams, timelines, GCP compliance and inspection readiness activities. 

This is a fantastic opportunity for an experienced and capable leader to join a company with an industry leading Board of Directors and Management team, participate in defining operational strategy for Olema’s studies and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.   

This is a highly visible role within the organization and requires working on site at either our Cambridge or San Francisco office at least two days a week in a hybrid model with the ability to travel up to 15% .

What You Will Do: 

• Provide strategic leadership and direction to study teams and is accountable in the planning and execution of clinical trials to meet timelines and quality deliverables in accordance with corporate study goals
• Oversee global harmonization of study processes and CRO/vendor activities, ensuring transparency and consistency across Clinical Trial Leads as well as the study execution team
• Independently manage and oversee budgets and timelines, reporting and justifying study metrics to product teams and executive management; participate in financial forecasting, accruals, and reconciliations
• Establish and/or implement best trial management practices, standards, systems and SOPs in collaboration with other members of the clinical operations and cross-functional teams
• Ensure that clinical trials are conducted in compliance with the protocol and applicable regulatory requirements and oversee/drive/collaborate on inspection readiness activities
• Contribute to the development of protocols, Investigator Brochures, DSURs, and clinical study reports; oversee the creation of project plans, study manuals, and trial tools
• Present Clinical Operations strategy and updates to Olema’s program team(s), senior leadership and executive committee
• Successfully establish strong relationships, working in partnership with key stakeholders across Olema
• Seek alignment within the organization to maximize the delivery of outputs to achieve the overall clinical operations strategy
• Bring a “can-do” attitude while being able to respectfully challenge partners and be assertive, when necessary, with project timelines, finances, and scope; stretch Clinical Operations and other clinical departments to deliver more, while also serving as a gatekeeper for new initiatives and studies when it comes to feasibility, regulatory issues, and prioritization within overall budget and resource constraints
• Directly lead, coach, and mentor Olema Clinical Operations staff: Ensure the recruitment and development of the right talent and Oncology therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talent
• Seek to continually raise the bar for the operationalization of Olema oncology study teams, driving timeline and resource efficiency, and ensuring information is captured, retained and shared across functions to leverage in future work
• Develop and implement strategic CRO and vendor selection and provides management and documented oversight; accountable for resolving vendor issues that need to be addressed at the executive level

What You Will Bring: 

• A minimum of 12 years of bio-pharmaceutical industry experience in a global pharma organization delivering medicines/therapies to a broad market across various therapeutic areas including at least 4 years’ experience managing direct reports
• Bachelor’s Degree or higher in a scientific discipline or previous experience working directly in a sponsor clinical research setting
• Broad knowledge and track record of successfully managing clinical trial operations through all stages of the drug development lifecycle. Knows what can go wrong and how to proactively prepare for all possible outcomes
• Successfully led a global phase 3 oncology clinical trial
• Direct experience in oncology clinical research across all stages of development
• Exhibited experience in delivery of study enrollment
• Strong experience managing multiple CROs/vendors to successful outcomes
• Big picture and strategic thinker: can formulate a vision of future state and lead the organization to build tactical plans to achieve this
• Experience implementing large-scale change and process improvements relating to clinical trials
• Experience with financial planning and resource management
• Excellent collaborator: easily builds relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a matrixed organization
• Excellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvements
• Experience leading teams and managing and developing talent
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project or Smartsheet for development and update of clinical study timelines

The base pay range for this position is expected to be $220,000 - $230,000 annually, 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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