Senior Clinical Trial Associate

Senior Clinical Trial Associate

Boston, Massachusetts

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It's an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

If you're ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what's beyond.

About the Role >>> Senior Clinical Trial Associate

As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines.

This role is based out of either our office in San Francisco or Cambridge office and will require approximately 10% travel.

Your work will primarily encompass:

• Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct
• Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors
• Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities
• Conducts oversight of sample collection, shipment, and analyses
• Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead
• Identifies potential risks and proactively resolves issues with CROs
• Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s)
• Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information
• Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents
• Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms.
• Coordinates electronic distribution and/or shipment of study-related materials, as appropriate
• Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed
• Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF)
• Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations
• Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes

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

• Bachelor's degree is required
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred
• Working knowledge of clinical protocols

Experience

• Minimum of 3 years of related industry experience is required
• Senior CTA requires 2 years' experience working as a Clinical Trial Associate.
• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)
• Experience with leading small group meetings and/or managing vendor relationships

Attributes

• Highly motivated and enjoys working in a fast-paced, dynamic environment
• Excellent teamwork and collaboration skills
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail
• Excellent written and verbal communication skills
• Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed

The base pay range for this position is expected to be $110,000 - $120,000 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.