Olema Oncology

Director, Clinical Science

San Francisco, California · Director

Sponsorship not specified$220k-$245kDetected 7 days ago

GCPPharmacologyFDA RegulatoryCommunicationCollaborationPublic SpeakingAdaptabilityBiostatistics

About the role

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.
OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients.
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.

Writing of technical and clinical documents including protocols, amendments, investigator's brochures, and the clinical sections of regulatory documents
Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols
Organizing and performing the study level and individual subject level analysis of the clinical trial data to gain insights and develop strategies for the clinical study report (CSR) writing
Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions

Advanced degree such as a PhD or PharmD is strongly preferred
Experience in oncology clinical development is required
Comprehensive knowledge of oncology clinical trial implementation and drug development process
Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones
A minimum of 8 years' experience in biotech/pharmaceutical industry is required
Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines
familiarity with other international regulatory requirements is a plus
Proactively identifying challenges/problems and proposing solutions with a strong sense of urgency

The base pay range for this position is expected to be $220,000 - $245,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.

Evaluate the safety, pharmacology, and efficacy of ongoing studies in close collaboration with the medical monitor and the safety, pharmacology and clinical operations teams
Collaborating with the Medical Monitor on review of enrollment packets, clinical development plans and scientific presentations

We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers.
To protect yourself, please note that Olema's official email addresses end in @olema.com.
Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is <a class="x_Hyperlink x

This listing is sourced directly from Olema Oncology's careers page and normalized into a canonical job model.