Olema Oncology
Overview
Olema Oncology is a cancer medicines company focused on impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. For more information, visit www.olema.com. About the Role
Associate Director, Safety Sciences
— This role reports to the Senior Director of Safety Sciences and serves as a safety science expert to support the development of Olema’s products. You will work with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors. This position is based in either San Francisco or Boston and requires less than 10% travel. Responsibilities
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment Perform signal evaluation for identified safety signals and author safety evaluation reports Manage preparation and completion of safety documents, including DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc. Participate in and/or lead responses to regulatory inquiries and other risk management activities Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), including reviewing source documents, case narratives for accuracy, MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessments; assist Safety Operations staff in determining reportability Conduct literature search activities and develop key search strings for review information Support and attend Data Monitoring Committee (DMC) meetings, as required Support quality systems, inspection readiness, audits, and inspections Actively participate in process improvement initiatives, including development and maintenance of relevant SOPs Collaborate with cross-functional teams and external stakeholders, including business partners and safety vendors/contractors Apply effective communication to lead and facilitate safety team meetings Apply relevant FDA, EU, and ICH guidelines governing pharmacovigilance activities Ideal Candidate Profile
Knowledge MD, PhD in medical/biological sciences, PharmD, or RN degree Small Molecule and Oncology experience is essential Experience 5+ years (MD/PhD/PharmD) or 8+ years (RN) of pharmacovigilance/drug safety experience in biopharmaceutical industry Experience in process improvement initiatives and maintaining SOPs and supporting documents Ability to apply FDA, EU, and ICH guidelines governing pharmacovigilance activities Experience working with business partners and managing safety vendors Experience using safety databases for clinical/medical case review and basic queries Familiarity with clinical databases/EDC Experience mentoring and training junior team members Attributes Effective time management, prioritization, and ability to meet deadlines Strong verbal and written communication to convey safety findings clearly Analytical, problem-solving, strategic planning, and interpersonal skills Self-motivated, fast learner, and adaptable in a fast-paced environment Sound judgment, professionalism, and strong ethical standards The base pay range for this position is $195,000 - $210,000 annually, with variability based on location, market, knowledge, skills, capabilities, and experience. Total compensation includes equity, bonus, and benefits. #LI-MT1 We provide equal opportunity to all employees and applicants for employment and believe that great ideas come from a mix of expertise, background, and experience. Olema is building a culture where difference is celebrated. We offer a competitive compensation and benefits package and strive to provide an open, flexible, and friendly work environment to help employees 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. Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncology. Olema’s official email addresses end in @olema.com and our official website is oleva.com; our careers page is oleva.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Visit these links for official information. Olema does not conduct interviews via text or messaging platforms, will not ask you to download anything as part of your interview, will never request upfront payment, and will not make job offers without an in-person interview.
#J-18808-Ljbffr
Olema Oncology is a cancer medicines company focused on impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. For more information, visit www.olema.com. About the Role
Associate Director, Safety Sciences
— This role reports to the Senior Director of Safety Sciences and serves as a safety science expert to support the development of Olema’s products. You will work with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors. This position is based in either San Francisco or Boston and requires less than 10% travel. Responsibilities
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment Perform signal evaluation for identified safety signals and author safety evaluation reports Manage preparation and completion of safety documents, including DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc. Participate in and/or lead responses to regulatory inquiries and other risk management activities Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), including reviewing source documents, case narratives for accuracy, MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessments; assist Safety Operations staff in determining reportability Conduct literature search activities and develop key search strings for review information Support and attend Data Monitoring Committee (DMC) meetings, as required Support quality systems, inspection readiness, audits, and inspections Actively participate in process improvement initiatives, including development and maintenance of relevant SOPs Collaborate with cross-functional teams and external stakeholders, including business partners and safety vendors/contractors Apply effective communication to lead and facilitate safety team meetings Apply relevant FDA, EU, and ICH guidelines governing pharmacovigilance activities Ideal Candidate Profile
Knowledge MD, PhD in medical/biological sciences, PharmD, or RN degree Small Molecule and Oncology experience is essential Experience 5+ years (MD/PhD/PharmD) or 8+ years (RN) of pharmacovigilance/drug safety experience in biopharmaceutical industry Experience in process improvement initiatives and maintaining SOPs and supporting documents Ability to apply FDA, EU, and ICH guidelines governing pharmacovigilance activities Experience working with business partners and managing safety vendors Experience using safety databases for clinical/medical case review and basic queries Familiarity with clinical databases/EDC Experience mentoring and training junior team members Attributes Effective time management, prioritization, and ability to meet deadlines Strong verbal and written communication to convey safety findings clearly Analytical, problem-solving, strategic planning, and interpersonal skills Self-motivated, fast learner, and adaptable in a fast-paced environment Sound judgment, professionalism, and strong ethical standards The base pay range for this position is $195,000 - $210,000 annually, with variability based on location, market, knowledge, skills, capabilities, and experience. Total compensation includes equity, bonus, and benefits. #LI-MT1 We provide equal opportunity to all employees and applicants for employment and believe that great ideas come from a mix of expertise, background, and experience. Olema is building a culture where difference is celebrated. We offer a competitive compensation and benefits package and strive to provide an open, flexible, and friendly work environment to help employees 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. Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncology. Olema’s official email addresses end in @olema.com and our official website is oleva.com; our careers page is oleva.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Visit these links for official information. Olema does not conduct interviews via text or messaging platforms, will not ask you to download anything as part of your interview, will never request upfront payment, and will not make job offers without an in-person interview.
#J-18808-Ljbffr