Olema Oncology
Associate Director, Safety Sciences
Olema Oncology, San Francisco, California, United States, 94199
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Associate Director, Safety Sciences
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Olema Oncology 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. Overview
About the Role:
Associate Director, Safety Sciences , reporting to the Senior Director of Safety Sciences, you will serve as a safety science expert to support the development of Olema’s products. This role is based out of our San Francisco or Boston office and will require 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 signal 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/lead responses to regulatory inquiries and other risk management activities Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), as required, including reviewing source documents, reviewing case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessment, and assisting Safety Operations staff in determining reportability Conduct literature search activities and develops key strings for search criteria and review information Support and attend Data Monitoring Committee (DMC) meetings, as required Support quality systems, inspection readiness, audit, and inspections Actively participate in process improvement initiatives, e.g. the development and maintenance of relevant SOPs Work effectively with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors Apply effective communication skills to lead and facilitate safety team meetings Apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities Qualifications
Knowledge : MD, PhD in the field of medical/biological science, PharmD, or RN degree Small Molecule and Oncology is a must Experience : 5+ (MD, PhD, PharmD) or 8+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities Experience working with business partners and managing safety vendors Ability to work with the safety database for purposes of clinical/medical case review and simple queries Familiar with the clinical database/EDC Experience mentoring and teaching new/junior team members Attributes : Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines Strong verbal and written skills to convey safety findings and recommendations with clarity Excellent analytical, problem-solving, strategic planning, and interpersonal skills Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization Demonstrates sound judgment, professionalism, and strong ethical standards Compensation and Benefits
The base pay range for this position is expected to be
$195,000 - $210,000
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. Important Information
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. Fraud Alert : 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 olem a.com; our careers page is olem a.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview. Locations & Roles
San Francisco, CA or Boston, MA San Francisco, CA $100,000.00-$250,000.00 6 days ago San Ramon, CA $164,000.00-$180,000.00 3 weeks ago
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Associate Director, Safety Sciences
role at
Olema Oncology 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. Overview
About the Role:
Associate Director, Safety Sciences , reporting to the Senior Director of Safety Sciences, you will serve as a safety science expert to support the development of Olema’s products. This role is based out of our San Francisco or Boston office and will require 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 signal 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/lead responses to regulatory inquiries and other risk management activities Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), as required, including reviewing source documents, reviewing case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessment, and assisting Safety Operations staff in determining reportability Conduct literature search activities and develops key strings for search criteria and review information Support and attend Data Monitoring Committee (DMC) meetings, as required Support quality systems, inspection readiness, audit, and inspections Actively participate in process improvement initiatives, e.g. the development and maintenance of relevant SOPs Work effectively with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors Apply effective communication skills to lead and facilitate safety team meetings Apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities Qualifications
Knowledge : MD, PhD in the field of medical/biological science, PharmD, or RN degree Small Molecule and Oncology is a must Experience : 5+ (MD, PhD, PharmD) or 8+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities Experience working with business partners and managing safety vendors Ability to work with the safety database for purposes of clinical/medical case review and simple queries Familiar with the clinical database/EDC Experience mentoring and teaching new/junior team members Attributes : Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines Strong verbal and written skills to convey safety findings and recommendations with clarity Excellent analytical, problem-solving, strategic planning, and interpersonal skills Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization Demonstrates sound judgment, professionalism, and strong ethical standards Compensation and Benefits
The base pay range for this position is expected to be
$195,000 - $210,000
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. Important Information
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. Fraud Alert : 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 olem a.com; our careers page is olem a.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview. Locations & Roles
San Francisco, CA or Boston, MA San Francisco, CA $100,000.00-$250,000.00 6 days ago San Ramon, CA $164,000.00-$180,000.00 3 weeks ago
#J-18808-Ljbffr