Olema Oncology
Associate Director, Safety Sciences
Olema Oncology, Boston, Massachusetts, us, 02298
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.
About the Role
>>>
Associate Director, Safety Science
As the
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. You will work effectively with cross-functional teams across the organization as well as with external stakeholders, such as business partners and safety vendors/contractors.
This role is based out of our
San Francisco
or
Boston
office and will require less than 10% travel.
Your work will
primarily
encompass:
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, RMPs, and safety sections of protocols, IBs, ICFs, briefing books, 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 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 Ideal Candidate Profile
>>>
Key Requirements
A love of challenging, important workWe 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:
PhD in the field of medical/biological science, PharmD, or RN degree Expe
rience:
5+ (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 Experience 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 be proactive and self-disciplined, you can meet deliverable timelines, and effectively use your time and prioritize Ability to effectively communicate (verbal and written) safety findings 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 Have impeccable professional ethics, integrity, and judgement
The base pay range for this position is expected to be $185,000 - $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.
#LI-SB1
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.
Additional Note/Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.
About the Role
>>>
Associate Director, Safety Science
As the
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. You will work effectively with cross-functional teams across the organization as well as with external stakeholders, such as business partners and safety vendors/contractors.
This role is based out of our
San Francisco
or
Boston
office and will require less than 10% travel.
Your work will
primarily
encompass:
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, RMPs, and safety sections of protocols, IBs, ICFs, briefing books, 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 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 Ideal Candidate Profile
>>>
Key Requirements
A love of challenging, important workWe 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:
PhD in the field of medical/biological science, PharmD, or RN degree Expe
rience:
5+ (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 Experience 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 be proactive and self-disciplined, you can meet deliverable timelines, and effectively use your time and prioritize Ability to effectively communicate (verbal and written) safety findings 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 Have impeccable professional ethics, integrity, and judgement
The base pay range for this position is expected to be $185,000 - $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.
#LI-SB1
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.
Additional Note/Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.