Job Details

Overview

Olema Oncology is a cancer medicines company focused on 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 group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit www.olema.com.

Role

Associate Director, Safety Operations. This role reports to the Director of Safety Operations and involves solving complex project management issues, overseeing daily operations of the Olema Safety team, and managing safety reporting compliance. The position may be based in San Francisco, CA or Boston, MA and requires 5% travel.

Responsibilities

• Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners within timelines and according to SOPs.
• Managing safety reporting compliance.
• Drafting and reviewing pharmacovigilance documents.
• Preparing metrics related to safety reporting and reporting to upper management as needed.
• Collaborating with cross-functional teams (Clinical Operations, Data Management, Biostatistics); participating in meetings and teleconferences with CROs and business partners.
• Managing vendors, audit and inspection readiness, pre-launch activities, pre-commercial and commercial launch operations, and NDA safety operations.
• Assisting with study start-up and management of new/future studies.
• Spearheading the development of departmental systems including SOPs and guidelines.
• Training internal and external groups in Pharmacovigilance principles and best practices.
• Working with safety vendors on daily operations tasks and implementing key action items.

Ideal Candidate Profile

Knowledge

• BA/BS degree in life sciences, pharmacy, nursing, or related field.
• Previous experience with drug safety databases.

Experience

• 7-10 years of pharmaceutical industry experience, of which 5 years are in safety.
• Broad clinical/medical knowledge, pharmacovigilance expertise, and technical system proficiency.
• Strong understanding of good pharmacovigilance practices and current global regulations (EU, US, Canada), clinical trial methodology, and GCP.
• Well-developed presentation, communication, and interpersonal skills; strong written and oral communication.
• Experience managing external vendors and audit/inspection readiness, pre-commercial and commercial launch readiness.
• Strong organizational, project management, technical, and problem-solving skills.

Attributes

• Ability to work independently with initiative and flexibility.
• Continuous improvement mindset for processes and systems related to drug safety.
• Maintain confidentiality and adhere to ethical standards.
• Strong verbal and written skills and demonstrated cross-collaboration abilities.

The base pay range for this position is expected to be $195,00 - $210,00 annually; however, the base pay offered may vary by location, market, knowledge, skills, capabilities, and experience. Total compensation includes equity, bonus, and benefits.

EEO & Benefits

We provide equal opportunity to all employees and applicants for employment and believe that great ideas come from diverse backgrounds. Olema is building a culture where difference is celebrated. We offer a competitive compensation and benefits package and a summary of benefits is available for all applicants.

Fraud Alert

Note: Olema does not accept agency resumes and is not responsible for fees related to unsolicited resumes. Our official information is available at olema.com and careers at olema.com/careers; be cautious of communications from other variants claiming affiliation with Olema Oncology.

Apply for this job

To apply, please visit our careers page at www.olema.com/careers and submit your application as prompted.