Associate Director, Safety Operations

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 Operations

As the Associate Director of Safety Operations reporting to the Director of Safety Operations, you will routinely solve complex project management issues while assisting with the oversight of the daily operations of the Olema Safety team as well as manage safety reporting compliance.

This role may be based out of our San Francisco, CA or Boston, MA office and will require 5% travel.

Your work will primarily encompass:

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

Ideal Candidate Profile >>>

A love of challenging, important work. We 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

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

Experience

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

Attributes

• Ability to work independently, demonstrating initiative and flexibility
• Continuously seek opportunities to improve processes and systems related to drug safety
• Maintain confidentiality and adhere to ethical standards in all aspects of the job
• Strong verbal and written skills and demonstrated cross collaboration skills
  
  

The base pay range for this position is expected to be $195,00 - $210,00 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 olema.com; our careers page is olema.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.