Vice President, Pharmacovigilance and Safety Sciences

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

About the Role >>> Vice President, Safety Sciences and Pharmacovigilance

Safety Sciences and Risk Management

• You will develop and execute the company’s global product safety strategy to ensure proactive risk management and compliance with local and international PV regulations
• You will oversee Olema’s safety activities and collaborate and partner with clinical and regulatory teams to integrate safety insights into product development, clinical trial design, and labeling strategies
• You will maintain robust safety governance structures, ensuring alignment with company objectives and industry best practices
• You will develop, lead and oversee timely safety evaluation and risk management strategies for clinical products, including benefit-risk assessments, aggregate reporting, and product safety strategy, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns.
• You will lead safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries
• You will lead the development of safety regulatory reports and safety related sections of clinical documents (e.g. study protocols, ICFs, IBs, ISS, product package labeling, Core Safety Information)
• You will act as Safety representative for interactions with regulatory authorities and internal and external stakeholders
• You will engage with external medical and scientific experts, IDMCs, and scientific / industry groups

Safety Operations 

• You will oversee the Safety Operations team and work closely with them to ensure compliance with related policies, procedures, applicable regulations, and agreements with contractual partners
• You will provide medical oversight of the Safety Operations including but not limited to medical review of case narratives and causality assessments of safety reports
• You will lead analysis of similar events, individual case comments, RMPs, and ad hoc safety analysis when required
• You will oversee safety related internal and external audits and safety related activities of inspection readiness

Leadership

• You will lead and manage experienced and motivated safety sciences and pharmacovigilance teams
• You will have Executive leadership skills to educate and influence stakeholders and to add value to strategic business planning and decision-making
• You will supervise employees through direct reporting, matrix, or in collaboration with external partners (CROs)
• You will identify procedural gaps and challenges and propose and implement solutions, leading the establishment of business process optimization efforts to ensure efficiency and process improvements with the department
• You will establish, measure, and report key compliance, quality, and performance indicators with cross functional stakeholders
• You will develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met
• You will perform all duties in keeping with the Company's core values, policies and all applicable regulations and procedures

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 

Experience:

• Qualified healthcare or drug development professional with relevant postgraduate qualification in medical/health sciences (e.g. MD, DO, MBBS, PharmD, PhD)
• Minimum 10 years of safety sciences and PV experience within the biotechnology/pharma industry, with a proven track record of leadership. Experience in oncology is required
• Minimum 5 years of leadership and people management in safety sciences and Pharmacovigilance
• Strong understanding of clinical development, regulatory submissions and labeling activities
• Deep and firm knowledge of ICH, FDA, EMA and other HAs guidelines
• Excellent background in Clinical Safety/Risk Management. Strong expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting
• Authoring and review of multiple periodic and ad hoc safety reports (more than 8 years of experienced required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries)
• Experience in writing multiple safety analysis, performing signal detection or safety.surveillance, risk management and preparing responses to Health Authorities
• Experience in negotiating with Health Authorities, filing and product labeling
• Excellent demonstrated leadership, strategic thinking, and communication skills

• Ability to work in a dynamic environment to meet corporate and patient needs
• Proven track record in leading and developing teams, global functions and working cross-functionally
• Excellent presentation, verbal and written communication, and collaboration skills
• Demonstrated success in taking the initiative in a team setting
• Comfortable with ambiguity yet be self-motivated and timeline driven
• Ability to work independently, establish priorities, and execute with minimal guidance
• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflict resolution, and effective partnership 
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
• Have impeccable professional ethics, integrity and judgment

Important Information

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