What are the responsibilities and job description for the Vice President, Pharmacovigilance and Safety Sciences position at Tbwa Chiat/Day Inc?

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 www.olema.com.

About the Role >

Vice President, Safety Sciences and Pharmacovigilance

As the Vice President of Pharmacovigilance and Safety Sciences, you are responsible for overseeing the safety of all of Olema’s drug products. You will be responsible for the company’s strategy and execution of safety sciences and pharmacovigilance for early and late phase clinical programs. You will work cross-functionally and will manage experienced and high performing safety sciences and pharmacovigilance teams.

You must be passionate about working on cutting edge research and developing advanced analytics solutions in the field of safety sciences and pharmacovigilance.

This role is based out of our San Francisco, CA office hub.

Your work will primarily encompass activities in safety sciences, risk management, pharmacovigilance and functional and cross-functional leadership.

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 knowledge , experience , and attributes for this role.

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 experience 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.

Attributes :

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.

The base pay range for this position is expected to be $325,000-365,000 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.

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.

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Salary : $325,000 - $365,000

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Vice President, Pharmacovigilance and Safety Sciences

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