Director, Pharmacovigilance/Safety Scientist

Zai Lab (US) LLC; South San Francisco (CA); Presencial; USD 221.000 - 310.000; Jornada completa

Descripción de la vacante

Zai Lab Limited is seeking a Director, Pharmacovigilance/Safety Scientist to lead scientific safety evaluation across Oncology and NSI products, spanning development to post-marketing. You will collaborate with Safety Physicians, drive global safety strategies, and ensure regulatory compliance with ICH/GVP standards.

The role requires deep experience in pharmacovigilance, signal detection, and safety document leadership, along with strong writing and communication skills to interact with

Formación

• BS in health-related scientific discipline with 12 years relevant pharmaceutical or biotech industry experience, of which 8 years are within pharmacovigilance / drug safety.
• Advanced degree preferred.
• Experience in Oncology, Neuroscience and/or Immunology strongly preferred.
• Demonstrated expertise in signal detection and evaluation, benefit–risk and causality assessment, and authoring global regulatory safety documents.

Responsabilidades

• Provide scientific and operational leadership for safety evaluation and risk management across Oncology and NSI portfolios.
• Lead global safety strategies and contribute to regulatory compliance; inform safety governance bodies.
• Perform signal detection and evaluation, review literature, and manage safety documentation (DSURs, PBRERs/PSURs, RMPs, REMS).
• Represent safety in governance forums, senior leadership, and cross-functional teams; travel up to 10%.

Conocimientos

Signal detection

Benefit risk assessment

Causality assessment

Regulatory writing

Leadership

Safety governance

Executive communication

Educación

BS in health-related science

Advanced degree preferred

Descripción del empleo

Director, Pharmacovigilance/Safety Scientist

• Full-time

Zai Lab Limited(NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based inChinaandthe United Statesfocused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients inChinaand around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts. As ofJanuary 2022, the Company has a global team of approximately 2000 employees.

Primary Function:

The Director, Pharmacovigilance/Safety Scientist provides scientific and operational expertise for the safety evaluation and risk management of products within the Oncology and Neuroscience & Immunology (NSI) portfolios across the full product lifecycle, including clinical development and post‑marketing.

This role partners closely with Safety Physicians and cross-functional stakeholders to execute global safety strategies, support regulatory compliance, and contribute to scientifically sound benefit–risk decision‑making to protect patients. The Director works hands‑on in core pharmacovigilance activities, including signal detection and evaluation, authoring key regulatory safety documents, inspection readiness, and managing regulatory requests, in close collaboration with Safety Physicians on matters requiring clinical and medical judgment. The role represents Pharmacovigilance in governance forums and senior leadership discussions.

This position is based in our South San Francisco, CA office.

Major Responsibilities and Duties:

Safety Strategy & Scientific Leadership

• Collaborate with safety physicians to lead the global safety evaluation and risk management strategy for assigned Oncology and NSI products across development and post marketing stages.

Provide expert scientific judgment in collaboration with safety physicians in benefit–risk assessment, causality assessment, signal detection and evaluation, and risk minimization

• Anticipate, identify, and proactively manage complex and emerging safety issues.
• Collaborate with safety physicians to elevate safety issues appropriately to senior management and safety governance bodies, with clear, evidence based scientific recommendations.

Pharmacovigilance Operations & Oversight

• Collaborate with safety physicians in performing signal detection and evaluation activities, including review of aggregated safety data, literature surveillance, real‑world evidence, and maintenance of signal tracking documentation.
• Lead the planning, coordination, and preparation of key regulatory safety documents, including Development Safety Update Reports（DSURs）, Periodic Benefit‑Risk Evaluation Reports （PBRERs/PSURs）, EU Risk Management Plans （RMPs）, US Risk Evaluation and Mitigation Strategies （REMS） documents or relevant components, health authority responses, and ad hoc safety assessments.
• Ensure all safety documentation is scientifically sound, inspection‑ready, and compliant with global regulatory requirements (e.g., ICH, GVP, FDA, EMA).
• Oversee pharmacovigilance vendor activities and deliverables, ensuring compliant, high‑quality execution of outsourced safety operations.

Governance, Communication & Influence

• Manage safety governance committee operations.
• Collaborate with safety physicians to represent safety on cross‑functional governance bodies, Safety Review Teams, and Product or Development Teams.
• Support pharmacovigilance training and education for internal and external stakeholders.
• Present safety data, emerging risks, and strategic recommendations to senior leadership and governance committees.
• Provide evidence‑based information and collaborate with safety physicians to make safety‑related decisions, balancing patient safety, regulatory expectations, and program objectives.
• Collaborate across several time zones and travel up to 10%.

External Representation & Inspection Readiness

• Represent the organization during regulatory authority interactions, audits, and inspections related to pharmacovigilance activities.
• Interact with external expert consultants regarding safety issues and policies.
• Maintain awareness of the evolving global pharmacovigilance and regulatory landscape, particularly as it relates to oncology and immunology therapies, and translate changes into actionable safety strategies.

REQUIRED:

• BS in health‑related scientific discipline with 12 years relevant pharmaceutical or biotech industry experience of which 8 years are within pharmacovigilance / drug safety; or equivalent combination of higher education, training and experience.

PREFERRED:

• Advanced degree preferred.
• Experience in Oncology, Neuroscience and/or Immunology strongly preferred.
• Demonstrated expertise in signal detection and evaluation, benefit–risk and causality assessment, and authoring global regulatory safety documents.
• Strong knowledge of global pharmacovigilance regulations and methodologies (e.g., ICH, GVP, FDA, EMA).
• Proven ability to lead and influence within a complex, global matrix organization.
• Excellent scientific writing, communication, and presentation skills, including engagement with executive leadership.
• Working knowledge of pharmacoepidemiology, statistics, or real‑world evidence.
• Demonstrated strategic thinking, sound judgment under pressure, and comfort managing ambiguity.
• Resilient and adaptable, with a strong commitment to patient safety, regulatory compliance, and continuous improvement.
• Maintains the highest standards of integrity, ethics, and professional conduct.

The pay range for this position at commencement of employment is expected to be between $221K and $310K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign‑on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

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