Head of Clinical Pharmacology

Primary Function:

Zai Lab is seeking an experienced Clinical Pharmacology leader to lead the Clinical Pharmacology function and serve as a key member of the Development Leadership Team. This role is responsible for clinical pharmacology strategy model-informed drug development and regulatory support across Zai Labs portfolio supporting global development of small molecules biologics and other innovative therapeutics.

This role is based in our South San Francisco CA office.

Major Responsibilities and Duties:

• Provide strategic leadership for the Clinical Pharmacology function including clinical pharmacology modeling and simulation and bioanalytical activities across Zai Labs portfolio.
• Develop and implement clinical pharmacology strategies to support global development and registration of small molecules biologics and other innovative therapeutics.
• Serve as the clinical pharmacology lead for development programs and contribute to key development regulatory and portfolio decisions.
• Lead clinical pharmacology assessments and quantitative analyses including PK/PD exposure-response evaluation modeling and simulation and human dose projection to support development and regulatory strategies.
• Partner closely with Clinical Development Translational Sciences DMPK Regulatory Affairs Biometrics and other cross-functional teams to ensure effective integration of clinical pharmacology into development plans.
• Oversee the quality execution interpretation and reporting of clinical pharmacology activities conducted internally and through CROs alliance partners and external collaborators.
• Lead the preparation of clinical pharmacology components of regulatory submissions and regulatory interactions including INDs CTAs protocols IBs briefing documents and responses to health authority inquiries.
• Evaluate and implement appropriate clinical pharmacology bioanalytical and quantitative science technologies and capabilities to support portfolio needs.
• Build and develop a high-performing Clinical Pharmacology organization through talent development succession planning and capability building.
• Provide clinical pharmacology leadership for business development evaluations due diligence activities and external collaborations.

Qualifications :

Required:

• PhD in Clinical Pharmacology Pharmacokinetics Drug Metabolism Pharmaceutical Sciences or a related field with 12 years relevant experience in drug development including industry regulatory or other related settings; or equivalent combination of higher education training and experience.

Preferred:

• Demonstrated leadership in clinical pharmacology and drug development.
• Demonstrated knowledge of clinical pharmacology non-clinical packages and regulatory requirements supporting global drug development including first-in-human studies dose justification registration programs and post-approval commitments. Strong knowledge of GLP GCP ICH and relevant global regulatory guidelines is required.
• Demonstrated experience applying model-informed drug development approaches including population PK exposure-response analyses PBPK and other quantitative methods to support development and regulatory decision-making.
• Experience leading clinical pharmacology contributions to regulatory submissions and interactions with global health authorities including FDA EMA CDE and other regulatory agencies.
• Experience managing external partners CROs and vendors supporting clinical pharmacology bioanalytical and modeling activities. Strong communication and influencing skills with the ability to work effectively across cross-functional teams and senior leadership.
• Proven leadership experience in building and developing high-performing teams driving organizational capability and leading cross-functional collaboration in a matrix environment.
• Experience supporting business development evaluations due diligence activities and external collaborations is preferred.
• Experience in biotech and cross-regional collaboration with Asia/China.
• Must have the highest personal values and ethical standards.

Additional Information :

The pay range for this position at commencement of employment is expected to be between $283k and $411K/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. Thats 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.

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Remote Work :

No

Employment Type :

Full-time