Senior Director, Clinical Science

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and 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 of January 2022, the Company has a global team of approximately 2000 employees.

Job Description

Reporting to the SVP, Global Clinical Development, the Senior Director Clinical Science drives the scientific rigor and integrity of our clinical research programs. This role involves development of clinical protocols to ensure clinical trials meet regulatory standards and include unbiased and well-controlled clinical design. The Senior Director will collaborate closely with cross-functional teams, including clinical operations, translational medicine, regulatory affairs, and medical affairs, to ensure the seamless execution of clinical trials that meet the highest standards of quality and compliance. The position will be based in our office in South San Francisco, CA.

• Develop and implement standards for clinical protocols, including data monitoring and preparation of clinical data to ensure consistency and quality.
• Lead strategic collaborations with colleagues across various departments to gather input and refine clinical protocols.
• Work closely with study physicians to analyze and interpret clinical trial data, ensuring accuracy and integrity in data reporting.
• Lead the creation, review, and submission of key clinical documents such as protocols, informed consent forms, clinical study reports, and regulatory submissions.
• Collaborate with regulatory affairs to support regulatory strategy development, submissions and interactions with health authorities.
• Work closely with other departments within R&D to align clinical science activities with broader company objectives, including business development diligence.
• Build and manage a team of clinical science professionals, fostering a culture of excellence and continuous learning.
• Engage with key stakeholders, including clinical investigators, key opinion leaders, patient advocacy groups, and academic institutions, to advance clinical research initiatives.
• Ensure compliance with all applicable regulatory standards and ethical guidelines in the conduct of clinical research.
• Work across several time zones and travel up to 30%.
   

Qualifications

REQUIRED:

• PhD in a relevant scientific discipline with 8 years of experience in clinical research within the biopharmaceutical industry; or equivalent combination of higher education, training and experience.

PREFERRED:

• Experience with global clinical trials and experience in all phases of drug development
• Proven track record of leading clinical science teams and successful execution of clinical trials and outcomes.
• Outstanding knowledge of industry issues and competitive landscape in drug development.
• Excellent leadership skills and the ability to manage and develop high-performing teams; strong collaboration and teamwork in cross-functional setting; comfortable with a hands-on leadership position.
• Excellent communication and collaboration skills to effectively interact with internal and external stakeholders.
   

Additional Information

The pay range for this position at commencement of employment is expected to be between $257K and $299K/year; however, base pay offered may vary depen