Senior Director, R&D Compliance

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused, innovative, commercial-stage, global biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing, and commercializing our portfolio in order to impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharma companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our extensive track record of execution and delivering results, 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.  Through these partnerships, Zai Lab has built the strongest late stage oncology portfolio with global first-in-class and/or best-in-class profile, among innovative Chinese biotech companies. We are further supplementing our pipeline with an in-house discovery effort aiming to produce 1-2 global INDs per year.

Zai Lab is rapidly expanding into a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing innovative medicines. To that end, we have built our internal R&D center to advance our discovery pipeline, a strong clinical development and operations team, and our own manufacturing facilities in China. We have also established a highly specialized commercial team to support marketing of our innovative products in China. We believe this integrated approach will provide sustainable competitive advantages for Zai Lab.

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. Zai Lab significantly expanded with several offices across China and U.S. and opened its U.S. Research Operations in San Francisco in December 2018. And in September of 2021 we opened our Cambridge, MA office. As of January 2022, the Company has a global team of over 1900 employees.

Job Description

The Senior Director will be the primary global ethics and compliance touchpoint for the Zai R&D organization.  This would include developing relevant global standards applicable across the geographies in which the company operates, coordinating with local compliance teams to ensure seamless adaption and adoption of the global standards within their country organizations, providing guidance and updates to R&D senior management as to compliance program topics relevant to their functions, and connect regularly with the other global ethics and compliance members to assure program alignment across the company.
•    Drafting R&D relevant global policies, procedures or other formal guidance documents under the ethics and compliance department’s remit
•    Developing and deploying training on such relevant written standards, either through the company Learning Management System or through other channels such as town hall meetings, functional events or R&D leadership meetings
•    Providing ongoing advising as to risk management within the global R&D organization
•    Developing and monitoring plans based on risk prioritization with the R&D organization and ensure execution at the global functional and local level
•    Participating in global risk management activities and governance structures as warranted
•    Supporting the global ethics and compliance function in designing and implementing systems relevant to R&D activities
•    Supporting the global ethics and compliance function as part of the functional management team.

This position is primarily located in the San Francisco area with the possibility of working remotely consistent with Company policies.

Qualifications

•    7-10 years of experience in biotech or pharma multinational companies with 3-5 years specifically on Compliance matters, with deep understanding of the R&D operations of bio/pharma companies.
•    Be professional and proficient in bringing insights on managing risk from a risk identification perspective as well as advising on, and building, appropriate and effective systems of controls.
•    Be able to provide pragmatic solutions to business and cross-functional teams.
•    Self-motivated, ability to work independently under pressure and prioritize multiple projects, and work effectively in a fast-paced, result-oriented environment.
•    Good team player with good interpersonal skills and ability to interact with different levels of people throughout the company
•    Good networking to leverage resources inside and outside to provide on-time and quality service.
•    Familiarity with MS Office
•    Some national and international travel may be required (approximately 30% or less).

Zai Lab US requires all employees who are working onsite or who are in customer facing positions to be vaccinated against COVID-19 (subject to any legally required exemptions)

Additional Information

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.