What are the responsibilities and job description for the Senior Director Clinical Science position at Zai Lab (US) LLC?
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 wellcontrolled clinical design. The Senior Director will collaborate closely with crossfunctional teams including clinical operations translational medicine regulatory affairs and medical affairs to ensure the seamless 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 :
PREFERRED :
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 depending on multiple individualized factors including market location jobrelated knowledge skills and experience. The total compensation package for this position may also include other elements including a signon 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 atwill 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.
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.
Remote Work : Employment Type :
Fulltime
Key Skills
Accounting Software,Access Control System,B2C,Banqueting,Jewellery,Linux Administration
Experience : years
Vacancy : 1
Salary : $257,000 - $299,000