Zai Lab (US) LLC
Senior Medical Director, Oncology Clinical Development (Office Based - Cambridge
Zai Lab (US) LLC, Cambridge, Massachusetts, us, 02140
Company Description
Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide. Zai Lab's global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it's needed most. Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors. In China, we've earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine. Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth. Job Description
The Senior Medical Director will lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration studies. Responsibilities include independently contributing to and executing on the clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization efforts, and collaborating and leading cross-functional teams. The role plays a key part in scientific oversight to ensure successful execution and advancement of oncology assets and representing Zai Lab externally. This role is based in our Cambridge, MA office. Clinical Trial Leadership:
Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies. Collaborate closely with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements. Medical Monitoring:
Serve as Medical Monitor for Phase III and registration trials, ensuring patient safety, protocol compliance, and timely medical oversight. Review safety data, support data monitoring activities, and act as the primary medical contact for study teams and investigators. Strategic Input:
Contribute expert medical and scientific leadership to clinical development strategies, regulatory submissions, and lifecycle planning. Cross-functional Collaboration:
Work closely with regulatory affairs, clinical operations, pharmacovigilance, biostatistics, medical affairs, and commercial teams to align clinical and business objectives. External Representation:
Represent Zai Lab in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators. Data Analysis & Interpretation:
Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Collaborate with cross-functional teams to translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement. Lifecycle Management:
Develop strategies for label expansion, post-marketing commitments, and long-term product differentiation. Regulatory Support:
Lead the preparation of regulatory documents, participate in health authority interactions globally, and contribute to risk management planning and mitigation strategies throughout the development lifecycle. Business Development:
Provide clinical expertise to support licensing opportunities, partnerships, and due diligence activities. Stakeholder Engagement:
Build strong relationships, challenge ideas constructively, and drive impactful decision-making based on scientific evidence. Scientific Leadership:
Maintain up-to-date knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy. Qualifications
REQUIRED MD with board certification in Oncology, Hematology-Oncology, or a related specialty, and five years of clinical development experience, with a focus on late-stage oncology trials. Ability to work across several time zones and travel up to 30%. PREFERRED Proven track record as a Medical Monitor for pivotal trials and successful regulatory submissions. Deep understanding of oncology drug development, clinical endpoints, and regulatory pathways. Proven ability to lead cross-functional teams and manage complex clinical programs. Clinical practice experience or experience as an investigator is a plus. Excellent leadership, strategic thinking, and communication skills. Strong collaboration skills to effectively interact with internal and external stakeholders. Demonstrated commitment to high personal values and ethical standards. Additional Information
The pay range for this position at commencement of employment is expected to be between $299K and $332K/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 Lab, 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, 59% of our employees are women and 53% 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. #J-18808-Ljbffr
Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide. Zai Lab's global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it's needed most. Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors. In China, we've earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine. Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth. Job Description
The Senior Medical Director will lead late-stage clinical development programs in Oncology, including pivotal Phase III trials and registration studies. Responsibilities include independently contributing to and executing on the clinical strategy, serving as Medical Monitor, supporting regulatory submissions and commercialization efforts, and collaborating and leading cross-functional teams. The role plays a key part in scientific oversight to ensure successful execution and advancement of oncology assets and representing Zai Lab externally. This role is based in our Cambridge, MA office. Clinical Trial Leadership:
Provide medical leadership for the design and execution of late-stage clinical trials, including pivotal and confirmatory studies. Collaborate closely with clinical operations to ensure trials are conducted in alignment with scientific objectives, patient safety standards, and regulatory requirements. Medical Monitoring:
Serve as Medical Monitor for Phase III and registration trials, ensuring patient safety, protocol compliance, and timely medical oversight. Review safety data, support data monitoring activities, and act as the primary medical contact for study teams and investigators. Strategic Input:
Contribute expert medical and scientific leadership to clinical development strategies, regulatory submissions, and lifecycle planning. Cross-functional Collaboration:
Work closely with regulatory affairs, clinical operations, pharmacovigilance, biostatistics, medical affairs, and commercial teams to align clinical and business objectives. External Representation:
Represent Zai Lab in interactions with investigators, key opinion leaders, regulatory authorities, and external collaborators. Data Analysis & Interpretation:
Analyze clinical trial data and real-world evidence to identify trends, assess efficacy and safety signals, and support data-driven decision-making. Collaborate with cross-functional teams to translate findings into actionable insights that inform clinical strategy, regulatory submissions, and program advancement. Lifecycle Management:
Develop strategies for label expansion, post-marketing commitments, and long-term product differentiation. Regulatory Support:
Lead the preparation of regulatory documents, participate in health authority interactions globally, and contribute to risk management planning and mitigation strategies throughout the development lifecycle. Business Development:
Provide clinical expertise to support licensing opportunities, partnerships, and due diligence activities. Stakeholder Engagement:
Build strong relationships, challenge ideas constructively, and drive impactful decision-making based on scientific evidence. Scientific Leadership:
Maintain up-to-date knowledge of oncology trends, the competitive landscape, and regulatory changes to inform clinical strategy. Qualifications
REQUIRED MD with board certification in Oncology, Hematology-Oncology, or a related specialty, and five years of clinical development experience, with a focus on late-stage oncology trials. Ability to work across several time zones and travel up to 30%. PREFERRED Proven track record as a Medical Monitor for pivotal trials and successful regulatory submissions. Deep understanding of oncology drug development, clinical endpoints, and regulatory pathways. Proven ability to lead cross-functional teams and manage complex clinical programs. Clinical practice experience or experience as an investigator is a plus. Excellent leadership, strategic thinking, and communication skills. Strong collaboration skills to effectively interact with internal and external stakeholders. Demonstrated commitment to high personal values and ethical standards. Additional Information
The pay range for this position at commencement of employment is expected to be between $299K and $332K/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 Lab, 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, 59% of our employees are women and 53% 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. #J-18808-Ljbffr