The Medical Director will support the clinical development of oncology programs focusing on the design execution and oversight of clinical trials. Responsibilities include independently contributing to and executing on the clinical strategy serving as Medical Monitor supporting regulatory submissions and collaborating and leading cross-functional teams. The role provides scientific and medical input to ensure the successful conduct of clinical trials and advancement of oncology assets.
This role reports to the VP Clinical Development Oncology and is based in our Cambridge MA office.
- Clinical Trial: Provide medical expertise to support the leading physician/scientist for the design and execution of oncology clinical trials. Collaborate 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 assigned clinical trials ensuring patient safety protocol compliance and medical oversight. Review safety data participate in data monitoring activities and act as the primary medical contact for study teams and investigators.
- Cross-functional Collaboration: Work with regulatory affairs clinical operations pharmacovigilance biostatistics. medical affairs and commercial teams to align clinical and business objectives often across multiple time zones.
- 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.
- Regulatory Support: Support the preparation of regulatory documents participate in health authority interactions and contribute to risk management planning and mitigation strategies throughout the development lifecycle.
- Business Development Support: Support medical leadership team to to support licensing opportunities partnerships and due diligence activities.
- Scientific Support: Maintain up-to-date knowledge of oncology trends the competitive landscape and regulatory changes to inform clinical strategy and contribute to clinical development function.
Qualifications :
REQUIRED
- MD with board certification in Oncology Hematology-Oncology or a related specialty
PREFERRED
- Clinical development experience with a focus on late-stage trials preferably as a Medical Monitor
- Experience in cross-functional team environments
- Understanding of oncology drug development clinical endpoints and regulatory pathways.
- Clinical practice experience or experience as an investigator
- Strong communication skills.
- Effective collaboration skills to effectively interact with internal and external stakeholders.
- High ethical standards and commitment to scientific rigor.
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 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. 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 :
No
Employment Type :
Full-time
The Medical Director will support the clinical development of oncology programs focusing on the design execution and oversight of clinical trials. Responsibilities include independently contributing to and executing on the clinical strategy serving as Medical Monitor supporting regulatory submission...
The Medical Director will support the clinical development of oncology programs focusing on the design execution and oversight of clinical trials. Responsibilities include independently contributing to and executing on the clinical strategy serving as Medical Monitor supporting regulatory submissions and collaborating and leading cross-functional teams. The role provides scientific and medical input to ensure the successful conduct of clinical trials and advancement of oncology assets.
This role reports to the VP Clinical Development Oncology and is based in our Cambridge MA office.
- Clinical Trial: Provide medical expertise to support the leading physician/scientist for the design and execution of oncology clinical trials. Collaborate 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 assigned clinical trials ensuring patient safety protocol compliance and medical oversight. Review safety data participate in data monitoring activities and act as the primary medical contact for study teams and investigators.
- Cross-functional Collaboration: Work with regulatory affairs clinical operations pharmacovigilance biostatistics. medical affairs and commercial teams to align clinical and business objectives often across multiple time zones.
- 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.
- Regulatory Support: Support the preparation of regulatory documents participate in health authority interactions and contribute to risk management planning and mitigation strategies throughout the development lifecycle.
- Business Development Support: Support medical leadership team to to support licensing opportunities partnerships and due diligence activities.
- Scientific Support: Maintain up-to-date knowledge of oncology trends the competitive landscape and regulatory changes to inform clinical strategy and contribute to clinical development function.
Qualifications :
REQUIRED
- MD with board certification in Oncology Hematology-Oncology or a related specialty
PREFERRED
- Clinical development experience with a focus on late-stage trials preferably as a Medical Monitor
- Experience in cross-functional team environments
- Understanding of oncology drug development clinical endpoints and regulatory pathways.
- Clinical practice experience or experience as an investigator
- Strong communication skills.
- Effective collaboration skills to effectively interact with internal and external stakeholders.
- High ethical standards and commitment to scientific rigor.
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 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. 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 :
No
Employment Type :
Full-time
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