Vice President Clinical Development Oncology
Vice President Clinical Development Oncology
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Salary Not Disclosed
1 Vacancy
Job Description
The Vice President Clinical Development Oncology will primarily lead the crossfunctional Zai Product Team setting team goals balancing cost time and quality developing risk mitigation strategies and troubleshooting issues. Reporting to the SVP Global Clinical Development Oncology this pivotal role involves strategizing clinical development ensuring regulatory compliance and driving innovative oncology development strategy. Leading a team of physicians the Vice President will formulate strategy design execute monitor and interpret multiple studies ensuring clinical data meets global regulatory standards. This role will also represent the program at health authority interactions create publications and drive process improvements among other business needs such as diligence for business development. This role is based in the South San Francisco CA office.
- Leadership and Expertise: Provide strategic leadership and clinical expertise in global oncology clinical research and drug development throughout the entire lifecycle. Establish team vision and goals that align with oncology leadership and product strategy. Lead and mentor a team of medical directors and crossfunctional professionals to achieve these objectives.
- Clinical Development and Study Design: Responsible for the clinical development plan including appropriate clinical trial designs to support and inform the target product profile. Design deliver and interpret clinical studies ensuring ethical and scientific integrity meeting regulatory requirements and compliance with international standards and company policies such as GCP and ICH guidelines
- Regulatory Compliance: Understand and support regulatory compliance in all relevant jurisdictions including but not limited to US EU UK and China.
- Operational Management: Oversee the operational aspects of clinical trials including budget management resource allocation and timeline adherence.
- CrossFunctional Collaboration: Lead and support colleagues necessary to drive the development program including but not limited to discovery and preclinical research (DMPK toxicology etc) clinical pharmacology clinical operations regulatory affairs translational medicine manufacturing pharmacovigilance and clinical quality to ensure successful of the clinical development plan.
- Stakeholder Engagement: Develop and maintain excellent relationships with external investigators and key opinion leaders and drive meaningful engagement and information exchange. Represent the company and deliver highest quality clinical information to regulatory authorities ethics committees and investigators/sites providing clarifications and solving medical issues.
- Innovation and Research: Drive innovation in oncology research integrating the latest scientific advancements into the companys programs. Provide strategic clinical and scientific knowledge into development decision points and target labeling integrating insights from literature advisory boards and competitive landscape.
- Scientific Inquiry and Knowledge Maintenance: Proactively drive scientific questions and ideas that support clinical hypothesis generation and life cycle management opportunities generating value for the asset. Maintain uptodate knowledge of relevant scientific literature and clearly communicate key impactful information.
- Business Development: Participate in business development activities to support the companys growth and expansion.
Qualifications :
REQUIRED
- MD with 12 years clinical oncology research experience with track record of development strategy protocol and study report writing successful of strategy in the US and global regions especially in Asia and EU.
- Work across several time zones and travel up to 30.
PREFERRED
- Proven experience in study design protocol development monitoring and implementing clinical trials with demonstrated strategic influence on clinical studies/programs.
- Indepth understanding of regulatory requirements and guidelines for oncology drug development.
- Excellent communication and interpersonal skills with the ability to engage effectively with internal and external stakeholders.
- Ability to form and maintain excellent relationships outside the company interact with regulatory agencies and demonstrate high credibility in scientific clinical and drug development competency.
- Knowledge of emerging trends and technologies in oncology research.
- Exceptional analytical and problemsolving skills.
- Strong leadership skills with the ability to manage and develop highperforming teams.
- Outstanding collaboration and teamwork in a crossfunctional setting; comfortable with a handson leadership position.
- Must have the highest personal values and ethical standards.
Additional Information :
The pay range for this position at commencement of employment is expected to be between $376K and $439K/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 :
No
Employment Type :
Fulltime
Employment Type
Full-time
