Lead Counsel, China R&D

ROLE SUMMARY

• The attorney in this position will be responsible for providing and managing the R&D Legal team’s support for clinical development and general legal matters in China. The role serves as a key strategic partner to Development China leadership. The role has key accountability to recognize legal issues and advise on a broad range of clinical trial-related issues in China including negotiation of clinical research agreements and clinical trial execution matters. The role also includes advising on more general legal issues arising in the Development China group, including regulatory matters, human genetic resources related processes, quality events, oversight of CROs and other vendors.
• This role will manage two attorneys based in Shanghai and will report to the International Clinical Development Legal lead, R&D Legal, based in Cambridge, Massachusetts.

ROLE RESPONSIBILITIES

• Provide and manage regional legal support to Pfizer’s clinical development activities in China.
• Manage Shanghai-based legal team of two attorneys.
• Strategically partner with Development China leadership to support day-to-day operations, and serve as the legal representative on various leadership teams and committees; partner with other support lines such as Compliance to ensure compliance with applicable laws.
• Assist clients with preparation, communications and meetings with government / regulatory agencies as needed.
• Provide legal advice related to clinical development and operational issues including clinical trial conduct, informed consent, subject privacy, human genetic resources, research injury claims, quality issues, grants, clinical vendors and site performance matters (e.g., adverse events, inspections, sample collection, post-study drug access, article publications, and audits).
• Provide legal support for business transactions including site and vendor contracting, collaboration and sponsorship agreements and confidentiality agreements. Support Innovation Centers and strategic collaborations.
• Review of internal and external communications and presentations.

The attorney is expected to independently advise clients on day-to-day legal issues.  In addition, the attorney will have the ability to advise and influence across functions to ensure that legal issues are addressed.

Work collaboratively within the China-based legal teams and with other legal colleagues including those on the R&D Legal team, as well as colleagues in Pfizer China and other Pfizer affiliates.

Demonstrate strong organizational, interpersonal, influencing and communication skills in Mandarin Chinese and English.

Must have the highest integrity and work ethic, be detail-oriented and be able to prioritize and manage multiple assignments.

QUALIFICATIONS

Required:

• Licensed to practice law in China.
• Strong Mandarin Chinese and English language skills.
• At least 10 years’ experience as an attorney in private practice supporting biopharma companies, or in-house in the biotech and/or pharmaceutical industry.
• Significant and broad experience providing strategic guidance to senior business leaders similar to a general legal counselling role for an organization.
• Experience managing attorneys and triaging numerous types of requests for legal support.
• Excellent research, writing, negotiation, counselling, interpersonal and communication skills, and a client service orientation.
• Ability to work independently and to collaborate as a team member when needed, across the organization and with external counsel.
• Integrity and honesty, maturity, attention to detail, accountability, sound judgment, and the ability to prioritize and take ownership of issues and provide concise and timely advice.

Preferred:

• At least 12 years’ relevant experience as an attorney in the pharmaceutical or biotech industry or at a law firm supporting biopharma clients.
• Experience and working knowledge of clinical development issues including clinical trial conduct, informed consent, subject privacy, human genetic resources, research injury claims, quality issues, clinical vendors and site performance matters (e.g., adverse events, inspections, sample collection, post-study drug access, article publications, and audits).
• Experience and working knowledge of business transactions including site and vendor contracting, collaboration and sponsorship agreements, confidentiality agreements.
• Experience in interactions with governmental authorities.
• Experience managing outside counsel.
• Proven ability to cultivate strong client relationships, build credibility and successfully influence leadership in a fast-paced business climate.
• Culturally sensitiveand able to interact effectively with colleagues and clients from varied backgrounds.
• Demonstrated experience and success in managing and working within a complex matrixed environment.
• Graduate of a law program from an accredited university in China with a Chinese Bar Certification

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This role would require occasional travel within China and to Pfizer New York headquarters or other Pfizer offices and regulatory agency locations

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.