Senior Director / Vice President, Legal
The Senior Director / Vice President, Legal will be responsible for coordinating all legal activities for the Company. The Senior Director / VP Legal will be a collaborative “doer” with sound experience in the biotechnology and pharmaceutical industry. In addition to providing legal direction, the Senior Director / VP Legal will bring sound business judgment to areas such as business development opportunities, licensing agreements, clinical contracts, and support of planned IPO. The ideal candidate may currently be in a #2 or #3 legal role for a mid-size or large pharmaceutical company. The Senior Director / Vice President, Legal will report to the Chief Financial Officer.
Primary Duties and Responsibilities
- Manage all legal matters, including determining work to be performed in-house or through outside counsel to optimize legal activities and minimize risk
- Draft, negotiate, and bring to execution clinical vendor agreements critical to the company's global clinical development operations.
- Assist Business Development team in negotiating terms and conditions.
- Advise and assist in drafting of business development transactions and inter-company agreements.
- Support capital raising and IPO, as needed
- Oversee Company’s IP portfolio
- Work with IP counsel to prepare and prosecute global patent applications relating to all aspects of therapeutic molecules, including pharmaceutical compositions, formulations, methods of treatment, administration regimens, biomarkers, and diagnostics
- Conduct patent landscape overviews, freedom-to-operate analyses, validity assessments and patentability assessments
- Identify and capture new inventions relating to current assets
- Develop and monitor various company compliance programs including R&D, regulatory affairs and FCPA etc.
- Review company press releases, announcements, and publications
- Formalize company templates e.g. CDAs, NDAs, MSAs etc.
- Provide legal support for a wide variety of business transactions, including clinical trial agreements, ancillary service agreements, registry and observational study agreements, clinical experimental sciences agreements, clinical vendor agreements, site management organization agreements, research collaboration agreements, investigator-initiated agreements, consulting agreements and confidentiality agreements.
- JD and licensed to practice law in California.
- At least 12 years of legal experience, including in-house biotech or pharmaceutical experience
- Experience with clinical contracts related to clinical development of biologics and/or pharmaceuticals.
- Experience with contracts involving intellectual property.
- High level of business acumen.
- Excellent contract drafting and negotiation skills.
- Exceptional oral and written communication skills.
- Ability to work independently, while meeting aggressive deadlines and juggling multiple matters.
- Ability to work effectively with senior management as well as other employees in Clinical Operations, Discovery, CMC, and Translational Medicine
- Mandarin a plus; not required.