Dynavax Technologies

Associate General Counsel

Location
Berkeley, CA, US
Posted
Feb 13, 2019
Ref
19-009R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Overview

As a senior member of the legal team, this position will advise Dynavax management and employees with respect to a broad variety of business and legal matters, including regulatory and compliance, product promotion, Medical Affairs activities, clinical trials and contracting. The position will be based in Berkeley, California at corporate headquarters.

Responsibilities

  • Provide day-to-day legal services and strategic input to the company on a broad variety of issues.
  • Advise all Dynavax organizations on regulatory, compliance, product promotion, Medical Affairs, clinical trial and contracting. This would include regulatory, commercial, research and development, discovery, medical affairs and other functions.
  • Assist with enhancing and continuous improvement of a best in practice Compliance Program.
  • Serve as lead counsel on company's cross-functional Heplisav-B Brand Team.
  • Broad responsibilities also will include helping negotiate and draft contracts and agreements related to research, development and clinical studies.
  • Function independently as primary reviewer and advisor regarding consulting and vendor contracts and agreements to ensure terms and conditions are in compliance with local, state, and federal regulations, and safeguard the company's interests.
  • Provide legal support across the organization, including identifying practical solutions that balance the risk/benefit for the company.
  • Assist with developing, implementing, and improving processes and systems to increase the efficiency of the legal department.
  • Work with General Counsel to support the business in other substantive areas, as needed.
  • Manage outside counsel.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.


Qualifications

  • JD, admission to the California bar, or admission to another state bar and eligible for California In-House Counsel license, and at least 10 years of regulatory and/or compliance experience in the biopharmaceutical or medical device industry, as in-house counsel and/or with a law firm.
  • Experience as an attorney with a prominent law firm.
  • Strong knowledge of regulatory and/or compliance requirements and an ability to apply them in a way that is reflective of the business need but also ensures compliant activities.
  • Must be a strategic thinker.
  • Ability to research laws and industry standards.
  • Ability to lead as well as collaborate, and function well in a team environment.
  • Demonstrated experience with effectively managing multiple projects/priorities.
  • Ability to work effectively with, influence and get consensus across functional units and at all levels in the organization as well with external parties.
  • Proven ability to make sound judgments and decisions. Able to quickly assess problems/situations and provide effective resolutions/solutions.
  • A "can do" professional who will work proactively with both internal and external resources to drive results.
  • Excellent interpersonal skills and the ability to build and maintain positive work relationships and effectively interface across the organization.
  • Excellent communicator - both verbal and written - with business acumen and the ability to consistently meet or exceed project deadlines.
  • Flexible, high level of integrity, action and goal-oriented.


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