As a senior member of the legal and compliance team, this position will help lead the healthcare compliance efforts at Dynavax. The position will be based in Emeryville, California at corporate headquarters.
- Provide day-to-day leadership of global healthcare compliance program.
- Evaluate and assess commercial and medical affairs activities with respect to current laws, regulations, enforcement environment, and best practices related to the development, marketing, and sale of vaccines.
- Oversee strategy and assist with enhancing and continuous improvement of a best in practice Compliance Program.
- Develop, draft, and carry out compliance policies and procedures.
- Lead and develop training and communication plans; conduct periodic training.
- Implement and carryout periodic monitoring and audit plans to assess and evaluate key metrics on compliance with policies and procedures.
- Provide compliance support across the organization working with colleagues in commercial, medical affairs, clinical, regulatory, finance, and other departments to complement existing compliance activities, 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 and compliance department.
- Manage outside consultants.
- 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.
- Minimum of 8-10 years of compliance experience, preferably in the biopharmaceutical or medical device industry; experience leading a compliance team or department a plus.
- Advanced degree (Masters or Juris Doctorate) preferred, or equivalent experience.
- Strong knowledge of compliance requirements in a highly regulated industry, and an ability to apply them in a way that is reflective of the business need but also ensures compliant business conduct.
- Must be an analytical and strategic thinker with an ability to interpret laws, regulations, and industry guidelines and conceptualize policies and procedures.
- Ability to lead as well as collaborate, and function well in a fast-paced 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.