Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Opportunity
Denali Therapeutics is recruiting an experienced Senior Director, Healthcare Law and Compliance, reporting to the General Counsel. We have built a diverse Legal team that is fully integrated across Denali’s business, and we need your help to create a healthcare law and compliance practice. The position will support teams working to build Denali’s commercial readiness, including regulatory, medical affairs, patient advocacy, market access and pricing, government price reporting, marketing, sales, and manufacturing. There are many rewarding opportunities for a growth-minded, experienced attorney to make a significant impact by creating Denali’s healthcare law and compliance program and ultimately helping patients suffering from neurodegenerative diseases.
Responsibilities
- Build commercial readiness across Denali by applying solution-oriented legal and business expertise to regulatory, medical affairs, clinical development, manufacturing, market access, and commercial teams to enable a successful product launch;
- Provide innovative, solution-oriented advice to Denali’s leadership to support effective compliance and risk management throughout the company on healthcare laws impacting the commercialization of Denali’s products.
- Act as the Legal lead on healthcare-related strategic transactions, including market access-related contracting such as contracts with wholesalers/specialty distributors, pharmacies, PBMs, payers, and patient support/hub vendors.
- Partner with the Contracts team to advise Denali on building and maintaining effective, compliant, and transparent relationships with healthcare professionals and clinics, patients, advocacy organizations and societies, and government entities.
- Partner across Legal and Denali to advise on privacy laws and data use and build an effective privacy compliance program.
- Serve as a compliance steward for Denali, helping to inculcate and foster a culture of compliance among employees in their daily work.
- Advise Denali leadership on creating and implementing an effective healthcare compliance program, including by creating strategy, drafting and implementing healthcare compliance policies, practices, trainings, and audits/investigations/monitoring, and collaborating across the Legal team to implement the program.
- Continue developing your legal skills to keep up to date with, and advise Denali leadership on, the evolving healthcare law and compliance landscape and current enforcement trends, and develop your information technology skills to experiment with and incorporate technology solutions to Denali’s healthcare law related compliance program.
- Participate on the Legal Leadership team to build an effective, diverse, and collegial Legal team;
- Develop your external legal network to build and manage relationships with outside counsel across healthcare law and compliance to ensure efficient and optimal outcomes for Denali’s legal matters.
Who You Are
- Juris Doctor (ABA accredited school), and active membership in a state bar (CA preferred) and in good standing
- At least 10 years of experience practicing as a licensed attorney, with in-house corporate legal experience required, and both law firm and in-house experience preferred
- Deep substantive experience and expertise in biotechnology company-relevant areas of healthcare law, including Federal and state fraud & abuse laws, FDA regulatory law, regulation and guidance, product liability, pricing, government price reporting and market access-related laws, and ability to identify risks in areas such as privacy/data protection law, antitrust law, and other laws and regulations related to the development, and manufacturing and commercialization of biotechnology products
- Previous experience providing legal advice related to launching a product is preferred
- A track record of shaping a corporate culture in which compliance is a key objective in business decision-making and processes and is aligned with a company’s values.
- Impeccable judgment and able to build credibility and trust by acting ethically and with integrity
- Thrive in providing creative, solution-oriented legal advice, being a flexible team player, and having a growth mindset
- Strong interpersonal and excellent verbal and written communication skills, with ability to communicate with poise and tact, and motivated to communicate strategy to all levels of the company
- Ability to make an impact as an individual contributor, and the experience managing attorneys and compliance professionals and building and leading cross-functional teams to have a leadership impact when the need arises
Salary Range: $265,000.00 to $325,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
