Director, Commercial & Medical Legal Counsel

3 weeks, 1 day ago
Full-time
Senior
Legal
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019

Description

  • Provide day-to-day legal counsel to Sales, Marketing, Market Access, Medical Affairs, HEOR, and Patient Advocacy teams on regulatory matters.
  • Advise on labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
  • Participate as a core member of promotional and medical MLR Review Committees.
  • Advise on interactions with healthcare professionals, payers, patients, and patient advocacy organizations to identify and mitigate compliance risks.
  • Review and draft contracts to ensure compliance with relevant regulatory standards.
  • Ensure compliance with applicable laws, regulations, policies, procedures, and controls across supported business areas.
  • Develop and deliver training for business partners on legal and compliance issues.
  • Communicate legal advice to business stakeholders in a clear and understandable way.

Requirements

  • Juris Doctorate and admission to practice law in at least one state.
  • Minimum 5 years of legal experience, including experience advising pharmaceutical or other life sciences clients.
  • In-house pharmaceutical industry experience is preferred.
  • Understanding of FDA promotional guidance, the Anti-Kickback Statute, the False Claims Act, the PhRMA Code, and relevant HHS-OIG guidance.
  • Strong interpersonal skills and ability to present complex information accurately and concisely to influence stakeholders at all levels of management.
  • Experience with state price reporting, transparency reporting, or privacy matters is preferred.
  • Ability to provide clear, actionable guidance in a fast-paced environment and manage multiple conflicting priorities and time-sensitive situations.
  • High degree of professional ethics and integrity.

Benefits

  • Starting base pay range of $217,877 to $260,733.
  • Eligibility for additional compensation, including bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and vesting after the first month of employment.
  • Flexible time off.
  • Generous parental leave.
  • Additional fringe perks.

Interested in this position?

Apply directly on the company website

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