Senior Corporate Counsel (Commercial)

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BridgeBio ultimately exists to help patients. Millions worldwide are afflicted with genetic diseases, but small patient populations and industry reluctance to conduct early-stage development means that for many, treatments have not been forthcoming. We are committed to bridging this gap: between business case and scientific possibility, between patient and hope.

To learn more, visit us at https://bridgebio.com

Location

San Francisco, CA or New York, NY

Responsibilities

  • Provide advice, guidance and counsel to Commercial, Medical, Regulatory and other relevant functions on management and marketing strategies, product labeling, sales training and compensation, speaker programs, and policies, practices and initiatives with respect to compliance with relevant healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, FCPA, etc.)
  • Advise internal clients on projects, initiatives, and communications regarding products pending FDA approval
  • Represent the legal function in the review of advertising, promotional and educational materials submitted for review to BridgeBio’s Promotional Review Committee
  • Drive the finalization and rollout of a robust healthcare compliance program across BridgeBio, including development and enhancement of policies and procedures, risk assessments, monitoring, training and compliance communications
  • Coordinate with Head of Legal Affairs and BridgeBio management to ensure alignment on and communication of appropriate decision making on compliance
  • Partner with the business to proactively identify and mitigate areas of potential risk
  • Provide legal and compliance training to field and home office personnel and external consultants
  • Review and provide legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations
  • Work collaboratively with internal business clients on policies and procedures to ensure compliance with statutory and regulatory drug pricing and price reporting obligations under Medicaid, Medicare and the 340B program
  • Partner with internal business clients, colleagues across BridgeBio, and external counsel (as needed) to ensure programs meet established compliance standards
  • Support company product launch initiatives
  • Provide guidance regarding reimbursement and coverage matters
  • Partner with commercial regulatory and others regarding state licensing and distribution strategy
  • Provide legal support for a range of activities associated with implementing patient assistance and support programs
  • Provide guidance regarding Risk Evaluation and Mitigation Strategy (REMS) obligations
  • Provide guidance regarding relevant privacy laws
  • Provide legal and compliance advice and collaborative support to strategic alliance partners in certain markets where commercial rights have been granted to third parties, including in Asia Pacific
  • Draft, review and negotiate various agreements in support of all the foregoing, including third party vendor agreements, service agreements, distribution agreements, consulting agreements and other corporate agreements
  • Liaise and coordinate with BridgeBio affiliates and subsidiaries to ensure consistency and generate efficiency
  • Proactively identify legal risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals

Education, Experience & Skills Requirements

  • J.D. degree from a nationally-recognized law school
  • Admitted to practice in the U.S., preferably in California, or ability to register in California as in-house counsel
  • 12+ years as health law, life sciences or pharmaceutical compliance counsel either at a law firm, company and/or relevant government (e.g. FDA) agency
  • In-depth experience with the biotech or pharmaceutical industries, including business operations and regulatory framework
  • Experience with health care compliance and the rules and regulations concerning healthcare programs (including Medicare, Medicaid, 340B, etc.)
  • Experience drafting, reviewing and negotiating a wide variety of commercial agreements
  • Ability to develop legal strategy and objectives independently
  • Strong interpersonal skills and ability to communicate effectively verbally and in writing with a variety of contacts, including outside attorneys, senior management, and business associates
  • High degree of professional ethics and integrity
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • Willingness and ability to work with and coordinate activities across a large number of individuals across various departments

What We Offer

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
careers

Senior Corporate Counsel (Commercial)

Apply Now