Description:

Summary of Position:
The A Commercial-Stage Biopharmaceutical Company Legal Department is looking for an experienced and business-minded Assistant General Counsel (“AGC”) who can be immediately impactful within our ethical, fast-paced, solution-oriented culture. The AGC will serve as the primary legal support for regulatory and healthcare legal matters related to the development, marketing and sale of the Company's products and product candidates. This attorney will provide practical, strategic advice and counsel and must have a robust understanding of applicable laws, rules, and regulations including the Food, Drug and Cosmetic Act, FDA guidances, PhRMA Code, Prescription Drug Marketing Act and Anti-kickback and False Claims statutes. The AGC will work closely with various functions across the Company including Commercial, Medical, Regulatory, and Clinical and will be responsible for driving discussions and providing a high degree of input into strategic decisions. Key responsibilities will include supporting pharmaceutical pricing, reimbursement and market access activities including the drafting and negotiation of third-party contracts such as public and private payers, PBMs, and specialty pharmacies. The position will report to the General Counsel.

Position Responsibilities:
The roles and responsibilities will include the following:

Provide robust counsel and guidance regarding the legal implications of matters pertaining to the operations of the business, including regulatory compliance, litigation and risk management
Serve as a trusted business partner and subject matter expert in the areas of regulatory and healthcare compliance law to Commercial and Medical Affairs teams and provide advice on programs, initiatives, and contracts related to sales and marketing, market access, and non-promotional activities
Draft, review and revise a broad range of commercial agreements including agreements with healthcare professionals and providers, vendors, licensors, consultants and speakers as well as other types of agreements supporting the business
Provide proactive and strategic advice and counsel on product pricing, government price reporting requirements, as well as drafting and negotiating third-party contracts such as public and private payers, PBMs, GPOs and specialty pharmacies
Support the General Counsel in managing significant litigation matters and disputes
Review and advise on key regulatory filings and briefing documents
Review and advise on corporate materials including promotional and advertising materials, sales training materials, internal and external corporate communications
Partner with other colleagues to identify training needs within the organization and develop and present training sessions on relevant laws and legal/business issues
Stay abreast of and communicate to the organization significant pending and actual decisions, legislation and regulatory rulings that may affect the company in the area of healthcare law
Establish processes, policies and procedures as appropriate
Maintain clear and regular communications with the Board, Management Team and other stakeholders, as appropriate
Provide guidance to and manage external legal counsel as required

Candidate Requirements:
Skills and Competencies:

Excellent interpersonal skills
Demonstrated negotiation capabilities and persuasion skills
Unquestionable ethics and integrity
Sound judgment, with an understanding of the intersection of legal, regulatory and business issues
Strong intellect and solid business acumen, coupled with pragmatic and problem-solving skills
Innovative, strategic and pro-active in anticipation of the future needs of the Company
Proven “hands-on” approach with solid relationship-building and listening skills
Ability to understand, simplify and clearly articulate complex issues
Well organized and detail oriented with demonstrated ability to manage time, handle a variety of tasks and responsibilities, and meet timelines without supervision
Possess the credibility and gravitas to be viewed as a trusted advisor

Minimum related experience required to perform job

At least ten years of in-house pharmaceutical legal experience including experience in senior legal position at small pharmaceutical/biopharmaceutical/biotech company
Well-rounded, experienced generalist who has played a key role as an engaged leader on matters relating to the marketing and promotion of pharmaceutical products and possesses an impressive track record of providing not only sound legal advice, but also excellent business judgment concerning overall legal strategy, regulatory compliance, and risk management
Previous experience implementing infrastructure and processes to support the commercialization phase of a biopharmaceutical/biotech company
Previous experience managing others

Education: