Spero Therapeutics Corporate (Commercial) Counsel in Cambridge, Massachusetts
Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide, formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis. Spero is also advancing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero’s third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections.
We sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings
General Scope and Summary of Role
Spero Therapeutics is looking for a collaborative, enthusiastic partner responsible for supporting our commercial, medical affairs and regulatory affairs teams by providing quality legal counsel with both unwavering integrity and a dedication to corporate objectives and growth. This role provides candidates with an opportunity to serve as the principal advisor to the Executive Leadership Team and other employees on issues involving FDA legal issues. This lawyer will conduct a variety of legal work including advising on market access, sales and marketing, data analytics, and medical affairs strategies and materials. The role will also involve contract negotiation and drafting, establishing and conducting employee training on legal issues, supervising outside counsel, and creating and implementing compliance policies.
What You’ll Do
Provide comprehensive legal advice and support to the commercial, medical affairs, and regulatory teams based on applicable laws, regulations, and Spero policies and guidelines.
Analyze advertising and promotional materials, non-promotional disease state and medical materials, and advisory board materials.
Identify and analyze legal and commercial risks and advise relevant leadership teams.
Prior to the expected hire of a Chief Compliance Officer in Q4 2021, partner with the CLO and outside counsel in establishing a healthcare compliance infrastructure, including policies, training and procedures for a pre-approval environment.
Actively participate in knowledge-sharing among the legal and compliance teams
Act as a business partner to Compliance in connection with training and other activities
Serve as a member of various cross-functional teams, including Spero’s Medical Legal Regulatory Committee and Compliance Committee.
Focus on strategy and program development, contracting, risk mitigation, policy development and review, and activities regarding interactions with healthcare providers, group purchasing organizations, payers, and other stakeholders.
Drafting, reviewing and negotiating legal agreements with variety of service providers and customers in the areas of federal contracting requirements, contracting with Group Purchasing Organization (GPOs), Specialty Pharmacies and Wholesalers, and have experience with Fair Market Value assessments for determining appropriate pricing for commercial contracts.
Advising key stakeholders on legal, regulatory and policy developments to ensure that legal support is adapted to a rapidly changing environment.
Overseeing discount agreement interpretation and contract enforcement, advising and managing commercial dispute resolution, including providing support for audits
Developing and providing ongoing training to commercial operations staff regarding legal and regulatory requirements for commercial activity and contract requirements in the biopharmaceutical industry
Coordinating legal support by contributing as a member of cross-functional teams and interacting with business and law department colleagues on various matters
What You’ll Need
10+ years of legal experience, with experience in a pharmaceutical/ biotechnology company with launch experience strongly preferred.
Licensed to practice law and in good standing in Massachusetts, or ability to register as in-house counsel in Massachusetts.
Experience in drafting commercial contracts, advising on commercial and medical activities, regulatory matters, and compliance issues.
Working knowledge of US healthcare compliance considerations, False Claims Act, Anti-kickback Statute, and FDA rules and regulations, and other applicable laws, regulations, and codes
Demeanor/gravitas needed to negotiate with sophisticated purchasing and legal teams (including outside counsel) and present to and advise the Executive Leadership Team.
Strong transactional skills including experience drafting and negotiating pharmaceutical or medical device related commercial contracts on the sell-side is required.
Must possess the ability to think strategically and apply strong analytical skills.
Must have strong communication and presentation skills and be a highly effective collaborator in a team-based matrix environment.
Excellent skills in drafting, analyzing and communicating contractual terms to internal clients.
Ability to appropriately balance legal and business risks while complying with short turnaround cycles.
By joining our committed and highly motivated team, you’ll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero’s culture is one that emphasizes “servant leadership,” or putting ego aside and working for the benefit of the team and our patients and values our colleagues’ opinions and celebrates accomplishments in service of patients.
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