SENIOR COUNSEL
Melinta Therapeutics is a biopharmaceutical company with strong commercial and medical capabilities dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. Melinta’s current portfolio includes seven commercial stage products and one investigational product under review by FDA: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate), VABOMERE® (meropenem and vaborbactam), and cefepime-taniborbactam. With an unsurpassed commitment to providers and patients, Melinta is dedicated to saving lives threatened by the global public health crisis of infections. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.
Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.
Job Purpose
Reporting to the General Counsel, the Senior Counsel is an integral member of the Legal team and is responsible for supporting the execution of the Company’s legal and compliance functions and working cross-functionally to assist in managing the legal risk of the Company. This role will serve as the primary counsel to the Commercial and Medical Affairs teams, providing seasoned legal advice on matters related to promotional and educational activities and materials, interactions with healthcare providers and organizations, and other applications of healthcare and regulatory compliance in the pharmaceutical industry.
Duties and Responsibilities
Serve as a business and legal partner for the Medical Affairs and Commercial departments, including Market Access, Sales, Commercial operations and other customer-facing teams; advise business stakeholders at all levels of these departments, including senior management Provide strategic counseling and skillful advocacy related to the marketing, sale, education on, and distribution of pharmaceutical products in compliance with related federal and state laws and regulations, including the Food, Drug & Cosmetic Act, False Claims Act, and Anti-Kickback StatuteEvaluate risks regarding business decisions and operations, apply effective, pragmatic risk management techniques and offer solutions-oriented advice on potential legal issuesServe as legal representative and chairperson of the Promotional Review Committee with accountability for the optimization and oversight of the review process for sales, marketing and field training materials Draft, review, and negotiate a wide variety of agreements including confidentiality, vendor, consulting, grant, sponsorship, and other agreements, including agreements in connection with promotional and medical programs and other relevant product mattersSupport business development activities, including diligence, in the areas of promotional and regulatory complianceProvide legal guidance on Company’s compliance program and support execution of compliance program and needs of the Compliance team, including the creation and enforcement of Company policies and procedures, risk assessments, and ongoing monitoringAssist with investigations and resolutions of compliance and other regulatory related mattersDevelop and provide legal and compliance training to Company stakeholders and external consultantsReview and advise on a variety of strategies and tactics to help drive Company’s strategic priorities Keep current with evolving legal, regulatory and business issues, including enforcement actions and trends, OIG advisory opinions, and developing laws affecting the pharmaceutical industryManage outside counsel on a variety of matters
Qualifications
8-10 years of experience in-house in biotechnology and/or pharmaceutical industries, supporting late-stage development, launch, and mature productsAbility to provide legal and regulatory counsel on multiple, commercial-stage products in Company portfolioDeep knowledge of federal and state pharmaceutical and healthcare compliance laws and regulations, including the FD&CA, FCA, AKS, OIG guidelines and advisory opinions, PhRMA Code, privacy (including GDPR and CCPA), and Open Payments and other transparency obligationsHigh degree of integrity, ethics and accountabilityDemonstrated ability to thrive under pressure and exercise practical, seasoned judgment in a fast-paced and dynamic environment Well-developed organizational/project management skills, with strong attention to detail Proven leadership capabilities, with a talent for cultivating strong cross-functional relationships and successfully influencing colleagues as a trusted business and legal partnerBusiness acumen, including a well-developed understanding of the pharmaceutical industry and the willingness to be a hands‐on, Company leader capable of both identifying legal challenges and presenting positive, creative solutions and alternatives to such issuesExcellent communicator (in both written and verbal form), with the ability to drive discussions to effective and actionable decisionsCapable of triaging and prioritizing workflows and establishing clear priorities and expectations with stakeholders, and efficiently delivering results in a timely and pragmatic mannerExperience with buy-and-bill products a plusExperience in counseling on privacy related topics a plus
Education
Juris Doctorate from an accredited, reputable law schoolMember in good standing of a state bar; New Jersey preferred
Position Type
Full TimeHybrid schedule: three days per week in NJ headquarters office
Travel
Occasional travel required
Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.