About the Job
The Corporate Counsel provides legal advice and counsel to the Biopharma and Clinical Operations business units and supports day-to-day initiatives as well as long-term strategies. The role has the primary responsibility of drafting, reviewing, revising, and negotiating a broad range of agreements with biopharma companies and academic medical centers in the areas of genomic profiling, companion diagnostic collaboration, biomarker-driven clinical trial recruitment, and other areas.
• Deliver timely legal advice as needed to Biopharma, Clinical Operations, R&D and other teams.
• Identify potential legal issues and propose solutions to mitigate risk.
• Draft, review, revise, and negotiate a broad range of corporate agreements including, but not limited to, material transfer agreements, research and data-related agreements, agreements pertaining to licensing, services, consulting, supply, confidentiality, collaboration, clinical trial, as well as addenda amendments and statements of work.
• Manage multiple subject matter issues across diverse areas of the company, taking the initiative to identify appropriate subject matter experts and coordinating overall review.
• Identify legal issues, research new legal issues, and provide advice in a manner that integrates legal risk management with FMI’s business objectives.
• Advise on contract interpretation, dispute resolution, and legal risks.
• Develop and maintain strong business relationships across the company and contribute to cross-functional or departmental projects.
• Support the Legal Team’s efforts to effectively manage the delivery of legal services.
• Manage document production requests in connection with litigation matters, including compilation, distribution, associated communications, and record keeping.
• Appropriately triage workflow, set clear priorities and expectations with clients, and efficiently deliver results.
• Operate with limited supervision.
• Independently discern and establish priorities.
• Collaborate with colleagues in the Business Development, Corporate Management and Strategy, Research & Development, Commercial, and Finance functional areas.
• Other duties as assigned.
• Juris Doctor degree from an accredited, top-tier law school
• Admission to any state bar association in the United States
• 4+ years of prior legal experience
• Prior professional experience in-house at a life sciences company, healthcare company, relevant governmental agency, or for a law firm working on healthcare-related matters
• Proven ability/interest in working across a broad range of subject matter areas
• Significant experience drafting, reviewing, and negotiating corporate and commercial agreements, including but not limited to licensing, services, IT, research, consulting, clinical trial, and data sharing related agreements
• Expertise in the areas of corporate commercial healthcare and FDA regulatory law and regulation, including with respect to FDA labeling and promotional matters, healthcare fraud and abuse laws, pricing and reimbursement issues, U.S. international transparency laws and regulation, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of diagnostic products
• Ability to:
· balance a variety of projects with deadline pressures and limited supervision
· establish and maintain strong relationships within FMI’s business and Legal teams
· engage professionally with colleagues at all levels, including external partners, and to influence outcomes through effective leadership skills
· work in a dynamic, evolving and fast-paced work environment, with the confidence and abilities to work independently
• Experience with complex licensing, services, material transfer agreements, and collaboration agreements
• Experience with contract management software
• Prior professional experience advising business partners at all levels of an organization
• Strong legal research and analytical skills
• Demonstrated ability to prioritize numerous requests for assistance and offer superior work product and advice in a timely, thoughtful and complete manner
• Strong presentation skills, along with the ability to communicate effectively with individuals at all levels of the organization
• Sound legal and business judgment with the ability to identify and escalate legal issues when needed
• Exceptional verbal and written communication skills, with the ability to communicate complex issues in a clear way
• Well-organized with strong planning skills, and high attention to detail
• Track record of successfully influencing business outcomes
• Excellent interpersonal skills, with the ability to be a solutions-oriented and collaborative team player
• Unquestioned integrity, credibility, and judgment
• Ability to work well under pressure while maintaining a professional demeanor
• Understanding of HIPAA and the importance of privacy of patient data
• Commitment to values held at FMI: Patients, Innovation, Collaboration, and Passion
Internal applicants, please use your FMI email address.
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