Senior Corporate Counsel, R&D

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.  For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.  At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.  Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.  We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 

Summary of Role:

We are looking for an attorney with 10+ years of relevant pharmaceutical/biotech industry experience to join the Lantheus Legal Department as Senior Corporate Counsel, R&D, responsible for identifying and resolving complex legal issues, clearly communicating legal and business risk, and advising on appropriate, practical strategies to manage risk and maximize business benefit to achieve business objectives relating to our R&D pipeline. Candidates should have experience counseling in-house business partners on legal topics relevant throughout the research and development phase of a product candidate, including materials transfers, research collaborations, licensing, establishing, and executing clinical research programs and related contracting activities. This attorney will collaborate with brand attorneys in preparation for commercial launch and work on other legal matters. Experience counseling on medical devices is a plus.

This position will serve as the primary legal business partner for the Lantheus R&D business teams and Innovation Office providing strategic legal and business advice and implementing strategic partnerships designed to achieve the Company’s R&D and commercial goals.

Key responsibilities:

Partnering with and advising all levels of the organization to facilitate compliant development, execution and achievement of corporate objectives focusing on our pipeline assets, including:

• Forming strong relationships and integrating closely with all relevant stakeholders to plug into and contribute to the Company’s pharmaceutical development, clinical development, regulatory, medical and commercial strategies regarding its preclinical and clinical assets.
• Pre-clinical and clinical development of the Company’s pipeline assets, including
• Drafting, negotiating, and interpreting a wide variety of agreements relating to the research and development of diagnostics, therapeutics and artificial intelligence solutions.
• Clinical Research Organization arrangements and other service provider agreements, for example,
• Clinical trial arrangements with investigators,
• Clinical trial supply / manufacturing agreements
• Informed consent and other clinical trial participant related matters, for example
• Patient privacy and rights
• Data integrity
• Clinical trial disclosure requirements including pharmacovigilance and drug safety matters,
• Collaboration/alliance agreements with academic and industry research and development partners,
• Supporting investigator-initiated trials.
• Strategic transactions relating to the Company’s pipeline assets, including
• Structuring, drafting and negotiating term sheets and appropriate agreements with academic and industry partners to acquire and/or make available pipeline assets, for example
• Licenses, collaborations, other strategic alliance relationships,
• Beta testing agreements,
• Collaborative development of potential companion diagnostics and/or artificial intelligence tools.
• Conducting related due diligence reviews.
• Identifying and resolving legal and business issues.
• Managing strategic business/alliance relationships, including managing disputes and clarifying the Company’s rights and responsibilities to enforce them through governance mechanisms or renegotiation of terms.
• Ensuring the business is kept abreast of relevant legal developments.
• Reviewing and advising on media relations materials, investor presentations, press releases, web sites and other company communications related to R&D matters.
• Other responsibilities as assigned.

This role will interact closely with our intellectual property, transactions and brand legal teams and various internal stakeholders at all levels of the organization including partnering with business leaders and cross-functional pipeline asset teams as well as with our Ethics and Compliance team to proactively mitigate identified areas of risk relating to our pipeline programs.

Awareness of current enforcement trends and compliance expectations relevant to the pharmaceutical industry is expected as is substantive working knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry generally and research and development activities specifically, including without limitation:

• US Federal healthcare program requirements under the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the Transparency (Sunshine Act) Provisions of the Patient Protection and Affordable Care Act, US Antitrust laws,
• Foreign Corrupt Practices Act,
• US FDA regulations relating to clinical trials and good clinical practices in the US and ex-US (e.g. ICH, 21 CFR),
• US and EU privacy laws

This role is an individual contributor role reporting to the Senior Vice President, Legal Affairs and will be based in Bedford, Massachusetts.

Professional Skills:

The successful candidate should possess the following attributes:

• High level of professionalism and integrity, sound judgement and a strong commitment to ethical conduct.
• Strong organizational skills and ability to work independently handling multiple and sometimes conflicting responsibilities simultaneously while meeting high quality and timeliness standards in a dynamic, fast-paced environment.
• Sophisticated emotional intelligence, strong interpersonal skills and proven ability to work collaboratively in cross-functional/multi-disciplinary teams.
• Strong verbal and written communication skills.
• Ability to effectively communicate legal advice in a simple and straightforward manner, including the ability to: (i) understand and digest complex scenarios, (ii) manage differing opinions, ambiguity and conflict effectively, (iii) identify and evaluate relevant legal issues and risks, (iv) propose practical, risk-based solutions that take into consideration the relevant business objectives, (v) communicate issues, risks, and solutions clearly and concisely to lawyers and non-lawyers and (vi) escalate issues appropriately.
• Ability to exert “soft influence” and build consensus without direct line management oversight.
• Commitment to proactively identify opportunities for improvement and engage with appropriate stakeholders to propose solutions.
• Ability to effectively and efficiently manage outside counsel, when used, and adhere to a budget.
• Position may require travel and will include other duties as assigned.

Qualifications:

• JD from an accredited law school and a valid license to practice law (Massachusetts license is preferred).
• 10/13+ years of relevant legal experience including within the pharmaceutical/biotech industry.
• Experience counseling in-house business partners on legal matters of importance to the pharmaceutical industry, including the development of diagnostic, therapeutic and/or artificial intelligence assets regulated as drugs and/or medical devices in the US and ex-US.

Core Values:

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone’s health is in our hands
• Own the solution and make it happen

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