Head of Legal - US

Summary Overview:

Responsible for performing, managing and supervising legal and compliance work and activities pertaining to the Life Molecular Imaging’s the US business, including without limitation corporate, commercial (sales, marketing, manufacturing, distribution, licensing, operations), medical affairs and compliance related work.   

Key Responsibilities:

• Provides legal advice to corporate, commercial (sales, marketing, manufacturing, distribution, licensing, operations), medical affairs and compliance departments of the Life Molecular Imaging business either directly or via external counsel management. 
• Provide legal and compliance advice to the business and its leaders and stakeholders, identify and mitigate legal and compliance risks, and develop and advise on the legal and compliance aspects of company policies and procedures.   
• Understands the needs and priorities of the LMI strategy and the business; oversee the delivery of internal and external legal services and resources to accomplish corporate objectives, strategies, and priorities,
• Drafting, negotiating, and reviewing of commercial contracts covering the entire product lifecycle and supply chain, involvement in rest of world (ex-US) business expansion either via own Marketing Authorization set-up or via licensing arrangements with third parties, and involvement in merger & acquisition projects including without limitation due diligence. 
• Support of Medical Affairs Division, in collaboration with US and EU Legal teams as needed.
• Builds relationships with and maintains an effective on-going dialogue with internal and external stakeholders. 
• Identifies risks and ensures that these are allocated appropriately to protect the business.  
• Undertakes reporting as required to ensure line manager is aware of key priorities and issues. 
• Develop templates and precedents to bring consistency to contractual arrangements. 
• Understands the regulatory environment and is up-to-date, particularly within the healthcare sector market. 
• Will develop and lead US corporate legal and compliance strategies to promote and protect LMI’s interests, work collaboratively with legal and compliance colleagues in other regions and/or at LMI’s parent company,
• Understands the regulatory environment and ensures legal compliance by creating, updating, implementing, monitoring, and enforcing policies, procedures, guidelines, and manuals.
• Will be responsible for supporting internal and external audits, oversight of the compliance function to ensure implementation and maintenance of the group compliance program and complementary policies for the territories LMI entities are operating in and will, as such, will serve as compliance liaison for the Head of Compliance South Africa. 
• Work with Chief Financial Officer (GmbH) to liaise with tax and insurance consultants as needed. 
• Develop and provide legal and compliance related training across the organization.
• Assist the LMI US business with legal aspects of US Human Resources/Labor requirements when appropriate. 
• Will be point of contact for parent company’s legal and compliance departments to support audits, reporting, and policy and procedure implementation to US employees.
• US qualified lawyer licensed to practice in lawyer’s US state of residence.
• Ten years of progressive post qualification experience in the pharmaceutical, life sciences, biotech and/or medical device industries required, with familiarity of the (radio)pharmaceutical industry in both pre-commercial (research) and post approval (FDA NDA/INDs) settings.  
• Experience supporting healthcare economics and market access preferred.
• Demonstrable commercial awareness and acumen. 
• Excellent drafting and negotiation skills and experience with complex commercial agreements. 
• Exposure to pharmaceutical IP and licensing issues with respect to contracting and able to negotiate such issues to a favorable position for LMI. 
• Previous experience in dealing with applicable healthcare and nuclear regulatory and safety/environmental agencies preferred.  
• Knowledge and experience advising on issues regarding compliance, risk management, and data privacy and data protection required.  
• Budget preparation and fiscal management experience.
• Five years of supervisory or management experience including employee development and performance management skills.

Salary : $210