Description:
This role is considered:Virtual
This role is considered Virtual.
Overview:
The Director, Legal Counsel will be a member of the Global R&D Legal practice area. Global R&D Legal supports three key A RNAi Therapeutics Biopharmaceutical Company functions: Research Development (ReDev), Development & Medical Affairs (DMA), and Global Technical Operations and Quality (TOQ). This role's primary focus will be supporting TOQ (Manufacturing, Supply Chain, Quality, CMC, Facilities) while also supporting Research & Early Development (ReDev) and DMA, as assigned. This role will report to the Vice President, General Counsel, Research & Development.
This is a hybrid or remote role that requires periodic in-person engagement with a large TOQ organization in Cambridge, MA and Norton, MA.
Key Responsibilities:
Legal Support for Global Technical Operations and Quality (TOQ)
- Provide legal advisory and strategic support to Global TOQ team (Manufacturing, Supply Chain, Quality, CMC, and Facilities).
- Partner with TOQ, Clinical Development, Commercial, Legal, Ethics & Compliance and other business colleagues worldwide to (i) advise and help implement TOQ business strategy, (ii) structure applicable transactions that deliver on that strategy, and (iii) negotiate and execute agreements in accordance with those requirements and the company's overall objectives, priorities and policies.
- Serve as a key resource to address legal and contracting issues related to A RNAi Therapeutics Biopharmaceutical Company's global clinical and commercial supply chains.
- Participate in cross-functional team meetings to ensure TOQ business partners are achieving targeted goals
- Review and negotiate TOQ agreements (Supply Agreements, MSAs, Packaging and Labeling Agreements, Distribution Agreements).
- Partner with Global R&D Legal colleagues to provide comprehensive legal support to A RNAi Therapeutics Biopharmaceutical Company's R&D functions.
- Provide legal, business and strategic advice on relationship support by interpreting contract language for internal business partners to help avoid and/or resolve potential issues. Also, partner with business partners on managing third party relationships.
- Provide best-in-class legal support for policies, processes, templates, governance principles and support structures that allow A RNAi Therapeutics Biopharmaceutical Company to successfully grow and scale globally.
- Partner with IP Legal and Business Development Legal to address potential IP issues and support A RNAi Therapeutics Biopharmaceutical Company's relationships with collaborators, respectively.
- Partner cross-functionally and collaborate with business and legal stakeholders acting as enterprise connector to ensure global excellence, consistency and compliance with all R&D activities.
- Contribute to process improvements across our Legal department and organization, as needed.
- Identify and effectively communicate priorities and urgencies to applicable stakeholders.
Qualifications:
- Juris Doctor degree required; An advanced science degree in chemistry or other area relevant to TOQ is preferred
- Minimum 8+ years' experience dedicated to drafting, negotiating, and advising on TOQ matters with an emphasis on drafting/negotiating agreements and advising on all TOQ areas (in-house and/or a nationally recognized law firm).
- Experience in partnering with TOQ business partners to provide advisory and strategic support.
- Experience or knowledge in supporting Early Development and/or Development/Medical Affairs organizations
- Demonstrated exceptional communication skills, including presentation, interpersonal interactions, and written communications
- Experience effectively working with all levels in the organization
- Demonstrated commitment to finding solutions, relationship building, continued learning, proactivity and a high sense of confidentiality
- Excellent interpersonal skills that are demonstrated by being articulate, direct and forthright, and serving as a collaborative and decisive team member and a strategic thinker with a broad perspective
- Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations
- Willing to support any areas of Global R&D, as needed.
- Demonstrated ability to own projects and consistently meet tight timing requirements and high quality standards
- Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization
