The Role: The Head of Legal Affairs will serve as a member of the senior management team, leading all legal functions, fostering a proactive legal culture, and supporting a robust, comprehensive IP strategy to protect the company's cardiovascular pipeline of novel drug candidates. This role requires a strategic and hands-on partner with strong experience in the biotechnology space to support a leading cardiovascular company developing a portfolio of novel, clinical-stage programs and pre-clinical assets.
Here's What You'll Do: - Corporate Legal Functions
- Provide timely, relevant, and practical legal advice to senior leadership to help protect the company's interests while ensuring an appropriate balance of legal, ethical, and business considerations
- Manage all aspects of corporate governance, including board meetings and minutes, shareholder documents, corporate policies and related activities
- Ensure compliance with all laws, including those in foreign jurisdictions
- Lead complex business development transactions, including licensing and collaboration agreements
- Establish and maintain all standard contract templates; internal legal processes for contract intake, review, execution, and archiving.
- Manage existing agreements to ensure compliance with contractual obligations.
- Structure and negotiate CRO, CMO, and vendor agreements.
- Manage our network of external counsel (Corporate, Intellectual Property, Employment, etc.).
- Proactively identify legal risks and opportunities associated with business-critical activities to help the organization manage risk effectively
- Interpret laws, rulings, and regulations to advise the CEO and executive leadership team and manage risks.
- Manage complex legal matters and provide high-quality deliverables, including under tight timelines.
- Work effectively across functions and at all levels in the organization and with external parties.
- Engage with outside counsel and other external experts on applicable business initiatives and projects while maintaining financial efficiency.
- Leverage new technologies to enhance personal and functional effectiveness
- IP Strategy & Leadership
- Support and manage a comprehensive IP strategy that protects the Company's assets.
- Oversee the creation, filing, prosecution, and maintenance of patent applications in collaboration with outside patent counsel; manage deadlines, portfolio strategy, and global filing decisions.
- Partner closely with R&D, business development, and executive leadership to safeguard core scientific innovations
- Oversee corporate and IP diligence for business development activities.
- Collaborate with business development and corporate teams for licensing, collaboration, and partnering efforts.
- Clinical and Regulatory Support
- Provide legal oversight for clinical trials, including drafting and negotiating clinical trial agreements (CTAs) and informed consent forms (ICFs).
- Advise on FDA/EMA regulatory pathways, regulatory submissions, and compliance with healthcare laws, including anti-kickback regulations and data privacy.
- Manage compliance with data privacy regulations, including GDPR.
Here's What We'll Bring to the Table: - Highly competitive benefits package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
- Fully funded HSA for high-deductible PPO Plan
- 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately
- A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
- Flexible Spending Accounts for medical and dependent care expenses
- 4 weeks Paid Time Off annually
- 11 company paid holidays and Year-End shut down
Requirements
Here's What You'll Bring to the Table: - A Juris Doctor degree from an accredited law school, and licensed to practice in Massachusetts
- 15+ years of legal pharmaceutical industry experience counselling life sciences clients, in either an in-house role, in private practice or a combination of both.
- Significant experience drafting agreements, including but not limited to clinical trial site agreements, CRO agreements, manufacturing and other supply chain agreements and licensing agreements, etc.
- Proven track record of effectively partnering with business teams throughout the transactional and negotiation process from beginning-to-end, to provide practical, timely, and solution-oriented advice, and to efficiently bring contracts to a favorable close.
- Capable of appropriately triaging multiple workflows simultaneously, setting clear priorities and expectations with clients and external parties, and efficiently delivering results in a pragmatic and risk-balanced manner, ensuring a strong level of detail-orientation while still delivering results on time.
- Ability to develop and maintain strong business relationships across the company and contribute to cross-functional or departmental projects, including demonstrated ability to identify potential legal issues and propose solutions to address business requirements while appropriately mitigating risk
Must have prior experience in-house at a biotech or biopharma.
