Vice President, Head of Legal Affairs

Cardurion Pharmaceuticals, Inc. • Burlington, MA

2d

About The Position

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease. 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.

Requirements

• 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.

Responsibilities

• 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
• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: No Education Listed