JOB DESCRIPTION

The Senior Vice President (SVP) of Legal, Compliance, and Operations will be responsible for overseeing the company's legal affairs, corporate compliance, and designated  operational functions. This role requires a strategic leader with a deep understanding of the biotechnology industry, specifically in oncology, and the ability to navigate complex regulatory environments. The SVP will partner with cross-functional teams to ensure that the company operates in full compliance with legal, regulatory, and ethical standards while driving operational efficiency to support the company’s growth. This role requires four days a week in person at our office with option for one day remote.

KEY RESPONSIBILITIES

Legal 

• Oversee standard legal matters, including intellectual property (IP), corporate governance, contracts, employment law, and litigation.
• Efficiently handle in-house legal work, including drafting and reviewing contracts related to clinical trials and vendors (e.g. confidentiality agreements, clinical trial agreements, master services agreements, material transfer agreements, etc.), while exercising sound judgment in managing and optimizing the use of outside counsel when necessary.
• Provide counsel to the C-Suite and the Board of Directors on legal risks and mitigation strategies.
• Provide guidance on intellectual property matters, including patent, trademark, and copyright issues, managing external counsel to ensure high quality and cost-effective support.
• Manage litigation and dispute resolution matters, including coordinating with external counsel, conducting investigations, and representing the company in legal proceedings as necessary.
• Support corporate transactions as needed, including mergers and acquisitions, joint ventures, and strategic partnerships (working closely with CBO).
• Review and optimize current use of external counsel both with regards to quality and cost effectiveness.
• Ensure compliance with and proactive awareness of federal, state, and international laws, regulations, and industry standards applicable to biotechnology and clinical-stage companies.
• As corporate secretary, record and distribute board meeting minutes
• Ensure effective communication and collaboration between legal, compliance, and operations teams with other departments, including R&D, clinical, regulatory, finance, and business development functions.

Compliance

• Develop and implement compliance programs to adhere to FDA, EMA, and other regulatory requirements related to clinical trials and eventual product commercialization.
• Lead the design and enforcement of corporate policies, codes of conduct, and ethics programs to promote a culture of integrity across the organization.
• Monitor evolving regulations and guide the company in proactively adjusting policies and procedures to ensure ongoing compliance with healthcare, data privacy (GDPR), and anti-bribery (FCPA) laws.
• Oversee internal audits and risk assessments, ensuring that identified risks are mitigated in a timely and efficient manner.
• Collaborate with regulatory affairs and clinical operations teams to ensure compliance in product development, clinical trials, and interactions with healthcare professionals.

Operations

• Lead and optimize the company’s operational functions, including IT, facilities management, and general corporate services.
• Drive process improvement initiatives across the organization to increase efficiency, reduce costs, and support scalability as the company grows.

QUALIFICATIONS

• JD from a top-tier law school and active membership in good standing with the relevant state bar association.
• Minimum of 10 years of relevant legal experience, preferably both at a firm and at least one recent leadership role in house for a biotechnology or pharmaceutical company
• In-depth knowledge of FDA regulations, EMA guidelines, and other global regulatory requirements for clinical-stage and commercial-stage biotechnology companies.
• Familiarity with data privacy laws impacting clinical trial data and biospecimen handling including state-specific data privacy laws, EEA GDPR and UK GDPR
• Demonstrated experience leading operations in a dynamic, high-growth environment, with a strong understanding of corporate infrastructure and scalability needs.
• Strong analytical and problem-solving skills, with the ability to analyze complex legal issues, identify creative solutions, and make sound recommendations to senior leadership.
• Excellent communication and interpersonal skills, with the ability to communicate complex legal concepts clearly and effectively to non-legal stakeholders at all levels of the organization.
• Ability to thrive in a fast-paced, dynamic environment, with the flexibility to adapt to changing priorities and navigate ambiguity with confidence and resilience.

COMPENSATION

Approximately $250,000-$300,000 base salary which may vary depending on qualifications, experience, and ultimate leveling. Total compensation package includes eligibility for an annual performance bonus and equity, along with a competitive benefits package.