Cristcot · 5 hours ago
Senior Director, Legal & Compliance
United States
Full-time
Remote
Director/Executive
8+ years expCristcot is a small pharmaceutical organization focused on therapies for ulcerative colitis, seeking a Senior Director of Legal & Compliance. This role is responsible for overseeing legal, regulatory compliance, ethics, and risk management activities, while partnering closely with various departments to ensure operations align with applicable laws and regulations.
Health CareMedicalMedical DevicePharmaceutical
Responsibilities
Serve as a subject matter expert and strategic advisor to leadership and business stakeholders on complex compliance matters, establish strong collaboration channels and relationships across our teams, and interface with external regulators as necessary
Analyze regulatory standards and publications to provide actionable insights and strategic compliance guidance to stakeholders
Develop compliance training programs, executive dashboards, and monitoring systems to identify gaps and validate program effectiveness
Lead cross-functional compliance initiatives across Finance, People, Marketing, Product, and other teams, while coordinating and leading the Compliance Committee
Lead the development, implementation, and management of an effective enterprise compliance program
Monitor commercial and non-commercial programs and contracts for adherence to company’s policies including its Code of Conduct
Provide compliance guidance on promotional and non-promotional materials to minimize risk and participate on promotional review committee. In addition, serve as Legal reviewer on promotional review committee and non-promotional review committee
Review and approve annual engagement plans and business needs reviews for HCP engagement in connection with Commercial, Sales and Marketing and other departments, including review of HCP agreements
As a member of the Legal Affairs and Compliance group, provide Legal and Compliance review of agreements as needs arise
Pivot fearlessly: Be prepared to adjust US compliance strategies and operations in response to new data, regulatory changes, or internal audit findings, ensuring that the organization remains agile and compliant
Accept risk: Develop and implement US compliance strategies that recognize the inherent risks in the pharmaceutical industry, embracing these risks as necessary for impactful innovation and progress
Provide guidance on complex compliance matters like anti-bribery, anti-corruption, conflicts of interest, and interactions with healthcare providers, ensuring consistent and practical advice
Collaborate with internal Legal and Regulatory compliance team to implement tailored compliance initiatives and training programs
Assist in drafting and updating compliance-related agreements and provide support to Legal and commercial teams on compliance provisions
Develop and maintain a deep comprehension of Company processes, systems, technologies, data, customers, end users, vendors, and the compliance
Stay informed about industry regulations, best practices, and emerging trends in healthcare compliance and regulatory environments
Conduct regular risk assessments to identify compliance issues and develop strategies to mitigate risks. Monitor and audit the effectiveness of the compliance program, and when necessary, conduct internal investigations into potential violations of our Code of Conduct and company policies, working with the Legal Department
Qualification
Required
Juris Doctor (JD) from an accredited law school
Active bar membership in at least one U.S. jurisdiction
Minimum of 8–10 years of relevant legal and compliance experience in the pharmaceutical, biotechnology, or life sciences industry
Demonstrated experience supporting FDA-regulated products, preferably in gastroenterology, immunology, or specialty therapeutics (ulcerative colitis experience a plus)
Hands-on experience with Medical Legal Review (MLR) and participation in Promotional Review Committee (PRC) processes
Strong working knowledge of FDA regulations, healthcare compliance laws, and industry codes (e.g., PhRMA Code)
Experience operating in a small or emerging pharmaceutical company environment, with the ability to be both strategic and hands-on
Sound judgment with the ability to balance legal risk and business objectives
Strong communication, negotiation, and stakeholder management skills
High ethical standards and attention to detail
Ability to work independently and manage competing priorities in a fast-paced environment
Ability to travel <15%
Company
Cristcot
Cristcot focuses on drug delivery systems that combine products and specialty drug formulations.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$32.98M2025-06-06Series Unknown· $10.47M
2019-10-23Series Unknown· $13.73M
2018-09-12Series Unknown· $3M
Leadership Team
Jennifer Davagian
President and CEO
Richard Warburg
Board Of Directors
Recent News
2025-06-24
2025-06-11
Company data provided by crunchbase