About Cristcot
We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.
Job Summary
The Senior Director of Legal & Compliance will serve as the company’s lead legal and compliance professional, providing strategic and hands-on support across all functions of a small pharmaceutical organization focused on therapies for ulcerative colitis.
Primary Relationships
- Within Cristcot, the Senior Director of Legal & Compliance will collaborate closely with medical, marketing, sales, commercial operations, supply chain, regulatory and HR.
- Outside Cristcot, the Senior Director, Legal & Compliance will engage with external vendors.
Primary Job Responsibilities
The Senior Director of Legal & Compliance is responsible for overseeing legal, regulatory compliance, ethics, and risk management activities, while partnering closely with Medical, Regulatory, Commercial, and Executive leadership to ensure operations align with applicable laws, regulations, and industry standards.
The activities of the Senior Director of Legal & Compliance will include, but are not limited to:
- 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.
Skills and Qualifications:
- 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%.
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What We Do
We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.
