Senior Director, Legal & Compliance, Europe

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others.Position Summary:The Senior Director, Legal & Compliance Europe at Crinetics Pharmaceuticals Europe GmbH (the “Company”), will serve as a valued member of the global legal department and work with the European Leadership team partnering cross-functionally with other key stakeholders to assist the Company in achieving its purpose and goals in Germany. The Senior Director will work directly with the Associate General Counsel, Global Commercial Legal to support EU leaders on local Commercial Legal matters including, but not limited to, promotional and Medical Affairs activities and materials, vendor and HCP contracts, market access issues, and other Commercial Legal matters consistent with Crinetics Global Commercial strategies and processes. The Senior Director, Legal & Compliance Europe will also collaborate closely with the VP of R&D Legal for local legal support including but not limited to working on CDAs, Ancillary Service Provider Agreements, Advisory Board and Steering Committee Consulting Agreements, German Data Processing Agreements, QA Agreements, Chemistry, Manufacturing, and Controls (CMC) related Agreements, as well as a variety of German Vendor Agreements. and have demonstrated experience tailoring global compliance policies to fit The candidate must understand and be able to provide strategic advice regarding local market and EU compliance standards consistent with all relevant legislation and regulations.The candidate must be able to apply to identify and successfully mitigate legal, compliance and business risks while operating as a team player, possess a strong work ethic, analytical skills, and deliver pragmatic solutions on a broad range of legal topics.This role supports the strategic objectives of the organization through engagement and interaction with key functional team members in Europe, such as Clinical Operations, Medical Affairs, Regulatory, Commercial, Supply Chain, Finance, Human Resources, Quality Assurance, and Commercial. The Sr. Director will work alongside European and US counterparts, as well as effectively and efficiently engaging external counsel for specialized matters to support the Company’s overall objectives and needs of the European team. Duties include those associated with a pharmaceutical in-house legal and compliance counsel, that would allow the organization to meet its business objectives while complying with its legal and compliance obligations as well as managing regional Company governance matters. Candidates should thrive in a fast-paced environment and be able to set up and expand current legal and compliance operations.Essential Job Functions and Responsibilities:These may include but are not limited to:Provide strategic legal advice to European leaders to effectively manage legal and compliance risks relating to product launch readiness in Germany or other countries in Europe.Draft, review and negotiate contracts with European clients, partners, vendors, HCPs and HCOs.Work directly with the Associate General Counsel, Global Commercial Legal to support EU leaders Set up the legal framework and systems in Europe that would allow for scalable business over time, e.g. establishing policies and processes in cross-functional collaboration with Market Access, Regulatory, Medical Affairs, Supply Chain and Commercial Ops team. Assist in structuring key business initiatives in a manner that helps the Company achieve objectives while at the same time protecting legal, regulatory, compliance, and tax directives and considerations. Establish a local Compliance Program: interaction with HCOs, HCPs, e.g., Ad Boards, KOLs engagements, etc. in alignment with Crinetics global compliance program to effectively manage risk.Provide training to EU staff related to legal and compliance topics.Evaluate current policies and SOPs, draft and/or redraft necessary policies/SOPs as needed and implement and facilitate training.Partner with Finance on legal entity setup, funds-flow and intercompany topics.Support EU corporate maintenance.Manage and refine library of template agreements for local use.Supervise, delegate, and oversee specialized work e.g. Labor and Employment, Anti-gift and Transparency by outside counsel.Support the human resources department as needed with respect to European labor and employment matters.Develop functional plans for managing legal matters, including activities to be performed in-house or through third-party providers, to efficiently manage Crinetics’ overall budget, its legal activities and minimize risk for the business.Partner effectively cross-functionally to ensure compliance with industry codes of practice and applicable regulatory, privacy, pharmacovigilance and quality requirements.Work collaboratively and creatively with internal clients and other functions in an individual capacity and as part of matrixed teams to understand strategic objectives and assist in execution of agreed-upon tactics.Lead special projects as assigned and participate in cross-functional teams and committees while demonstrating leadership ability to colleagues and business partners.Stay informed and advise company on new laws, regulations, and industry trends affecting the organization. Prepare and deliver relevant training as needed.Demonstrate knowledge and understanding of the Pharmaceutical industry regulations, bribery and anti-kickback laws, privacy, promotion/education, and EU healthcare compliance rules, regulations, and best practices. Other duties as assigned.Education and Experience:Strong academic credentials including degree qualification in German Law and working experience with European Laws. 15+ years of relevant legal pharmaceutical/biotech experience in-house with at least 10 years of experience supporting clinical trials drugs development, experience with new drugs launch, market access and the commercial organization of a global pharmaceutical company. Such experience to include legal, healthcare and general corporate compliance, and privacy.Proactive approach to finding solutions to legal obstacles that start-up pharmaceutical companies face when initiating their business in EuropeOne who thrives in a fast-paced, challenging environment.Understanding of the difference between remote and real risks and gauge the threat of risk. Ability to prioritize demands from multiple business clients in a fast-paced environment.Must be a self-starter who works well independently, but knows when to seek input or ask for guidance.Able to allocate time and resources efficiently, focusing on ever-shifting priorities.Able to prioritize conflicting demands from multiple business clients in an extremely fast-paced environment.Embody Crinetics’s core values.Trustworthy, the highest standard of personal and professional integrity and solid ethicsKeen attention to detail and excellent organizational skills.Well written and clear and articulate verbal communication skills to provide advice and guidance in a coherent fashion to colleagues. Exceptional analytical skills: one who sees the big picture as well as the details.Fluency in English and German written and spoken, additional fluency in other European languages highly valued.Travel:You may be required to travel for up to 15% of your time.Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.