Senior Director, Legal & Compliance, OUS Regions

Free resume; München; On-site; EUR 140,000 - 230,000; Full time

Job summary

Corcept Therapeutics is seeking a Senior Director, Legal & Compliance, OUS Regions to lead legal and compliance for operations outside the United States, with focus on the EEA, Switzerland and the United Kingdom. You will guide regulatory submissions, contract negotiations, and governance across OUS affiliates.

This role reports to the VP, Legal & Compliance and entails partnering with business teams to mitigate compliance risks while enabling strategic opportunities in pharmaceuticals.

Qualifications

• Professional legal qualification in a European jurisdiction.
• Extensive experience with laws in the EEA, UK and Switzerland for pharma development and commercialization.
• Strong contract drafting and negotiation skills.
• Excellent written and verbal communication.

Responsibilities

• Provide legal advice regarding product sales, promotion and scientific communication in the EEA, UK and Switzerland.
• Advise regulatory submissions and scientific communications with EMA and country authorities.
• Oversee corporate governance records and registrations for all OUS affiliates.
• Design, implement and oversee the OUS compliance program and training.
• Draft and negotiate contracts with healthcare providers, vendors, and data partners.
• Manage external counsel engagement and budgeting.

Skills

Regulatory compliance

Contract drafting

Strategic partnership

Communication

Influencing

Problem solving

Education

Professional legal qualification in a European jurisdiction

Job description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com .

Reporting to the VP, Legal & Compliance, the Senior Director, Legal & Compliance, OUS Regions will serve as lead legal counsel for Corcept's burgeoning operations outside the United States, with particular focus on the European Economic Area, Switzerland and the United Kingdom. This role will provide legal and compliance guidance for a broad scope of legal issues and clients in support of Corcept's business opportunities across all existing and emerging therapeutic areas and will lead the development and coordination of OUS compliance policies and training as part of the company's overall compliance program. The successful candidate will partner with business teams in achieving critical objectives while mitigating the potential impact of compliance risks. This role guarantees exposure to all aspects of Corcept's OUS business.

Responsibilities

• Legal advice regarding product Sales, Promotion and Scientific Communication - Provide practical and timely advice, training and solutions regarding compliance with laws related to all aspects of Corcept's business operations primarily in the EEA, Switzerland and the United Kingdom, including those related to interactions with healthcare professionals, patients and health authorities; market access, reimbursement and government pricing regulation; product distribution, sales and promotion; and data privacy.
• Advise regulatory, medical affairs, and other teams on EMA and country-specific regulatory submissions and scientific communications
• Affiliate Corporate Governance - Oversee maintenance of corporate governance records and registrations for all OUS affiliates
• Compliance, Policy Development and Training - Design, implement and oversee the OUS compliance program, including development and implementation of policies, resources, and training to drive comprehensive, functional knowledge among OUS business teams regarding conduct in accordance with the law and ethical standards
• Contract Drafting and Negotiations - Support negotiation of contractual arrangements encompassing a wide array of third parties, including healthcare providers and vendors of services, products and data, to ensure appropriate protection of Corcept's business opportunities, assets, confidential information and intellectual property colleagues to coordinate legal and compliance guidance for teams operating in OUS jurisdictions
• External counsel engagement - Develop a trusted network of external legal advisors and established frameworks for engagement, coordination, budgeting and oversight

Necessary Skills, Qualifications or Technical Proficiencies

• Professional legal qualification in a European jurisdiction
• Comprehensive knowledge of and compliance experience with laws in the EEA, the UK and Switzerland regarding development and commercialization of pharmaceuticals
• Complex contract drafting and negotiations skills
• Excellent written and verbal communication skills
• Ability to operate as a strategic partner and provide timely and practical legal advice
• High emotional intelligence, capable of collaboratively influencing decision-making through the respectful exchange of competing ideas and perspectives
• Self-driven to identify and solve complex and challenging problems

Required Education and Experience

12+ years of legal practic