Description:
Position Summary:We are seeking an experienced Director, Commercial Counsel to support our mission to develop and commercialize transformative therapies for patients with rare diseases. This role reports to the Vice President - Legal and requires a balance of market acumen, strategic thinking and hands-on execution. This position will play a key role in providing comprehensive legal support across our marketing and commercial programs.
As a member of the Legal team in a dynamic, high-growth biopharmaceutical organization (~400 employees worldwide), you will partner closely with internal stakeholders and outside counsel to provide practical, business-focused legal guidance while mitigating risk.
Job Functions/Responsibilities
- Support the company's commercial organization, including promotional material review, commercial effort/program risk assessment, and providing counsel and guidance on advertising, promotional, sales and marketing assessments.
- Draft, review, and negotiate a broad range of commercial agreements, including grants and corporate giving, license, payor/government pricing and commercial enablement.
- Help maintain and enhance commercial policies, procedures, and internal controls.
- Provide legal support for commercial growth activities, including named patient programs and distribution efforts.
- Partner cross-functionally with Commercial, Regulatory, Finance, and HR teams to structure and negotiate agreements aligned with commercial objectives.
- Identify and mitigate legal risks while providing guidance on FDA and OIG regulations and industry codes.
- Advise on healthcare, regulatory, and compliance matters relevant to a biopharmaceutical company, including promotional review, transparency laws, and interactions with healthcare professionals/patient advocacy groups.
- Support development and implementation of Patient and Healthcare Providers interaction policies and training initiatives.
- Assist in managing internal investigations and responding to regulatory inquiries, as needed.
- Contribute to risk assessments and mitigation strategies across the organization.
- Help manage outside vendor relationships with attention to adherence to industry transparency codes, quality, efficiency, and cost management.
- Help enforce and train on company-wide understanding of privacy laws and regulations as it relates to Company's commercial footprint, such as the GDPR and CCPA, and assist the VP-Legal with monitoring regulatory changes, industry trends, and emerging technologies.
- Advise the organization on how to comply with privacy laws and regulations, including best practices for data collection, storage, and sharing.
- Serve as a trusted legal advisor to internal stakeholders across departments.
- Provide timely, practical, and solutions-oriented legal advice across a broad range of commercial, corporate, and operational matters.
- Develop scalable legal processes appropriate for a growing global organization.
- Promote a culture of integrity, accountability, and compliance.
Qualifications:
Education /Experience:
- J.D. and licensed to practice law in at least one U.S. jurisdiction (active and in good standing).
- 6+ years of relevant legal experience, including meaningful in-house and/or law firm experience supporting life sciences or biopharmaceutical companies.
- Strong understanding of healthcare regulatory and compliance frameworks that apply to commercial biopharmaceutical companies.
- Experience drafting and negotiating complex commercial agreements.
- Understanding of privacy laws and regulations preferred but not required.
- Excellent written and oral communication skills, with the ability to translate complex legal concepts into clear, practical guidance.
- Keen to embrace and understand all areas of the law relevant to the in-house practice of a pharmaceutical lawyer
- Strong commercial acumen, legal drafting skills, and presentation skills
- An ability to work as a member of an international team
Knowledge, Skills, and Abilities:
- Passion for advancing therapies for patients with serious, underserved rare diseases.
- Strategic thinker who is comfortable operating in a hands-on capacity within a growing organization.
- Collaborative and approachable, with the ability to work effectively across functions in a fast-paced, global environment.
- Sound judgment and a solutions-oriented mindset.
- Professional presence with the ability to influence without direct authority.
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