Director, Legal Compliance

Job Description

The Director, Legal and Compliance, serves as a trusted strategic partner and is responsible for providing practical and thoughtful legal counsel to the Commercial, Medical Affairs, Market Access, and Patient Support functions in support of assigned products. This role is the expected to be the subject matter expert on U.S. healthcare laws, FDA promotional regulations, and industry codes to enable compliant launch readiness and ongoing commercialization activities for the assigned product. The role ensures that the Company’s U.S. compliance program remains risk-based, fit-for-purpose, and aligned with corporate values, while supporting cross-functional teams through advisory responsibilities, training, and policy development.

Key Responsibilities

Commercial & Medical Affairs Legal Support (35%)

• Serve as key legal partner and SME to commercial and medical teams on established and launch products
• Provide practical legal advice on launch strategy, disease awareness, marketing campaigns, patient programs, and all other business activities supporting the product

Review Committee Participation (20%)

• Act as Legal representative on Promotional Review Committee, Medical Review Committee, ISR reviews, grants and sponsorships committees for established and launch products

Patient Support & Market Access Compliance (20%)

• Advise patient support team on legal issues related to patient support, hub services, and reimbursement programs
• Counsel market access on PIE, FDAMA 114; draft and review commercial and patient support agreements

Compliance Program Development (10%)

• Advise commercial, medical, and advocacy teams on compliance obligations
• Evolve the U.S. compliance program to remain right‑sized and aligned with company values

Training & Education (5%)

• Prepare and deliver training on compliance responsibilities, ethics, policies, and procedures

Policies & SOPs (5%)

• Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes

Transparency Reporting (3%)

• Support U.S. federal and state transparency reporting and assist business leadership with reporting obligations

Cross-Functional Legal Support (2%)

• Coordinate legal support as a cross-functional partner with business and Law Department colleagues

Other duties and responsibilities as assigned.

Qualifications

Required Qualifications

• Bachelor’s degree required; JD strongly preferred with 12+ years of relevant legal/compliance experience in the biopharmaceutical industry
• Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance, and industry codes.
• Experience providing legal or compliance support to Commercial, Medical Affairs, Market Access, and/or Patient Support functions.
• Experience reviewing promotional and medical materials as a Legal or Compliance reviewer.
• Ability to interpret and apply healthcare laws to complex business activities.

Preferred Capabilities

• Experience in commercial and medical compliance in a pharmaceutical environment.
• Experience supporting product launch planning and cross-functional review committees.
• Strong business partnering orientation with ability to balance risk and business goals.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $191,000 - $236,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.​

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

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