Director, Product Counsel

The Director Product Counsel 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 and medical activities for the assigned product. The role partners with Compliance to ensures that the Companys 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 (75%)

• Serve as key legal partner and SME to commercial and medical teams on established and launching products
• Provide practical legal advice on launch strategy disease awareness marketing campaigns patient programs advisory boards and all other business activities supporting the assigned products
• Act as Legal representative on Promotional Review Committee Medical Review Committee ISR reviews grants and sponsorships committees for established and launch products
• Counsel market access on pricing reimbursement distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub services

Compliance Program Support (15%)

• Advise commercial medical and advocacy teams on compliance obligations
• Partner with Compliance to evolve the U.S. compliance program to remain rightsized and aligned with company values
• Prepare and deliver training on compliance responsibilities ethics policies and procedures
• Support development and enhancement of compliance policies and SOPs related to AKS FCA and industry codes

Cross-Functional Legal Support (10%)

• Coordinate legal support as a cross-functional partner with business and Legal and Compliance colleagues

Other duties and responsibilities as assigned.

Qualifications :

Required Qualifications

• JD required 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 $191000 - $236000. 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 Decipheras 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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EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially.  We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Remote Work :

No

Employment Type :

Full-time