Associate Director, Legal Compliance

The Associate Director Legal Compliance serves as a trusted strategic partner to the Commercial Medical Affairs Market Access and Patient Support functions. This role provides subject matter expertise 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 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 Compliance Support for Launched Product and Pre-Launch Preparation (55%)

• Serve as trusted business partner and SME to commercial and medical teams
• Advise on launch strategy disease awareness marketing campaigns patient programs
• Act as Legal representative on Promotional Review Committee Medical Review Committee ISR reviews grants and sponsorships committees

Patient Support & Market Access Compliance (20%)

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

Support Compliance Program Development (20%)

• Provide legal advice to commercial medical and advocacy teams on compliance obligations
• Support 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 (5%)

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

Other duties and responsibilities as assigned.

Qualifications :

Required Qualifications

• Bachelors and JD required.
• A minimum of 10 years of relevant legal/compliance experience. Biotechnology experience strongly preferred.
• 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 $167000 - $230000. 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.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

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