Director, Legal Compliance

Deciphera Pharmaceuticals; Waltham (MA); On-site; USD 191,000 - 236,000; Full time

Benefits offered by this job

Competitive salary and annual bonus

Comprehensive benefits package including medical, dental, vision insurance

Generous parental leave and family planning benefits

Outstanding culture and opportunities for personal and professional growth

Job summary

A biopharmaceutical company in Waltham, Massachusetts is seeking a Director of Legal and Compliance. This role involves providing legal counsel to teams in various functions while ensuring compliance with U.S. healthcare laws. Candidates must possess a JD and over 12 years of experience in legal/compliance within the biopharmaceutical industry. The position offers an estimated salary range of $191,000 to $236,000, along with comprehensive benefits and an annual performance bonus.

Qualifications

• 12+ years of relevant legal/compliance experience in the biopharmaceutical industry.
• Deep knowledge of FDA promotional regulations and industry codes.
• Experience providing legal support to Commercial, Medical Affairs, Market Access, and Patient Support functions.

Responsibilities

• Serve as key legal partner and SME to commercial and medical teams.
• Advise patient support team on legal issues related to patient support.
• Advise commercial, medical, and advocacy teams on compliance obligations.

Skills

FDA promotional regulations

Anti-Kickback Statute

False Claims Act

Legal/Compliance support

Strong communication skills

Education

JD Degree

Job description

Overview

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 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

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 $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

Apply Today

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. Providing this information is optional and will not affect your opportunity for employment. This information will be treated confidentially. We are committed to making all hiring decisions on a non-discriminatory basis.