Description:
Job Description: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 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 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
- Advise patient support team on hub services, reimbursement programs
- Counsel market access on PIE, FDAMA 114; draft and review commercial and patient support agreements
- Provide legal advice to commercial, medical, and advocacy teams on compliance obligations
- Support Compliance to evolve the U.S. compliance program to remain right‑sized 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.
- Coordinate legal support as a cross-functional partner with business and Law Department colleague
- Other duties and responsibilities as assigned.
Qualifications:
Required Qualifications:
- Bachelor's 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.
- 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 $167,000 - $230,000. 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)
