Senior Director, Compliance

Revolution Medicines; San Francisco (CA); On-site; USD 250,000 - 300,000; Full time

Job summary

Join a forward-thinking clinical-stage oncology company dedicated to developing targeted therapies for RAS-addicted cancers. In this pivotal role, you will provide legal counsel across various departments, ensuring compliance with complex regulations and laws. Your expertise will help shape compliance strategies and drive initiatives that impact patient care and safety. This position offers the chance to work with a dynamic team, where your contributions will directly support the mission of improving outcomes for patients battling cancer. If you have a passion for legal compliance in the healthcare sector, this opportunity is perfect for you.

Qualifications

• Minimum 13 years of relevant experience in legal compliance.
• Strong knowledge of FDA regulations and healthcare compliance.

Responsibilities

• Design and drive compliance programs and manage investigations.
• Provide legal counsel on policies and procedures for compliance.
• Collaborate with teams to ensure accuracy and compliance of materials.

Skills

Excellent written and verbal communication skills

Strong collaborative skills

Strong organization and time management skills

Knowledge of legal and regulatory requirements

Ability to work independently and collaboratively

Analytical skills

Education

Law degree from an ABA accredited law school

Job description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The individual will serve as counsel for a diverse set of clients across the company, frequently interacting with and providing substantive advice to Commercial, Marketing, Regulatory Affairs, and other departments concerning a broad range of legal, regulatory, and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, relevant industry codes, the Sunshine Act, and the Prescription Drug Marketing Act, among others. This position reports to the Vice President, Legal Compliance.

1. Design, employ, and drive compliance programs, manage investigations, and train employees.
2. Serve as legal reviewer on promotional and medical review committees, working cross-functionally with commercial, regulatory, and medical affairs to help ensure consistency, accuracy, and compliance of materials for promotional, medical affairs, market research, advisory boards, and training.
3. Assist with functional teams to review internal and external communications such as social media posts, corporate presentations/webinars, and press releases.
4. Provide legal counsel on relevant policies, procedures, and training to ensure company compliance with policies, state and federal laws and regulations.
5. Collaborate with department leaders to understand risk considerations, implement compliance-related policies, and support ongoing compliance initiatives.
6. Update risk assessments and develop risk mitigation strategies and methods to operationalize compliance.
7. Establish strong relationships with key internal stakeholders to understand current and future compliance needs relating to reporting.
8. Manage compliance investigations.
9. Develop and manage an effective compliance communication program for the organization, including promoting the use of the compliance hotline, heightened awareness of the Code of Conduct, and applicable compliance policies.
10. Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program.
11. Research, draft, and update corporate compliance policies and standard operating procedures.
12. Resolve routine legal matters in the practice area with direct supervision as needed.
13. Assist with the review and negotiation of agreements that may impact healthcare compliance.
14. Help select and direct the work of outside counsel, define project objectives, and manage projects.
15. Train new employees in company standard operating procedures and compliance, and update and create additional training content.
16. Participate in CMS, state, or health plan audits and reviews.
17. Gather and audit data, prepare, and validate the federal and state transparency reports such as the Sunshine Act.

Required Skills, Experience and Education:

1. Law degree from an ABA accredited law school and in good standing with the state bar of the jurisdiction.
2. Minimum of 13 years of relevant experience.
3. Excellent written and verbal communication skills, including the ability to communicate complex legal issues in a simple, understandable manner.
4. Strong collaborative skills, able to build partnerships internally and with external partners.
5. Strong organization and time management skills with flexibility, creativity, and resourcefulness.
6. Knowledge of legal and regulatory requirements related to consumer privacy, data protection, health information privacy (HIPAA), and other relevant laws.
7. Demonstrated ability to independently identify, analyze, and render legal advice on complex business issues.
8. Ability to work both independently and collaboratively.

Preferred Skills:

• Experience with pharmaceutical/biotech companies required; educational background in an applicable scientific field is a plus.

The base salary range for this full-time position is $250,000 to $300,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite and will be adjusted for the local market a candidate is based in.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.