Compliance Director, Medical

ABOUT DOMPÉ

Ciao! At  Dompé , our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company.  Founded in Milan, Italy, we have a 130-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States.
 
Today Dompé has over 900 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area.

YOUR ROLE AT  DOMPÉ

The Compliance Director, Medical is responsible for continued development and ongoing management of the U.S. Healthcare Compliance program and is the primary compliance advisor to the Dompé U.S. Medical & Clinical Affairs organizations.  Reporting to the U.S. Compliance Officer, the Compliance Director, Medical serves as a member of the U.S. compliance leadership team, while supporting the Company’s overall U.S. compliance strategy and culture.  The Compliance Director, Medical helps develop and implement Dompé’s ethics and compliance program  and handles related matters at the direction of the U.S. Compliance Officer to promote compliance with the rules and regulations of regulatory agencies, company policies and procedures, and the company’s Healthcare Compliance Program.

Responsibilities:
•    Assist in continued development, refinement, and maintenance of policies and procedures for the general operation of the U.S. Healthcare Compliance program and its related activities to prevent illegal, unethical, or improper conduct.
•    Independently drive the development, implementation and management of the U.S. compliance program, including policy, process, training, communication, programs and systems ;
•    Serve as a Compliance subject matter expert for the U.S. Medical & Research & Development (R&D) teams; 
•    Perform monitoring of Medical & Clinical Affairs activities;
•    Conduct compliance investigations and audits as directed by the U.S. Compliance Officer and develop appropriate responses to investigations and audits, including remedial measures;
•    Develop formal and informal communication tools to deliver compliance program key messages to the company, focusing primarily on the Medical & Clinical Affairs organizations;
•    Ensure the compliance strategy for the U.S. Medical & Clinical Affairs aligns with the broader compliance strategy for the overall U.S. organization;
•    Serve on, and assist the U.S. Compliance Officer in the maintenance of, the US Compliance Committee;
•    Remain current on external ethics and compliance developments and implement responses to these developments which enhance the U.S. ethics and compliance program, including communication of those developments to the U.S. Medical & Clinical Affairs organizations;
•    Track compliance metrics and provides reports on a regular basis and as directed or requested; assists the U.S. Compliance Officer with reports to management regarding the operations and progress of compliance efforts;

•    Collaborate with other Compliance colleagues and members of the U.S. Medical & Clinical Affairs organizations to embed ethics and compliance as a part of the way employees work at Dompé. 

Requirements/Qualifications:
•    Bachelor’s degree required; relevant advanced (i.e: JD) degree preferred;
•    Minimum of 10  years of experience in a pharmaceutical or biotech organization with at least 5 years in a  compliance function;
•    Strong understanding of state and Federal healthcare laws and regulations as well as industry-related codes;
•    Small company experience with focus on commercial and medical affairs activities is required;
•    Teamwork-focused, with strong interpersonal and management skills;
•    Demonstrated ability to analyze and assess business and regulatory information and effectively communicate at all levels of the organization;
•    Self-starter with demonstrated results;
•    Able to manage many tasks effectively and deliver on deadlines;
•    Strong customer service orientation.
•    Strong working knowledge of Microsoft 360, including PowerPoint, Excel. Creating professional presentations for the Compliance Team and Executive Leadership Reporting a plus.

BENEFITS OF JOINING OUR TEAM
•    Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees

•    Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle
•    Competitive 401(K) matching
•    Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train
•    A super cool team who’s excited to transform lives through innovative therapies

Location: This is a hybrid role with an expectation of 2-3 days onsite in our San Mateo office. 

$200,000 - $235,000 a year

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.