Associate Director, Global R&D Compliance Lead

Galderma Laboratories; Boston (MA); On-site; USD 170,000 - 212,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) plan

Paid time off

Other benefits

Job summary

Galderma seeks an Associate Director, Global R&D Compliance Lead to oversee compliance for the R&D organization in Boston, advising on regulatory risk and interacting with global ethics leadership. You will manage training, governance, and ongoing monitoring of the R&D compliance program.

Based in the R&D hub, you will lead internal governance on investigator-initiated studies, clinical funding reviews, and external engagements, ensuring adherence to US and international laws and

Qualifications

• 7+ years advising pharma/biotech/medical device on compliance.
• Strong understanding of healthcare compliance and regulatory frameworks.
• Experience advising R&D teams and on US/international healthcare compliance.
• Experience designing training programs and policy development.

Responsibilities

• Serves as primary compliance contact for R&D organization and Global Medical Affairs.
• Oversees R&D compliance program alignment with regulator expectations and codes.
• Leads funding review committee and manages R&D spend oversight.
• Manages HCP/HCO remuneration processes and FMV considerations.
• Drives governance for IIS, clinical trials, and research funding requests.

Skills

R&D compliance

Regulatory knowledge

Legal education

Healthcare compliance

In-house experience

KOL/Funding compliance

Education

Bachelor's degree

Law degree preferred

Job description

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title

Associate Director, Global R&D Compliance Lead

Job Location

Boston, MA

The Opportunity

The Global R&D Compliance Lead is responsible for leading and managing compliance support to Galderma's global R&D organization, advising on compliance matters and key risk areas within R&D.Serving as the global point contact on all compliance matters to, among others, the Global Head of R&D and Global Head of Medical Affairs, the role will work closely with R&D management as well as members of Galderma's R&D Legal group (and more broadly Galderma's Legal & Compliance function).Reporting to the Global Head of Ethics & Compliance, the role will be based in Galderma's R&D hub in Boston.

Key Responsibilities

• Serves as the primary compliance point of contact for the R&D organization (including Global Medical Affairs).
• Oversees Galderma's compliance program relevant to R&D matters, ensuring alignment with regulator expectations and Galderma's own compliance program, relevant codes of practice and relevant country laws and regulations.
• Serves on, and as the primary compliance contact for, the Global Funding Review Committee (GFRC).
• Manages Galderma's research and consultancy arrangements, in particular with those healthcare practitioners (HCPs) serving as Key Opinion Leaders (KOLs) ensuring visibility and oversight of Galderma' global and in-market spend for such KOLs.
• Ensures compensation and other remuneration provided to HCPs, HCOs, and other covered persons/entities under arrangements are appropriately captured and routed to Galderma's financial transparency processes and systems.
• Manages and serves as the primary interface for Galderma's FMV processes and specific rates.
• Supports and advises on internal governance related to the review and approval of Investigator Initiated Studies (IIS), clinical trial activities and research funding requests.
• Leads and co-ordinates the training of global R&D personnel on R&D-specific compliance policies and procedures.
• Leads and co-ordinates R&D risk & monitoring activities, and related remediation.
• Supports and advises on internal governance related to the review and approval of congress and meeting activities.
• Monitors the regulatory and broader compliance environment to determine the potential impact of regulatory changes on compliance programs as they affect R&D and drive necessary changes to relevant compliance policies and processes.

Qualifications

• Bachelor's Degree required; lawyer qualification strongly preferred.
• 7+ years of experience advising a pharmaceutical, biotechnology or medical device company on compliance matters required, with 3 years of in-house experience preferred.
• Strong understanding of healthcare compliance and broader legal and regulatory framework laws, including regulations and guidance applicable to the pharmaceutical and medical device industries.
• Significant experience advising R&D organization(s) on R&D and related matters.
• Expertise and significant experience advising on U.S. and international healthcare compliance for prescription products and devices, including specifically in respect of R&D activities.
• Deep knowledge of pharmaceutical industry regulations and therapeutic areas, and of the laws, regulations, and industry guidance relevant to the commercialization of pharmaceutical products (including but not limited to the U.S. Federal Anti-Kickback Statute, False Claims Act, Food Drug and Cosmetic Act, OIG and DOJ Guidelines, PhRMA Code, and U.S. state and local marketing compliance laws and relevant government enforcement actions).
• Experience developing, designing, and implementing compliance training programs, developing risk management strategies, and drafting policies and standard operating procedures.

Interpersonal Competencies & Success Factors

• Proven track record of developing, building, and implementing effective compliance programs.
• Strong and proven strategic leadership skills, with executive presence and gravitas.
• Ability to identify and drive improvement and new initiatives throughout the organization.
• Energetic leader with passion for growing a business.
• Solution-oriented, flexible, and agile with the ability to move quickly, pivot when needed, manage multiple priorities, and meet deadlines in a fast-paced work environment.
• Cultural sensitivity and demonstrated success in navigating a large and matrixed global organization.
• Excellent verbal and written communication skills, including outstanding presentation skills, with the ability to deliver clear and concise guidance and instructions.
• Excellent qualitative and quantitative analytical skills to identify and solve a wide range of business problems.
• Ability to interact and partner effectively with senior management and associates at all levels within the organization.
• Ability to implement effective compliance programs alongside business objectives.
• Strong attention to detail and strong organizational skills.
• Ability to effectively manage conflict and other challenging situations.
• Reputation for the highest integrity and ethical standards.

Physical Requirements and Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role. This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.

Compensation

The target base salary range for this role is $169,600,000-$212,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are based on an assessment of the candidate's qualifications and the totality of relevant factors. In addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.

Benefits

• medical coverage
• dental coverage
• vision coverage
• 401(k) plan with employer match
• paid time off
• other benefits

Work Authorization

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

What We Offer

At Galderma, you'll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.