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Galderma

Associate Director, Global R&D Compliance Lead

Posted 3 Days Ago
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In-Office
Boston, MA, USA
212K-170M Annually
Senior level
In-Office
Boston, MA, USA
212K-170M Annually
Senior level
Leads global R&D compliance for Galderma, advising R&D and Medical Affairs leadership on healthcare regulations, risk areas, research funding, HCP and KOL arrangements, fair-market-value processes, transparency reporting, clinical research governance, training, monitoring, remediation, and congress activities. The role develops compliance policies and programs, evaluates regulatory changes, and partners with Legal and Compliance teams across a global, matrixed organization.
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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 made 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

Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and other benefits, subject to eligibility and applicable plan terms.

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.

Next Steps

  • If your profile is a match, we will invite you for a first virtual conversation with the recruiter. 

  • The next step is a virtual conversation with the hiring manager  

  • The final step is a panel conversation with the extended team 

Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!

If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers. Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.

Galderma Boston, Massachusetts, USA Office

Boston, United States

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