Vice President of Clinical Research

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary:

The Vice President of  Global Drug Safety reports to the SVP clin dev and safety pharmacovigilance and safety surveillance functions for both investigational and commercialized products. This individual will be responsible for setting strategy, ensuring compliance, and driving innovation within  safety across the company's portfolio. The role requires strong leadership in advancing clinical ensuring the highest standards of patient safety and regulatory compliance.

This role is critical in ensuring the success of the company's clinical development programs while safeguarding the safety of patients globally. The Vice President of Global Drug Safety will be a key member of the company's governance leadership team, contributing to the company's long-term growth and innovation.

Roles and Responsibilities: 

Global Drug Safety Management

·       Lead the pharmacovigilance and drug safety strategy for investigational and marketed products.

·       Establish and maintain a comprehensive safety surveillance system to detect, assess, and report adverse events.

·       Ensure compliance with global regulatory requirements (FDA, EMA, etc.) and guidelines (ICH, GCP) related to clinical safety.

·       Provide safety assessments for clinical development, risk management plans, and post-marketing surveillance.

·       Serve as the primary contact for regulatory authorities on safety issues and risk management strategies.

·       Support GVP audit and inspection preparedness

Team Leadership & Development:

· Build, mentor, and lead high-performing teams in  drug safety.

· Foster a collaborative environment that encourages innovative thinking and best practices.

· Partner with senior leadership to drive organizational growth and support company-wide strategic initiatives.

· Represent the company at key scientific, regulatory, and industry events to enhance external visibility and partnerships.

Regulatory & Compliance:

· Ensure  safety activities are conducted in full compliance with local and international regulations.

· Collaborate with regulatory affairs on submissions, safety reports, and labelling for both investigational and commercial products.

· Maintain up-to-date knowledge of regulatory changes, industry trends, and scientific advancements affecting drug safety and clinical development.

Risk Management & Decision-Making:

· Provide expert clinical and safety risk assessments to support product development, regulatory filings, and commercial activities.

· Implement risk mitigation strategies for safety concerns that arise during clinical trials or post-approval.

· Critical leadership role in company governance forums related to safety, labelling, and clinical development strategy.

· Work closely with internal stakeholders to make informed, data-driven decisions on the progression of clinical programs.

Business Development & Asset Due Diligence

· Support business development teams by providing safety expertise during the evaluation of potential in-licensing, co-development, or acquisition opportunities.

· Conduct in-depth due diligence on new assets, including  assessing safety profiles, and evaluating regulatory pathways.

· Collaborate with internal teams and external partners to identify potential risks and opportunities associated with new assets.

Requirements

Educational Requirements

·       MD (or equivalent) in a related scientific or clinical discipline.

· years of experience in clinical development and drug safety within the biopharmaceutical industry.

Professional Work Experience Requirements

·       Experience with both small molecule and biologics development.

·       Expertise in rare diseases (preferred) or another specialized therapeutic area.

·       Global experience working across different regulatory regions (e.g., North America, Europe, Asia).

Experience and Skills

·       Deep understanding of global regulatory requirements and safety standards (e.g., FDA, EMA, ICH).

·       Experience managing cross-functional teams and external partnerships, including CROs and key opinion leaders.

·       Strong leadership, communication, and decision-making skills with the ability to navigate complex, fast-paced environments.

·       Strategic thinker with the ability to drive clinical innovation and foster a culture of excellence.

Other skills/Attributes

·       Demonstrated alignment with Amicus Mission Focus Behaviors

·       Passion for rare disease and patient focused

·       Leadership & People Management

·       Strategic Thinking

·       Innovation & Problem Solving

·       Regulatory & Compliance Expertise

·       Effective Communication

·       Collaboration & Cross-functional Partnership

Travel

·       Up to 20%

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.  Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.  Our "Three Pillars of DEI" are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.