What are the responsibilities and job description for the Executive Director Clinical Research position at AMICUS?
Executive Director 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 Executive Director Clinical Research will be responsible for all phases of Clinical Development from the continued development of marketed product(s) as well as assets in early development. The incumbent will be responsible for leading the generation of the clinical development plans and the clinical trial protocols that will lead to successful submissions of novel treatments. This individual may also have significant early-on interaction with clinical/preclinical teams and will collaborate with other functions in the Development Organization and across Amicus Therapeutics to optimize the strategy and to plan, implement, execute, analyze and report the clinical studies, culminating in global regulatory submissions.
Roles and Responsibilities
1. Lead the clinical development strategy and the Clinical Development Plan (“CDP”) preparation for clinical programs and clinical trial protocols.
2. Responsible for assets from early phase through to registration and the approval process.
3. Play a significant leadership role with the potential to oversee junior member(s) of the clinical team, as well as providing hands on tactical work, in project teams and working in collaboration with relevant team members and peers, to ensure the highest level of execution for clinical programs.
4. Work with Clinical Trial Investigators and Clinical Research Organizations to collaborate on trial site selection, training and ongoing conduct of the study.
5. Ensure that studies are performed with the highest quality. Perform data review and analysis, presentations (oral and written) of clinical data, and lead the generation of clinical study reports.
6. Successfully interact with experts and other external partners in a manner consistent with Amicus’ beliefs.
7. Participate in preparation of regulatory documents (e.g. Investigator Brochures, CSRs, Briefing documents) and in face-to-face meetings with the regulatory agencies.
8. Maintain highest level of medical science and clinical development expertise in Amicus’ fields of interest.
9. Collaborate on business development activities
10. Perform all responsibilities in compliance with company policies, SOP and guidelines.
11. Share, within the Development Organization and the Company, his/her knowledge and expertise in drug development to broaden and update the current level of awareness and practice in the field.
Requirements
Educational Requirements
• M.D. degree. Post residency training is preferred.
Professional Work Experience Requirements
• A minimum of 8 years’ industry experience is preferable, though consideration will be given to exceptional candidates with less time in industry.
Experience and Skills
• Completion of a residency, preferably in either pediatrics or internal medicine and, ideally, a fellowship in a related subspecialties area (e.g., neurology, gastroenterology, genetics, immunology, etc).
• A drug development professional with experience derived from a career in a major pharmaceutical company, or in a biotechnology or biopharmaceutical company environment, including, preferably, a key role in the submission of successful NDA/BLAs and/or MAAs. The ideal candidate will have experience spanning the phases of drug development, preferably from proof- of concept studies to medical affairs.
• Experience with rare and orphan diseases or knowledge of lysosomal storage disorders is not requisite, but is a plus.
• Experience on teams with early and late stage development products.
• Desire and ability to work in a fast-paced, mission-driven environment.
• Strong project management skills; the ability to oversee multiple, complex programs.
• Flexibility and adaptability; ability to thrive successfully in a small biotechnology company environment.
• Excellent oral and written communication skills.
• Clear alignment with Amicus values and culture. Strong interpersonal skills, a collaborative team player who is open minded to the diverse opinions of others.
• Clear alignment with Amicus values and culture.
• Ability to produce highest quality and timely clinical development work product/ documents with limited direction.
• Hands-on performer, ensuring strong execution of clinical trials and other drug development activities.
• A strong sense of personal and professional ethics.
• A good balance of confidence and humility.
• Must be passionate about developing treatments for patients with rare/orphan diseases.
Other skills/Attributes
• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused
Travel
• Ability to travel, both domestic and international (± 25%).
Location
• Preferred location is Princeton, NJ (with a hybrid work approach)
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.
#LI-HYBRID
