Executive Director, Clinical Research

Amicus Therapeutics, Inc.; Princeton (NJ); On-site; USD 275,000 - 320,000; Full time

Benefits offered by this job

Health insurance

Retirement plan (401K)

Performance-based bonuses

Stock options

Paid time off

Job summary

A biopharmaceutical company is seeking an experienced leader for clinical development who can oversee clinical trial protocols and ensure high-quality execution. Candidates must hold an M.D. degree and have at least 8 years of experience in the industry, preferably in drug development related to rare diseases. The role offers a competitive salary range of $275,000 to $320,000 and various employee benefits.

Qualifications

• Minimum of 8 years’ industry experience preferred, but exceptional candidates with less will be considered.
• Experience in a major pharmaceutical or biotechnology company.
• Demonstrated experience in NDA/BLAs or MAAs submission process.

Responsibilities

• Lead clinical development strategy and CDP preparation.
• Oversee clinical trial protocols and ensure high-quality study execution.
• Collaborate with Clinical Trial Investigators and organizations.

Skills

Drug development expertise

Project management

Strong oral and written communication

Interpersonal skills

Team player

Flexibility and adaptability

Education

M.D. degree or equivalent medical qualification

Job description

Overview

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.

Roles and Responsibilities

• Lead the clinical development strategy and the Clinical Development Plan ("CDP") preparation for clinical programs and clinical trial protocols.
• Responsible for assets from early phase through to registration and the approval process.
• 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.
• Work with Clinical Trial Investigators and Clinical Research Organizations to collaborate on trial site selection, training and ongoing conduct of the study.
• 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.
• Successfully interact with experts and other external partners in a manner consistent with Amicus’ beliefs.
• Participate in preparation of regulatory documents (e.g., Investigator Brochures, CSRs, Briefing documents) and in face-to-face meetings with the regulatory agencies.
• Maintain highest level of medical science and clinical development expertise in Amicus’ fields of interest.
• Collaborate on business development activities.
• Perform all responsibilities in compliance with company policies, SOPs and guidelines.
• Represent Clinical Research function on Program-aligned governance and operational committees and corporate projects/initiatives as required.

Educational Requirements

• M.D. degree (or equivalent medical qualification). 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

• 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.
• 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%)

Compensation and Benefit Summary

• The U.S. base salary range for this full-time position is between $275,000 and $320,000 year. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. In addition to the base salary, employees may be eligible for various benefits, including health insurance, retirement plan (401K), paid time off, performance-based bonuses, stock options, restricted stock units, and other discretionary awards. Details of participation in these benefit plans will be provided during the hiring process.

We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard.

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.