Executive Director, Clinical Research chez Amicustherapeutics

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.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

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, SOP 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.

Postuler maintenant