Director - Clinical Operations - Amicus Therapeutics - Cranbury

Job description
The Director, Clinical Operations is responsible for clinical studies, including appropriate planning and rigorous execution of studies with the highest quality data as the final output. Providing input to the overall program’s strategies, the Director of Clinical Project Management ensures effective communication across functional groups, during all stages of the clinical study from protocol design to final CSR, in order to achieve corporate goals on time and on budget.


MAJOR ACTIVITIES AND RESPONSIBILITIES
Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foster growth of staff
Ensure all necessary training is provided to his/her staff to support their job performance and knowledge; remain cognizant of, and remove any barriers or obstacles that impede his/her staff from achieving objectives
Create and oversee project plans to prospectively define workstreams and dependencies, owners, due dates and documentation required as well as to incorporate lessons learned to facilitate achieving key objectives
Manage projects to ensure they are rigorously conducted to produce high-quality data, with adherence with SOPs and appropriate regulations
Liaise with team members (e.g. Science, Regulatory, Drug Supply) regularly to maximize communication of issues, status of tasks
Proactively identify and address key risks; conduct risk/benefit analyses on an ongoing basis
Inform key stakeholders of project status in relation to quality, cost and timelines
Ability and willingness to travel approximately 10% of the time (international and domestic)
Other responsibilities may be assigned as required
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ORGANIZATIONAL STRUCTURE
Reports to Vice-President, Clinical Operations & Data Management

Desired Skills and Experience
QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements
BS or BA required; MS in the biological sciences (e.g. Biochemistry, Pharmacology) preferred; PMP certification highly desired

Professional Work Experience
Minimum of 10 years of experience in clinical development in a pharmaceutical, biotechnology, or CRO setting
Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
Solid scientific background; able to understand biomarkers and clinical endpoints
Excellent command of MS Powerpoint, Word, Excel and Project
Self-motivated and able to function with little supervision
Highly detail-oriented
Excellent interpersonal skills
Superior communication skills, both verbal and written; able to synthesize complex data and ideas and summarize for senior management
Good team player
Able to resolve conflicts in a diplomatic manner
Demonstrated leadership skills
Ability to manage up and down
Good negotiation skills
Solid problem-solving and decision-making skills

Compensation
A competitive compensation package will be presented to the right individual including base salary, bonus, and equity

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