Nature and Scope

Able to manage teams and program toward the approval of new pharmaceuticals agents/ indications.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Responsible for cross-functional team delivery of project milestones, within budget and timelines
• Responsible for communication within the company and with outside vendors (e.g., CROs)
• Participates in the preparation of project level and study level management plans and risk mitigation plans and ensures that project teams and study teams comply with plans and SOPs
• Manages the risk management plans and is responsible for risk mitigation activities
• Ensures that proper training is provided to the clinical study teams, coordinates the planning if investigators meetings and training of internal personnel assigned to studies within the project
• Participates in the evaluation, selection, and budgeting process of CROs and other vendors at project level and study level
• Coordinates and manages CROs activities and performance according to project and study plans
• In collaboration with the Medical Director and cross-functional departments, assigns personnel to study teams
• Perform any other tasks/duties as assigned by management.

Other Responsibilities:

• Perform any other tasks/duties as assigned by management.
• We all must embrace the QUALITY culture.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelors' degree in the Biological, Health Sciences or related field required.
• Minimum of 5 years pharmaceutical industry experience required. 5 years having held the position of Clinical Project Manager in a pharmaceutical/ biotech or CRO company, managing phase 2 and 3 clinical trials preferred.
• Understanding of ICH-GCP and a thorough comprehension of the drug development process.
• Clinical trial regulations, such as those of the US FDA, EMEA, DCGI, and others, are well-understood.
• Ability to multi-task and successfully handle multiple priorities simultaneously.

Expected Salary Range:

$115,500- $130,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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