Director of Regulatory Affairs - (US-IL-Galesburg - 61402)

Compensation: $140K - $180K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: 2930
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Our client is a rapidly growing, development-stage pharmaceutical company that is focused on the commercialization of therapeutics for patients with unmet needs that are suffering from chronic kidney disease. With offices in Canada and the US, the company boasts a world-class management team with unparalleled expertise in this area, a varied selection of cutting-edge protocols and an empowering corporate culture that is focused on the long-term professional development of its employees.

Job Responsibilities:
1) Devise, implement and manage clinical operations of multiple pharmaceutical products over all phases of development
2) Allocate resources appropriately
3) Manage and ensure adherence to project costs and timelines
4) Mentor and motivate departmental and cross-functional employees
5) Contribute toward proactively formulating global clinical development strategies that successfully execute the company’s core business of pharmaceutical development
6) Prepare clinical development timelines and budgets within multidisciplinary project teams to ensure timely submissions aligned with company objectives
7) Coordinate, facilitate and construct study designs and protocol as well as appropriate study monitoring and conduct within cGCPs, consistent with the requirements for regulatory filings
8) Develop, interact with and manage internal employees as well as external CROs and CMOs to ensure timely and cGCP compliant activities to achieve clinical project successes
9) Participate in regulatory submission process including INDs, CTAs, CTDs, NDAs and provide appropriate clinical updates to those documents
10) Ensure that all documents submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality so as to facilitate review
11) Serve as the principal spokesperson for clinical development and communicate clinical development status to senior management
12) Build and maintain good business as well as working relationships with internal and external groups
13) Participate in analysis and reviewing of data
14) Review, edit and contribute to the construction of clinical documents (study protocols and reports, ICFs, CRFs and publications) to ensure cGCP compliance and accurate presentation of data
15) Participate in the selection and maintenance of study investigators and clinical sites
16) Communicate openly and effectively
17) Work to develop a team-based approach
18) Lead and motivate regulatory as well as compliance activities
19) Assist senior management to formulate as well as establish company policies and operating procedures (SOPs)
20) Ensure staff attains a level of quality applicable to the quality system and applicable professional standards

Job Requirements:
1) BS in Biological or Chemical Sciences (Advanced degree preferred)
2) 5 – 10 years of pharmaceutical industry clinical development experience
3) Experience in supporting product approvals and renewals, post-marketing activities as well as interacting with principle investigators and key opinion leaders
4) Experience in clinical trial methodology, cGCPs (as per FDA and ICH guidelines), strategic clinical trial planning and operation along with comprehensive planning and management of project budgets
5) Minimum 2 years of people and project-management experience
6) Knowledge of bio-statistics and data management a plus
7) Superb interpersonal skills
8) Excellent verbal and presentation skills
9) Detail-oriented with good organizational, time-management and leadership skills
10) Familiarity with conduct of clinical research in a regulated environment
11) Ability to work independently and as a functional leader
12) Ability to work in a team environment
13) Willingness to travel within the US and internationally (up to 20%)

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02930.html