Director of Project Management (Pharma)

About Proposals & Contracts at Clinigen:

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

This position maintains and enhances the US Project Management Department through strategic planning, evaluating workload over different sites and team members.  Ensure that objectives are achieved in accordance with established budgets and customers satisfaction.  Standardize practices and procedures across the US and EU locations to be able to shift work and resources and gain efficiencies over the different sites.  Manage resources to deliver customers on-time.

This role will be hybrid with 3 days onsite presence required 2 days remote.

To be successful in this role you should have:

Bachelor's Degree

4+ Years of previous management experience

8+years of work experience related to the knowledge of principles and practices involved in cGMP and Clinical Trial Management or any equivalent combination of education, training and/or experience

Possess a detailed proactive approach to management in problem solving of daily operations

Your role at Clinigen :

Coordinate with the Business Development team client contract creation specifications

Oversee the Project Managers as needed with managing the project design and implementation structure of clinical studies including, but not limited to, packaging and labeling, dispensing, and distribution of clinical trial material and ancillary supplies.

Oversee Project Managers in the creation, review and approval of processing documents and schedules, while adhering to client specific needs and timelines. Ensure accurate billing and documentation of project planning hours and activities

Acts as a liaison between clients and CSM and travels as needed to client locations

Partner with other team members in Operations to maintain and track outstanding requests

Work closely with the US Team Leads to ensure consistency is maintained and identify areas for improvement

Work closely with EU Project Management Director/Team Leads to ensure Project Management Processes are harmonized

Work closely with EU Project Management Team to address any issues that may arise

Delegate, provide instruction, train and provide oversight to direct reports

Partner with Quality Assurance to develop or revise SOPs, Work Instructions and Processing Protocols

We’re excited about you if you have:

Ability to lead, coach and mentor employees to provide direction in resolving issues

Must possess a detailed proactive approach to management in problem solving of daily operations

Exceptional oral and written communication skills and active listening ability

Excellent time management skills and ability to adapt quickly in a fast paced, changing environment

Self-motivated learner with demonstrated ability to take initiative and evaluate situations to find solutions

Confidentiality of all clients’ proprietary and pharmaceutical related information is essential