919-797-1146 info@aimmaxrx.com

Director/Sr. Director, Clinical Operations & Project Manager

Do you want to make a difference?  Become a key member of AimMax’s team.

We are in immediate need for a Director/Sr. Director, Clinical Operations & Project Management.

The Director/Sr. Director of Clinical Operations and Project Management is a key member of the AimMax drug development team who will be responsible for (i) oversight of the clinical operations of clinical studies of  pharmaceutical or biotechnology products under research and development by the Company, (ii) clinical development activities including but not limited to planning, conduct, data collection, analysis and reporting of clinical studies, (iii) developing, maintaining and tracking R&D project plans and timelines, and (iv) developing and maintaining contracts and budgets, as needed, to support the Company’s product development activities.  In these roles, the Director/Sr. Director of Clinical Operations and Project Management will work cross-functionally within a matrix environment to ensure that the activities supporting the Company’s R&D are of the highest quality, while staying within agreed timelines, budget and scope.

 

Education and Experience                              Qualifications and Required Experience

  • BSN, MS, PhD or PharmD, or equivalent. Advanced degree candidates preferred
  • A minimum of 10 years’ experience in the pharmaceutical industry, with minimum 5-8 years clinical development/clinical operations/project management experience supporting drug development projects.
  • A demonstrated track record of success in clinical development/clinical operations/project management and in leading, coordinating and developing professional staff in a project-led environment.
  • Requires thorough understanding of the drug development process from pre-IND phase through NDA and post-marketing phase.

 

Key Responsibilities

  • Lead and manage clinical operations, interface with data management and biostatistics.
  • Oversee programs and projects, participate in strategic planning and lead implementation or improvement of systems and processes.
  • Develop strategies and manage budgets and timelines to ensure effective achievement of scientific/business objectives. Build contingencies in project or development plans to provide flexibility. Track deliverables to meet milestones, coordinate meetings, track metrics, document meeting minutes. Prepare project timelines that contain all activities, resources and costs to accomplish key milestone dates for integration into the project schedule, providing updates on progress against project objectives, milestones, timelines and metrics.
  • Oversee and manage clinical operations/project management personnel as well as contract research organizations (CROs). Oversee CROs to ensure timely recruitment, quality performance, and budget control.
  • Manage internal SOPs and ensure GCP and regulatory compliance.
  • Support recruitment, supervision and development of clinical staff and ensure that available resources are balanced with contractual obligations and Company objectives.
  • Support Company business development activities including, but not limited to, maintaining and developing external relationships with CROs and KOLs.

 

Qualifications and Attributes

  • Exceptional analytical, organizational skills, time management, great attention to detail.
  • Strong clinical trial experience and drug development knowledge with a demonstrated track record of success.
  • Able to identify and select vendors, develop proposals and conduct and evaluate bid defenses for all aspects of clinical trials.  Develop and negotiate contracts and manage budgets with vendors.
  • Take initiative to identify gaps and drive solutions.
  • Expertise in clinical project operations and management of Phases I – III global clinical trials.  Proven experience leading functions and developing and implementing strategy.
  • Strong operational manager with the ability to multitask productively.  Applies time management processes and procedures effectively.
  • Start-up company experience and entrepreneurial spirit an advantage.
  • Able to contribute to scientific, project and business discussions, and support regulatory activities and documentation.
  • Able to work in a matrix-based cross-functional team with vision, integrity, dedication and flexibility.  Willingness to jump in to help accomplish tasks.
  • Self-motivated, self-learner, agile, can-do approach.
  • Outstanding oral, interpersonal and written communication skills. High capability to effectively communicate with team members and vendors both orally and in writing is a must.  Speaks, writes, listens and presents information in a logical and articulate manner.
  • Proficient in use of MS Office (Word, Excel, Project, PowerPoint, Outlook), and other relevant software.

 

Seniority Level

 Director or Senior Director depending on experience

Travel

 Averaging 10%

Principals Only:  No Recruiters

Salary and Other Compensation:  Commensurate with experience

Contact Info:  Send CV and Cover Letter to HR@aimmaxrx.com