Director of Clinical Operations in Durham, NC at Apex Life Sciences

Date Posted: 8/29/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/29/2018
  • Job ID:
    881931

Job Description


The Director Clinical Operations will be a manager with extensive experience in personnel management, operations, institutional and professional business planning, strategic planning, and management in a pharmaceutical or clinical research organization (CRO) setting who will work closely with senior leadership teams in setting and meeting company goals. This position will be responsible for ensuring efficient and productive clinical operations as well as assisting and collaborating in strategic drug development program implementation. The position will work to develop and implement key new values and added initiatives focused on the coordination of the company’s clinical programs; as well as the integration of the clinical strategic plan into the research, and product developmental missions

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Contribute to the preparation for approval of Clinical Development Plans, budgets and proposed go/no-go decision criteria for one or more global development programs ensuring the needs and requirements of all regions are met.
  • Manage internal resources, external partners, consultants, vendors and external budgets to ensure the timely and cost-effective implementation of the Clinical Development Plan for one or more global development programs.
  • Supervise and mentor direct and indirect reports, as necessary.
  • Assess and recommend CROs and preferred vendors for implementation of clinical studies.
  • Review and approve contracts, work orders and invoices within grant of authority.
  • Coordinate and manage production of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans and clinical study reports.
  • Represent Clinical Development in integrated product development clinical sub-teams to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide.
  • Establish and maintain effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders in order to meet program objectives and support achievement of department and corporate goals.

REQUIRED EDUCATION/EXPERIENCE/SKILLS

Experience

  • Requires a BS or BA in a relevant scientific discipline and a minimum 10 years of relevant pharmaceutical clinical development experience in a sponsor or CRO role and at least 5 years in a management role.
  • Demonstrated experience in the development, implementation, management and completion of more than one major, global, clinical program.
  • Experience in development of SOPs, CSRs, INDs, eCTDs, and other clinical, regulatory, and safety documents.
  • Experience in managing staff as well as mentoring and developing junior staff.
  • Experience in developing RFPs and selection and management of CROs/vendors.

 
Distinguishing Characteristics of this Level:

  • Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in clinical trial design, conduct and interpretation of scientific data.
  • Additional requirements include strong leadership and inter-personal skills and the ability to manage and cultivate relationships and foster employee development and the ability to recommend/make high-level decisions and to communicate effectively on a senior management level and externally.

To apply for this position please send CV to Vickie Dagit, Recruiter, vdagit@apexlifesciences.com  

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




881931