Job Details

Director of Clinical Operations—North Carolina

Tanner and Associates is recruiting a Director of Clinical Operations. This job is based out of North Carolina.

The Director of Clinical Operations will plan, execute, and supervise all operational activities pertaining to clinical studies, oversee the performance of clinical operations staff, and lead departmental activities.

Key Accountabilities/Responsibilities:

1. Ensures that proper activities are undertaken for timely and quality set-up, planning, and management of clinical trials to meet corporate objectives.
2. Manages interdepartmental activities specific to implementation and conduct of protocols – may lead study teams.
3. Reviews and approves clinical outsourcing specifications for RFPs and may manage CROs for their performance.
4. Ensures the collection of high-quality clinical data; participates in the analysis of clinical data.
5. Ensures departmental processes are efficient and comply with applicable regulatory and company requirements.
6. Ensures proper and timely resolution of CQA audit findings.
7. Leads and/or coordinates initiatives to improve processes within Clinical Operations.
8. Ensures a high level of customer service for clinical study sites and internal clinical study teams.
9. Develops and maintains long-term relationships with key investigators, opinion leaders, and other industry leaders.
10. Stays abreast of the latest developments in clinical trial management, drug development, and, where possible, contributes to advances in the field.
11. Promotes and communicates the role of the Clinical Operations department (internal/external).
12. Provides input and due diligence to in-licensing proposals.

Requirements:

1. MS, MSN, MBA, PharmD, MPH in biological sciences or related field, or BS degree will be considered with substantial clinical trial and personnel management experience.
2. 14+ years of progressive experience in life sciences, with 10+ years of biopharmaceutical industry experience.
3. 5+ years of management experience.
4. Experience in Immunology and/or Cardiovascular therapeutic area preferred.
5. Expert knowledge of regulatory and clinical practices (GCP, etc.).
6. Demonstrated matrix leadership skills, including leading interdisciplinary trial execution teams.
7. Detailed knowledge of the concepts of clinical research and drug development.
8. Proven ability to provide scientific and clinical expertise to a clinical development program.
9. Proficiency in clinical studies involving complex design issues.
10. Experience with regulatory filing.
11. Experience with management of multinational clinical trials.
12. Ability to travel 25%-50% – both domestic and internationally.
13. Strong time management and organizational skills, proven ability to prioritize workload, manage to deadlines, and be accountable.
14. Attention to detail and accuracy in work.
15. Demonstrated aptitude and knowledge in relevant therapeutic area and/or ability to learn and integrate new/different therapeutic areas.
16. Strong verbal, presentation, and technical writing skills.
17. Solid working knowledge of word processing, spreadsheet, email, and presentation software (MS Office suite).
18. Hands-on, team player mentality.
19. Experience and comfort in working both independently and as part of a multifunctional team.
20. Commitment and ability to handle high workloads, demanding situations, and deadlines.