Overview

The Director of Clinical Operations is a critical leadership position and is responsible for leading all clinical operations activities within the organization. This individual will be primarily focused on managing and executing domestic and international clinical studies, ensuring rapid enrollment, overseeing exceptional site management, and selecting and managing CRO?s with strong skills in the high-quality data collection, statistics and analysis. This position is responsible for multi-therapeutic, multi-national project and program management, and clinical operations in Phase 1 to 3 drug development programs.

Detailed Description

The Director of Clinical Operations is a critical leadership position and is responsible for leading all clinical operations activities within the organization. This individual will be primarily focused on managing and executing domestic and international clinical studies, ensuring rapid enrollment, overseeing exceptional site management, and selecting and managing CRO’s with strong skills in the high-quality data collection, statistics and analysis. This position is responsible for multi-therapeutic, multi-national project and program management, and clinical operations in Phase 1 to 3 drug development programs.

Key Responsibilities:

• Responsible for large study and/or multiple study management, including the overall clinical project plan, study timelines and deliverables, as well as risks and contingencies
• Responsible for leading clinical study team to ensure alignment to timelines, risk management and data quality.
• Oversee clinical operations budget and financial reporting, including CRO and site contractual agreements.
• Lead the selection of vendors (CRO, IRB, Central Lab, etc.) and study sites.
• Develop and oversee patient recruitment strategies, project metrics tracking, and Trial Master File (TMF) design and set up.
• Author and review study documents (Protocol, IC, monitoring plans, pharmacy manual, Informed Consent Form, DSMB/Steering Committee/Charters, CSR).
• Responsible for vendor, PI and committee management and communication.
• Ensure all aspects of GCP are complied with at all times
• Coach CRAs in various aspects of the trial that are relevant to particular project issues. Implement training programs for CRAs and clinical site staff.
• Establish and maintain effective communication and collaboration with functional area peers, as well as leaders in order to meet program objectives and support achievement of goals. Serve as liaison between clinical, pre-clinical, manufacturing, regulatory, and legal departments.

• Drive functional excellence by implementation of innovative and best-in-class procedures related to clinical trial execution, establishing global standards in SOPs/WI.
• Lead overall strategy and support inspection readiness activities and responses to audit findings.
• Work closely with all members of the executive leadership team to facilitate driving new product development, global product registration and commercial release of the new products.

Supervisory Responsibilities:

• Supervise and mentor a team of direct and indirect reports to assure performance/progress on assigned projects as appropriate.
• Responsible for managing program resource needs (time, financial, manpower).
• Ensure direct reports are compliant with required training.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing or Pharmacy. Medical background and advanced degree preferred.
• Minimum of 10 years’ experience in the pharmaceutical industry or clinical research organization.
• Extensive experience developing project and budget plans as well as global clinical management and budget oversight experience.
• Experience running clinical studies in both the US and international and experience with regulatory filings from IND to NDA in US and abroad.
• Strong project management skills, including budget analysis.
• Advanced knowledge of statistics and clinical study design.
• Knowledge of clinical studies in infectious disease, specifically antimicrobial research.

• Strong leadership skills and experience leading teams.
• Advanced knowledge of pharmaceutical business, drug development, regulatory and compliance requirements with extensive knowledge of clinical operations, project management principles and tools.
• Detailed knowledge of Good Clinical Practices (GCP).
• Demonstrated expertise in oversight of CRO relationships and performance as well as risk management and implementing mitigation plans at study and program level.

• Strong interpersonal and communication, problem solving and organizational skills and ability to manage multiple projects.

• Proficient MS Office skills including Microsoft Project
• Therapeutic experience in design and conduct of Phase I (pharmacology studies, bioequivalence, pharmacokinetic and pharmacodynamics), and phase II/III trials in infectious disease preferred

• Ability to travel (approximately 10%).

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

The base salary range for this full-time position is $190,000 - $230,000 annually. This salary range is an estimate and may vary based on the Company’s compensation practices.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

EEO

Qpex Biopharma Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable law.

It is the policy of Qpex Biopharma Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.