Associate Director of Clinical Operations
The Associate Director, Clinical Operations manages the clinical development program(s) including study protocol enrollment risks and execution, outsourcing strategy, vendor identification and vendor qualification, geographical execution strategy, site contract and budget drivers, trial initiation, study conduct, proactive initiatives for study recruitment and retention, and close-out activities. This position oversees adherence to defined study and CRO performance metrics, SOPs, Good Clinical Practice and FDA regulations. The Associate Director, Clinical Operations shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.
Principal Responsibilities and Accountabilities:
- Perform duties on site, on time, and within the Company's normal business hours listed in the Employee Handbook. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues. Presents a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
- Serve as a liaison with vendors and Company personnel to proactively identify execution issues, study protocol adherence and compliance issues. Manages the execution, at times, across different functions, to support all aspects of clinical project execution including timelines, budgets, metrics and reports. Responsible for defining and managing the risk mitigation study activities, including those of clinical monitoring process, clinical trial administration, data management, and reporting. Responsible for identifying issue of vendor performance.
- Participate in development of the clinical trial strategy for the clinical development program. Identify program and protocol risks and develop strategies to de-risk. Coordinate and assist in the draft of language for study protocols and study reports in collaboration with the medical monitor; review study documents including ICF, CRF, SAP, DMP, TLF and CSR.
- Drives regular interaction with the study team members, and vendors to identify scope impact for new projects, and updates to existing scope. Communicate professionally and effectively with relevant stakeholders regarding study design and execution including vendors and investigators.
- Work collaboratively with Clinical Outsourcing to align vendor proposals with outsourcing strategy. Assists in finalization and maintenance of vendor contracts for clinical studies. Establish initial study budgets and reports variances to Operations and Finance.
- Follow established clinical study standards and procedures (ICH and GCP) according to quality systems and regulatory requirements. May develop and implement clinical and study specific SOPs and study document templates to support Clinical Operations.
- Support the instruction of Vendor and/or study team members to support development of case report forms, data entry guidelines, completion guidelines and other procedures and tools for study execution and data collection as needed.
- Develop and maintain enrollment projection timelines, compile and maintain regular status reports of study progress and study specific timelines.
- Perform other duties as may be assigned from time to time.
- BS or MS in public health, science or a related discipline required.
- Typically BS with 10 to 15 years, MS with 8 to 12 years, or PhD with 5 to 10 years of clinical development and/or program management experience in biotechnology or pharmaceutical industries.
- Expert knowledge of GCP, ICH and all phases of clinical trial execution.
- Supervisory experience leading and directing the work of others expected.
- Practical experience with EDC systems, statistical analysis plans, and trial master files.
- Self-motivated team player with a strong work ethic, exceptional interpersonal skills, and ability to make decisions independently. Excellent written and verbal communication with the ability to present results in a clear, precise, and timely manner.
- Ability to multi-task and function effectively in an interrupt-driven and fast-paced work environment.
- Strong computer skills with proficiency using MS Office software Excel, Word, PowerPoint, and MS Project required.
- Independent decision-making that will impact multiple studies.
- Ability to manage clinical programs on time and within budget including managing CROs and other vendors.
- The qualified applicant shall demonstrate: a) sound reasoning; b) progressive learning agility; c) versatility or being capable of doing many things competently; and, d) resilience from a disappointment or setback.
- Values achieving milestones, including team and company goals.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours. Some travel may be required (up to 25%).
Novan maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
Novan, Inc. is an equal opportunity employer and actively seeks candidates from diverse backgrounds including women, communities of color, the LGBT community, and people with disabilities.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.