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Director, Clinical Trial Management/Clinical Operations
4 months ago
Director, Clinical Trials Management/Clinical Operations
FLSA: Exempt
Reports to: President, R&D
Location: Hybrid
Date Prepared: 21,05,2024
The successful candidate will have demonstrated successful experience managing clinical operations in small or mid-sized CROs and/ or biopharmaceutical companies. Experience in the areas of radiopharmaceutical imaging, immunology, esophageal or gastrointestinal disease is highly desirable. This is a hands-on, dynamic position with the ability to grow and scale as NexEos advances its pipeline. This position requires in-office presence (Malvern, PA) up to 4 times per month and travel approximately 10 percent. The salary range for this position is $145-170K depending on qualifications.
Coordinate the planning, design, and execution of clinical trials for the NexEos Bio pipeline, ensuring adherence to all applicable regulations, standards, and guidelines.
Oversee the development and implementation of clinical trial protocols, informed consent forms, case report forms, investigator brochures, Annual Reports, and other essential documents.
Collaborate with cross-functional teams including vendors and partners to ensure effective trial initiation, monitoring, and completion, including site selection, Investigator training, monitoring of progress, and periodic communication.
Manage clinical data through effective relationships with SMEs, including medical, radiopharmacy, laboratory, biostatistics, and data management personnel. Prepare summaries and presentations to ensure clear presentation to stakeholders.
Data Analysis and Reporting:
Review and interpret clinical trial site performance, ensuring accuracy, consistency, and quality.
Collaborate with data management to ensure clinical databases are collecting data correctly and accurately for use in clinical data analysis.
Collaborate with biostatisticians to analyze study results, identify trends, and provide insights for future development strategies.
Manage the preparation of clinical study reports, investigator brochures, and other relevant clinical documents.
Leadership and Team Management:
Lead and manage Clinical Operations through the management of an outsourced CRO and clinical professionals, including Clinical Project Managers, Clinical Research Associates, Biostatisticians, and Clinical Trial Assistants.
Foster the engagement of consultants and vendor partners to maintain a collaborative and high-performing team culture.
Where applicable, set goals, develop dashboards, conduct evaluations, and provide feedback to vendors and team members.
COMPETENCY REQUIREMENTS
Strong collaboration skills, positive approach, constructive team dynamics, enthusiastic leadership
Bachelor’s Degree required, advanced degree preferred.
At least 6 years in Life Sciences industry (Pharma, Biotech, Medical Device) representing pre-clinical and clinical phases of development.
At least 3 years of leadership experience in Research, Clinical, or other relevant function with cross-functional team project management.
Hands-on experience in developing, implementing, and sustaining successful programs.
Working knowledge of US Regulations and Standards for Human Subjects.
Computer Skill
Proficiency in the use of PC and programs, particularly Outlook, Teams, Word, PowerPoint, SharePoint, Excel, project management tools and collaboration tools (or equivalents if changed by the Company), and SAP or equivalent business management software if applicable.
Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret complex concepts, identify risks, and work with team to collaboratively establish business direction.
Analytical Skill
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skill
Excellent industry vocabulary required. Ability to absorb and verbally communicate ideas and issues effectively to other team members and management. Ability to record, analyze, report and trend data and information as required.
Work Environment
The work environment characteristics described here are representative of those encountered while performing the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The areas in which this role is typically performed include a home office, general office or open cubicle/workstation environment with occasional travel to clinical sites, laboratories, and manufacturing environments. The noise level in the work environment is usually moderate.
ACCOMMODATION STATEMENT
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The information contained in this Role Description is intended as a general summary of responsibilities and requirements. Other duties, responsibilities, and tasks may be assigned as required.
