Location: Greater Philadelphia Region
Contact: Jackie Bandish, email@example.com
Clinical Development Associate Director | Medical Device Company
This Associate Director search is being conducted on behalf of our Medical Device client who has FDA approval for the treatment of depression. This treatment has the CE mark of approval and is used globally.
This individual will be responsible for the management and oversight of clinical studies or clinical projects. One will conduct clinical studies including protocol, site selection, data collection to finalization of clinical study reports, and development of study related documents.
Additionally, one will lead study team and provide input cross functionally to ensure study plan aligns with business development strategies.
Location: This company is located in the metro Philadelphia area in an area that allows for easy commute to local major roadways.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
Publicly held medical device company with 120 employees.
The environment is high-energy.
This person must have the ability to effectively manage multiple priorities and have excellent problem-solving ability.
HIGHLIGHTS OF RESPONSIBILITIES:
Ensure conduct of clinical studies comply with the study protocol, applicable Standard Operating Procedures (SOPs), and ICH (International Council for Harmonization) requirements for GCP and other relevant regulations.
Plan study budgets, develop timelines and manage clinical studies/projects to the approved budget and timelines.
Oversee, lead, and/or prepare clinical study documents [e.g., protocol, informed consent form (ICF), case report forms (CRFs), clinical sections of the Instruction For Use (IFU) and clinical study report (CSR)].
Identification and selection of clinical study sites and management of investigator and key opinion leader (KOL) relationship.
Provide input to evaluate and select vendors/contractors [e.g., Clinical Research organizations (CROs), central laboratories, contract monitors] in accordance to study requirements and company SOPs.
Define the scope of work to be outsourced, supervise outsourced tasks, and manage vendor/contractor relationships.
DESIRED SKILLS AND QUALIFICATIONS:
BA/BS degree in life sciences or related discipline.
8+ years of relevant experience in clinical development organization managing clinical trials in the biotech/pharmaceutical industry.
Good understanding of the device/drug development process.
Jackie Bandish, Head of Life Sciences Recruiting and Operations
Phone: 267-483-5233 x 104
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Warrington, PA 18976