AD of Clinical Development

Malvern, Pennsylvania
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 142011

Date Posted: 06/13/2019

Job Title: Associate Director, Clinical Development

Location: Malvern PA

Employment: Direct Hire, competitive compensation plus bonus



Position Overview: 
Management and oversight of clinical studies or clinical projects. Responsible for conduct of clinical studies including protocol, site selection, data collection to finalization of clinical study reports, and development of study related documents. Ensure compliance with good clinical practice (GCP) and relevant regulatory requirements/guidelines. Lead study team and provide input cross functionally to ensure study plan aligns with business development strategies.

Essential Duties/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
• Plan, present and participate at Investigators Meetings
• Assist with the reporting and data analysis of clinical results
• Ensure clinical studies/projects are inspection ready as appropriate 
• Other Duties as needed/required and delegated by the supervisor

Knowledge, Skill, and Abilities: 
• Ability to effectively manage multiple priorities
• Excellent problem-solving ability
• Excellent organizational skills, attention to details, commitment to quality, and ability to work independently
• Excellent oral and written communication skills
• Excellent interpersonal skills
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Project)

Education and Experience: 
• 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
• Working knowledge of GCP/ICH guidelines and FDA/EMA regulations

Preferred Skills:
• Psychiatry/neuroscience experience preferred
• Device experience preferred
• Experienced in the management of direct reports




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