Associate Director, Clinical Science Liaison

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Overview

The Associate Director, Clinical Science Liaison provides clinical development expertise into a multi-disciplinary team engaged in advising clients, internal stakeholders and interacting with sites and investigators in early through late-stage development of medical products. This role will provide clinical science liaison support as a member of core study teams responsible for establishing relationships with KOLs/PIs to provide enhanced peer-to-peer clinical/medial support enabling prioritization of trial recruitment and quality trial delivery and addressing scientific trial queries. The role will also support the PPD clinical trial proposal process to provide trial design considerations, and operational enhancement of trial execution.

Duties and Responsibilities

Strong teamwork skills required to work with a cross-functional consulting team (e.g., experts in clinical development strategy, clinical research, regulatory strategy, CMC and toxicology strategy, biostatistics, clinical pharmacology and pharmacokinetics). In addition, this role will be involved in projects in partnership with clinical trials teams, who will provide additional training and guidance. Responsibilities, including:

• Clinical science liaison activities including supporting KOLs, PIs and clinical trial sites by actively engaging with site personnel, overcoming recruitment challenges and concerns.
• Contribute to clinical trial scientific deliverables by providing scientific review and input to key study documents ensuring scientific rigor, consistency, and alignment with strategy.
• KOL mapping and coordination of key opinion leader advisory boards
• Contribute to clinical trial feasibility outreach through P2P discussions
• Support Clinical Development Leads with competitive intelligence for clinical development plans and strategic program assessments, regulatory submissions, and trial design.

Education and Experience

• MD, PhD, PharmD, or equivalent in a scientific discipline or related field required
• Expertise and experience with the conduct of global clinical trials for medical products clinical training and/or experience strongly preferred
• Seeking an experienced professional with exceptional client and site personnel facing skills.

• Familiarity with various clinical trial designs, including more complex trials, study outcome interpretation skills
• 6 + years of experience (following receipt of doctoral degree) in a clinical research setting, such as biotech/pharmaceutical industry, academia, government and/or non-profit.

• Experience in Respiratory Medicine, Neuroscience/Ophthalmology or Immunology/Rheumatology/Inflammation with the ability to cross-cover in additional therapeutic areas is strongly preferred
• Expert in navigating scientific literature, interpretation of data and display of data

• Knowledge of GCP/IHC, regulatory guidelines and precedents
• Excellent interpersonal and communication skills. Strong attention to detail. Good organizational, prioritization and time management skills.
• Ability to work on multiple projects simultaneously
• Ability to work both independently and in a team environment
• Highly proficient in standard computer software (MS Word, Excel, PowerPoint), Clinical Trial Databases, Clinical Trial Intelligence Tools.
• Ability to speak multiple languages preferred

Originally posted on Himalayas