Associate Director, Clinical Development Science

Work Schedule

Environmental Conditions

Job Description

Position Overview

The Associate Director, Clinical Development Science is responsible for providing clinical development expertise into a multi-disciplinary team engaged in consulting with clients for early through late-stage development of medical products. The Associate Director, Clinical Development Science will provide expertise to the design and conduct of clinical trials, e.g., through contributing to protocol development and implementation, development of statistical analysis plans and interpretation of data and generation of clinical study reports. The Associate Director, Clinical Development Science will act as a clinical science liaison 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 Associate Director, Clinical Development Science will also support the PPD clinical trial proposal process to provide research and analysis to summarize the epidemiology, standard-of-care and competitive environment for the given opportunity.

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:

• Developing, designing, and optimizing clinical trial protocol synopses and full Phase I-IV clinical trial protocols
• Clinical science liaison activities including supporting KOLs, PIs and clinical trial sites.
• Contributing to clinical trial scientific deliverables by providing scientific review and input to key study documents ensuring scientific rigor, consistency, and alignment with strategy.
• Creating clinical development plans and strategic program assessments
• Assisting in coordination of key opinion leader advisory boards
• Contributing to clinical trial feasibility assessments
• Contributing to clinical trial scientific deliverables
• Providing competitive intelligence support for the request for proposal process
• Providing clinical strategy into health authority briefing packages
• Support for Pre-IND, IND, NDA/BLA and other US regulatory submissions
• Support for global regulatory submissions

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 facing skills.

• Strong teamwork skills required to work within a cross-functional consulting team (e.g., in regulatory strategy, product development, biostatistics and pharmacokinetics).
• Familiarity with various clinical trial designs, including more complex trials (e.g., basket trials, umbrella trials, adaptive designs, master protocols, decentralized trials, pragmatic trials)
• 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.
• Deep experience in at least one therapeutic area strongly preferred
• Familiarity with the operational conduct of global clinical trials
• Knowledge of GCP/IHC, FDA and other regulatory guidelines
• Knowledge of global requirements for regulatory approval and marketing of medical products
• Excellent interpersonal and communication skills
• Strong attention to detail
• Good organizational, prioritization and time management skills
• Ability to work on multiple projects simultaneously
• General familiarity with biostatistics and pharmacokinetics
• Expert in navigating scientific literature, interpretation of data and display of data
• Ability to work both independently and in a team environment
• Highly proficient in standard computer software (MS Word, Excel, PowerPoint