Director Clinical Science
$175,000–$225,000 year
RemoteUnited States
Job Summary
Lead clinical science planning and execution by developing Clinical Development Plans (CDPs), Lifecycle Plans, and integrated commercialization strategies. Design clinical protocols, manuals, and forms with oversight from Medical Directors, while collaborating with cross-functional teams including operations, regulatory, and business development to ensure consistent language across Informed Consent Forms and Case Report Forms. Conduct literature searches, analyze study data, and support site training and KOL interactions to drive study success. Prepare clinical science documentation for regulatory filings, HA meeting packages, and scientific presentations, coordinating submissions to meetings and managing protocol amendments. Maintain a current view of therapeutic trends and contribute to special projects as assigned.
Required Qualifications
- 7+ years' clinical trial experience with relevant therapeutic area experience
- 2+ years' experience in clinical science
- Data listing review experience is mandatory
- Experience authoring experimental protocols and/or study results and conclusions
- In-depth understanding of Phase 1 through 4 drug development
- Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
- Good business acumen; has working knowledge of the multidisciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
- Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment
- Good interpersonal, verbal communication and influencing skills; can influence without authority
- Strong written communication skills
- Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
- Ability to travel (~25%)
Desired Qualifications
- Advanced Clinical/Science Degree is preferred (e.g., PhD, PharmD, MD)
- Clinical and basic science research in tumor immunology preferred
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