Associate Director, Clinical Science

the Tarsanet Internal Career Center•Irvine, CA

7d•Hybrid

About The Position

Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs. This role will be focused on the development of clinical strategies for assigned programs and is responsible for ensuring effective and efficient execution of the clinical development plan.

Requirements

10+ years minimum experience
3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist)
5+ years of experience with clinical trials
In-depth understanding of drug development.
Working knowledge of basic biostatistics
Experience working with techniques of data analysis, interpretation, and assessment of clinical relevance.
Well-versed in medical aspects of Good Clinical Practice, International Council for Harmonization, Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence and other relevant guidelines and regulations.
Has demonstrated, through past experience, abilities to competently manage the majority of clinical science deliverables associated with assigned clinical studies.
Strong presentation skills: effective at summarizing and presenting the key considerations and decision points.
Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc.
Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end results.
Able to work in a fast-paced dynamic organization.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.

Nice To Haves

Advanced clinical/science degree preferred (PharmD, PhD, OD, MD).
Eye care experience preferred.
Experience authoring clinical trial protocols and/or study results and conclusions, applying creative thinking and adaptability for early development programs.

Responsibilities

Present and collaborate with cross-functional team members to synthesize clinical data.
Primary author for assigned clinical trial protocols, collaborating with and leading with other functions required for protocol development.
Contributes or reviews clinical, regulatory, and relevant study documents, including Investigator Brochures, Clinical Study Reports, Statistical Analysis Plans, Operation Manuals, Investigational New Drug Applications/Clinical Trial Applications, case report forms, and data tables listings and figures.
Educates internal and external team members on protocol execution.
Primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors, regarding study protocol, informed consent, and patient-specific questions.
Reviews, finalizes, and updates information/data entered in clinical trial registries.
Participates in development of Clinical Development Plan.
Partners with data management on resolution of all clinical queries to sites.
May participate in health authority interactions, as well as interactions with site Institutional Review Boards/ethics committees.
Contributes to scientific abstracts for submissions to scientific conferences and publications for peer-reviewed journals.
Creates, reviews, and/or presents clinical slides for internal meetings and external forums.
Collaborates with biostatistics to develop data tables, listings, and figures.
Identifies and tracks any potential safety events within a given study, or across studies for assigned programs.
Conducts medical data review.
Provides clinical development input to proposed revisions of SOPs and guidance documents.