Associate Director, Clinical Science

Welcome to the Tarsanet Internal Career Center!; Irvine (CA); Hybrid; USD 165,000 - 231,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Generous paid time off

Stock equity

Job summary

Welcome to the Tarsanet Internal Career Center! Join our team in Irvine, California, to enhance clinical strategies for therapies focusing on unmet needs. We seek a leader proficient in clinical trial protocol authoring, with over 10 years of experience in pharma or biotech. The position offers a hybrid work environment and compensates between $165,000 to $231,000, including bonuses and stock equity. This role may require some travel of up to 50%.

Qualifications

• 10+ years minimum experience with 3+ years of pharma/biotech experience.
• In-depth understanding of drug development is essential.
• Experience with Good Clinical Practice and regulatory guidelines.

Responsibilities

• Lead cross-functional team collaborations to synthesize clinical data.
• Primary author of clinical trial protocols and related documents.
• Educate team members on protocol execution and medical data review.

Skills

Clinical trial protocol authoring

Collaboration skills

Data analysis techniques

Strong presentation skills

Teamwork and negotiation

Education

Advanced clinical/science degree (PharmD, PhD, OD, MD)

Job description

About the Role

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.

Responsibilities

• A leader with influence to 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.

Factors for Success

• Advanced clinical/science degree preferred (PharmD, PhD, OD, MD).
• 10+ years minimum experience, with 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist) and 5+ years of experience with clinical trials. Eye care experience preferred.
• Experience authoring clinical trial protocols and/or study results and conclusions, applying creative thinking and adaptability for early development programs.
• 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 Harmonisation, 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.
• Decision Making – Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome‑oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
• Collaboration and Team Building – Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
• Outcome Driven – Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

Recruitment & Compensation

Base pay range $165,000 – $231,000 plus bonus, stock equity, and comprehensive benefits. Benefits include health, dental and vision insurance, generous paid time off, including vacation, holidays, and personal days. The position is based in Irvine, California with a hybrid work environment and remote options; some travel may be required – up to 50%.

Equal Employment Opportunity

We do not discriminate on the basis of any protected group status under any applicable law. We are committed to equal opportunity in employment for all qualified candidates.