Associate Director, Clinical Development

Irvine, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates should possess an advanced clinical/science degree (PharmD, PhD, OD, MD) and a minimum of 10 years of experience, including at least 3 years in pharma/biotech or equivalent clinical research experience, with 5 years focused on clinical trials. Experience in eye care is preferred. A strong understanding of drug development, basic biostatistics, and data analysis techniques is essential, along with familiarity with Good Clinical Practice, ICH, FDA, EMA, NICE, and other relevant regulations. Demonstrated ability to manage clinical science deliverables for studies and strong presentation, teamwork, and negotiation skills are required.

Responsibilities

The Associate Director, Clinical Development will lead the development of clinical strategies for assigned programs and ensure the efficient execution of clinical development plans. This includes authoring clinical trial protocols, contributing to and reviewing various study documents such as Investigator Brochures, Clinical Study Reports, and regulatory applications. The role involves educating team members on protocol execution, serving as the primary contact for site inquiries, and managing clinical trial registry updates. Responsibilities also include partnering with data management to resolve clinical queries, participating in health authority and IRB/ethics committee interactions, contributing to scientific publications and presentations, and reviewing medical data. Additionally, the Associate Director will identify and track safety events, review clinical slides, and provide input on SOP revisions.

Skills

Clinical Development

Clinical Strategy

Protocol Development

Investigator Brochures

Clinical Study Reports

Statistical Analysis Plans

Investigational New Drug Applications

Clinical Trial Applications

Data Management

Cross-functional Collaboration

Health Authority Interactions

Tarsus Pharamceuticals

Develops treatments for eye care diseases

About Tarsus Pharamceuticals

Tarsus Pharmaceuticals develops treatments for diseases that lack effective solutions, focusing mainly on eye care and infectious diseases. Their key product, XDEMVY, is an FDA-approved eye drop solution used to treat Demodex Blepharitis, a condition affecting the eyelids. The company is also working on other potential treatments for conditions such as Lyme Disease Prevention, Meibomian Gland Disease, and Rosacea. Tarsus differentiates itself from competitors by concentrating on specific medical needs and maintaining a strong pipeline of future products. Their goal is to provide effective treatments for patients suffering from these conditions while ensuring compliance with regulations and ethical standards.

Irvine, CaliforniaHeadquarters

2017Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Paid Vacation

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in ophthalmic treatments challenges Tarsus's market position.

Potential clinical trial delays could affect Tarsus's product pipeline.

Supply chain constraints may hinder XDEMVY's production and distribution.

Differentiation

Tarsus focuses on high unmet needs in ophthalmic and infectious diseases.

Their lead product, XDEMVY, is FDA-approved for Demodex blepharitis treatment.

Tarsus's pipeline includes innovative treatments for Lyme disease and Rosacea.

Upsides

Growing awareness of Demodex blepharitis expands market for Tarsus's XDEMVY.

Telemedicine rise offers new marketing opportunities for Tarsus's products.

FDA's focus on unmet needs may expedite Tarsus's pipeline approvals.

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