Associate Director, Toxicology at Cytokinetics

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, CardiovascularIndustries

Requirements

(None specified in the provided text)

Responsibilities

Design, manage, analyze, interpret, and report on safety pharmacology and toxicology studies, including general toxicology, genetic toxicology, developmental & reproductive toxicology (DART), and toxicokinetics
Draft, review, and approve toxicology study protocols, reports, associated nonclinical summaries, regulatory submission sections, and documentation
Prepare abstracts/manuscripts for publication
Provide strategic toxicological assessments and preclinical guidance to project teams and senior management
Oversee contracts, budgets, and CRO relationships for outsourced toxicology/safety pharmacology studies
Maintain up-to-date toxicology plans for all IND and NDA enabling projects/programs, including study listings, timelines, status, and costs
Assess the risk of drug candidates on reproductive health

Skills

Toxicology

Safety Pharmacology

Genetic Toxicology

DART

Toxicokinetics

CRO Management

Study Protocols

Regulatory Submissions

IND

NDA

Risk Assessment

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

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