Associate Director, Clinical Trial Transparency at Cytokinetics

Radnor, Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, CardiovascularIndustries

Requirements

BA or BS in a life sciences-related discipline with a minimum of 9 years of combined experience relevant to CTT
Ability to work both independently and in cross-functional team environments with minimal supervision
Strong written and verbal communication skills, with ability to engage and disseminate information among appropriate stakeholders for effective development of CTT-related materials
Demonstrated ability to lead development of CTT-related deliverables, including excellent project-related written and verbal skills, timeline management, and issue identification/escalation
Ability to manage consultants/contractors
Demonstrated success in working cross-functionally and within a department on process initiatives including process development, SOP development, and initiatives related to new and emerging regulations/guidelines
Deep knowledge of CTT-related regulations and guidelines related to Clinicaltrials.gov, EU CTR, EMA Policy 0070, etc
Ability to interpret and assess impacts of new and emerging regulations and guidelines

Responsibilities

Participate in and/or lead development of clinical trial registry postings to registries/databases including Clinicaltrials.gov, EU CTIS, and other local/regional clinical trial registries
Oversee activities related to preparation of redacted information to be submitted to health authorities and published to clinical trial registries, including but not limited to EMA Policy 0070 packages, EU CTIS redacted document postings, and other CTT-related redacted document packages needed
Manage development of clinical trial plain language summary documents, in conjunction with Medical Writing and SMEs, as needed
Manage vendors and/or consultants supporting development of CTT-related documents/postings
Develop and manage consistent, clear timelines for authoring, review, and approval of CTT-related items, and ensure stakeholders are adequately informed of responsibilities and status of each deliverable in a timely manner
Proactively escalate potential timeline and/or content issues to management and/or appropriate functions within Cytokinetics
Lead and participate in CTT-related process development initiatives at Cytokinetics including but not limited to SOP development, project tracker development/maintenance, best practice development
Participate in Regulatory Affairs-specific and cross-functional initiatives related to CTT (e.g., EU CTR/CTIS process development)
Proactively monitor new and emerging CTT regulations and guidelines, providing clear and concise updates to impacted Cytokinetics functions including Regulatory Affairs, and Research and Development functions

Skills

ClinicalTrials.gov

EU CTIS

Clinical Trial Registries

Plain Language Summaries

Redaction Packages

EMA Policy 0070

Medical Writing

Regulatory Strategy

Vendor Management

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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