Cytokinetics

👥 251-500💰 $550,000,000 Post-IPO Equity 9 months agoBiotechnologyBiopharmaHealth Care📈 Public Company
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Cytokinetics is a late-stage biopharmaceutical company pioneering the development of first-in-class muscle activators and next-in-class muscle inhibitors. We focus on treating debilitating diseases where muscle performance is compromised, primarily within the cardiovascular therapeutic area. Our innovative approach to muscle biology and the mechanics of muscle performance is driving the development of small molecule drug candidates to improve myocardial muscle function and contractility. Aficamten, our leading drug candidate, is currently making a significant impact in the treatment of hypertrophic cardiomyopathy. Our team utilizes a robust technology stack that includes WordPress, Amazon web services for hosting, and various tools like Google Tag Manager for analytics and Font Awesome for design. We value collaboration and a data-driven approach, ensuring our engineering practices are efficient and effective. Our mission is to improve patients' lives, which is reflected in our commitment to rigorous scientific thinking, integrity, and ethical practices. We're a values-driven company that encourages teamwork, innovation and puts patients at the heart of everything we do. Cytokinetics is a publicly traded company (NASDAQ: CYTK) with 251-500 employees. We boast a strong funding history and are actively expanding our global reach, with opportunities for both in-office and remote work across multiple departments and functions. We encourage individuals passionate about making a difference in the lives of patients with cardiovascular diseases to explore our career opportunities. We champion diversity and inclusion and are an equal opportunity employer.

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📍 United States

🧭 Contract

🔍 Biopharmaceutical

  • Advanced degree (MD, PhD, PharmD; MS with additional direct experience) in a life sciences or health-related field strongly preferred.
  • 3+ years of experience in clinical research, preferably within the biopharmaceutical or biotechnology industry.
  • Strong understanding of biostatistics and experience in interpreting clinical data.
  • Proficiency in medical writing and developing high-quality scientific documents.
  • Familiarity with Good Publication Practices (GPP) and experience in ensuring compliance with GPP guidelines in scientific writing and publication.
  • Experience with data visualization tools (e.g., GraphPad Prism, Tableau, R) and presentation software (e.g., PowerPoint).
  • Proven ability to create and generate scientific presentations for consumption by a diverse audience.
  • Familiarity with clinical trial design, execution, and regulatory requirements (e.g., FDA, EMA).
  • Excellent organizational, interpersonal, and communication skills.
  • Ability to work collaboratively in a multidisciplinary team environment.
  • Strong attention to detail and ability to manage multiple tasks simultaneously.
  • Collaborate with medical leads in the planning of early and late-phase clinical research studies.
  • Work closely with clinical pharmacology and drug safety teams to integrate pharmacokinetic and safety data into overall clinical study designs.
  • Provide outputs that may be incorporated into documents such as investigator brochures, clinical study reports, and other regulatory documents.
  • Conduct data reviews of clinical data sets and participate in statistical analyses in collaboration with biostatisticians.
  • Develop data visualization strategies to effectively communicate clinical trial data and outcomes.
  • Prepare scientific presentations for internal and external audiences, including scientific conferences, advisory boards, and regulatory meetings.
  • Contribute to the preparation and submission of manuscripts for publication in peer-reviewed journals, ensuring adherence to Good Publication Practices (GPP).
  • Support the development of clinical study documents, including study protocols, and patient-facing materials.
  • Maintain up-to-date knowledge of relevant scientific literature, therapeutic area trends, and regulatory requirements impacting clinical trials and drug development.

Data AnalysisPresentation skillsData visualization

Posted 17 days ago
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📍 United States

🧭 Contract

💸 80.0 - 100.0 USD per hour

🔍 Biopharmaceutical

  • University Degree or equivalent, preferably in a medical/science-related field.
  • 8+ years of related experience.
  • Demonstrated knowledge of clinical trials and project management.
  • Knowledge of ICH guidelines.
  • Update knowledge on regulatory requirements and ensure compliance.
  • Execute all start-up activities prior to site activation on assigned studies.
  • Prepare Informed Consent Forms and obtain necessary approvals.
  • Analyze study start-up data for efficiency and opportunities for improvement.
  • Partner with Clinical Trial Managers on regulatory requirements and site activations.
  • Support drug label preparation for studies as required.
  • Collaborate with authorities to enhance clinical trial processes.
  • Collaborate with CTMs on new investigator sites and patient recruitment.
  • Responsible for study budget and contracts negotiation.

Project ManagementData AnalysisComplianceBudgetingStakeholder management

Posted about 1 month ago
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📍 United States

🧭 Full-Time

💸 147000.0 - 163000.0 USD per year

🔍 Biopharmaceutical

  • Bachelor's degree in life sciences, information technology, or business.
  • 6+ years of experience in pharmaceutical Regulatory Operations or similar discipline.
  • Hands-on experience publishing original applications and maintenance submissions for various regulatory applications.
  • Proficient knowledge of electronic publishing tools for regulatory submissions.
  • Expert knowledge of eCTD submission requirements and lifecycle management concepts.
  • Strong project management, communication, and interpersonal skills.
  • Ability to work independently and troubleshoot system errors.
  • Publish high-quality electronic regulatory submissions for global health authorities.
  • Manage and triage workload for large/complex submissions.
  • Perform quality control checks on formatted documents prior to submission.
  • Provide training on document templates and style guides.
  • Identify and resolve document formatting and publishing issues.
  • Monitor changes to submission guidance and update processes.
  • Assist with development of new department SOPs.

Project Management

Posted 4 months ago
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