Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
The Contract Senior Study Start-up Specialist (Sr SSUS) is responsible for all SSU-related activities on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.Primary Responsibilities:
- Update knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures
- Execute all start-up activities prior to site activation on assigned studies, according to CYTK standards and aligned with study/project requirements and timelines
- Prepare Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country
- Analyze and maintain study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
- Partner with Clinical Trial Managers to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations
- Support drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
- Liaise and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies! laws, via innovative approaches
- Colloborate with CTMs to identify and track new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required
- Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country
Qualifications:
- University Degree or equivalent, preferably in a medical/science-related field with 8+ years of related experience
- Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
- Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered.
If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
