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.
Job Purpose
The Senior Manager, Clinical Operations is responsible for the clinical project management and oversight of assigned clinical study(ies). The Senior Manager is the Study Operations Team Leader and partners with the cross-functional Study Team members to ensure adherence to the company’s SOPs and ICH/GCP, that study specific procedures are followed, and that the project scope, schedule, resources and budget are managed appropriately. Participates in strategic activities relating to department infrastructure and is responsible for hiring, performance, development and coaching of direct reports, if applicable.
Responsibilities
- Oversee and manage all aspects of a clinical trial in accordance with the company’s SOPs, ICH/GCP regulations and study-specific manuals and procedures
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and follow-up with the Study Team to determine appropriate action
- Management of CROs and other vendors; ensuring that decision-making is in alignment with the company’s expectations and identify areas of concern and escalate to CRO or manager as appropriate
- Ensure proper CRO resourcing and clarify of team roles across CROs, vendors and Cytokinetics. Communicate project related concerns and goals to CRO and other vendors, and, as needed, escalate to manager
- Manage the clinical study budget including spend trending; ensure the project remains within scope and that any out of scope activities are identified and handled appropriately
- Establish and maintain tracking metrics to monitor trial and team progress towards project goals
- Prepare project status updates for the Study Team and management
- Ensure appropriate communication of issues and decisions are communicated to CROs, other study vendors, and manager
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study manuals, case report forms, and any other clinical research related documents.
- Provide review and comments on all study materials and assess when items/issues must be escalated to manager (i.e., those impacting all functional areas, timeline, cost)
- Lead the CRO and vendor identification and selection process in accordance with the SOP
- Review, negotiate and approve Clinical Operations’ vendors’ scopes of work (SOWs) and budgets and, if needed, provide recommendations to and consult with manager
- Develop and maintain good working relationships with investigators and study staff, serving as an ambassador to promote Cytokinetics’ high quality and ethical standards
- Establish trusting, respectful relationships with internal and external colleagues; influence stakeholders in a collaborative manner
- Supervise the activities of one or more direct reports (e.g., clinical trial managers) to achieve study, clinical program, and company objectives.
Qualifications
- BA/BS in science or health related field with 8+ years in the pharmaceutical/biotech industry and relevant work experience including at least 5 years overseeing trial management
- At least 2 years of direct management of clinical staff
- Demonstrated ability to develop and implement study plans and processes
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Excellent written and verbal communication skills required
- Exceptional interpersonal skills with demonstrated successful team participation
- Demonstrated skill in managing multiple tasks simultaneously, with attention to detail without being stuck in the details
- Ability to work under pressure and deal with time demands
- Ability to work effectively in a cross-functional team environment
- Ability to proactively identify issues and address with a solutions-oriented approach
- Ability to think strategically and make independent decisions
- Proactively and independently identify issues/risks and solutions/mitigations and effectively communicate the information to the relevant party (cross-functional teammate, manager, vendor, etc.) to obtain support/approval
- Some travel (domestic and international) will be required (approximately 10-15%)
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.Salary Pay Range$171,000—$209,000 USDOur 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
