- Oversee functional deliverables to support program objectives as defined in the clinical development plan, identify risks, develop risk mitigation plans, and escalate risks and risk mitigation strategies to the Director, Clinical Operations as appropriate.
- Independently manage progress of trials to plan by managing study scope, timeline and resources within parameters defined in the development and operating plans.
- Responsible for assisting with drafting of clinical trial protocols and ICFs,
- Accountable for finalizing ICF templates, reviewing site-requested ICF changes, and being the Clinical Operations decision maker.
- Responsible for planning internal and external logistics and activities/services required for the conduct of clinical trials.
- Assess and select sites and approve sites for activation.
- Will be part of a team that reviews and finalizes CRO and vendor work orders (SOW, budget) and change orders,
- Approve CRO and vendor scope change forms.
- Monitor overall study budget and vendor spend and inform Director, Clinical Operations if study's overall budget variance +/- 2% is projected.
- Work closely with Clinical Operations senior management as well as the project medical monitor(s) during the conduct of clinical trials.
- Accountable for ensuring compliance with FDA regulations and ICH guidelines relating to industry sponsored clinical research to lead an internal group and/or engage vendors who ensure compliance with both the Code of Federal Regulations and ICH GCPs directly.
- Routinely provide updates regarding study status to senior management and responsible for ensuring that study management teams are led collaboratively and productively with representatives from clinical research, finance, regulatory affairs, project management, drug safety, biometrics, manufacturing and legal.
- Accurately project resource needs and inform Clinical Operations senior management to ensure timely hiring of resources.
- Partner with Clinical Operations team members to identify and develop efficient systems for enhancing department efficiency.
- Will be part of a team that evaluates, selects and manages contract research organizations, contractors, specialty laboratories and other vendors as well as internal support staff.
- Review of invoices from CROs, other vendors, and contractors
- BA/BS in science or health related field with 10+ years industry experience and relevant work experience in which at least 7 years has been in a clinical management role.
- Proven experience in managing the operations of domestic and international clinical trials.
- Demonstrated project management experience and leadership skills (e.g. leading cross functional study teams, managing vendors, managing outside collaborators).
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
- Ability to proactively identify issues and address with solutions-oriented approach.
- Ability to work under pressure and deal with time demands.
- Makes tough decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure.
- Comfortably delegates tasks and shares responsibility and accountability.
- Can effectively cope with change, can shift gears comfortably.
- Strong interpersonal and written communication skills; ability to flex communications (message, style) based on the audience.
- Strong team building skills and demonstrated ability to collaborate effectively and establish trusting relationships with key stakeholders (internally and externally).
- Ability to think critically and strategically: ability to pan-and-zoom as required by the situation; ability to apply ideas and learnings from one area to another.
- Manages assigned direct and/or indirect reports to support the implementation and execution of clinical trials. Mentors and develops direct reports to expand employee performance levels and assure retention of high performing employees.
- Some travel (domestic and international) will be required (approximately 10-15%).
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Associate Director, Clinical Operations - South San Francisco, United States - Cytokinetics, Incorporated
Description
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 Associate Director, Clinical Operations will provide leadership and efficient management of Clinical Operations activities to execute clinical trials in a manner that ensures that milestones and study quality targets are met, and costs are kept under control.
This position will oversee the activities of the CROs and other third-party vendors in the conduct and management of clinical trials.
This position will supervise and mentor Clinical Trials Managers and support staff in the start-up, conduct, and close-out of clinical trials.
ResponsibilitiesWe 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.
QualificationsWe 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.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$189,000-$231,000 USD
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:
Cytokinetics is an Equal Opportunity Employer
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