Senior Director Clinical Compliance and Training
Senior Director Clinical Compliance and Training
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$ 261000 - 319000
1 Vacancy
Job Description
Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass 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.
At Cytokinetics each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious compassionate and collaborative individuals who are driven to make a positive impact.
Job purpose
The Senior Director Clinical Compliance & Training will provide GCP/ICH quality leadership and strategic development of quality initiatives supporting a quality culture in the of Cytokinetics clinical development programs. This person will provide guidance and support forDevelopment Operations including oversight of clinical quality activities and ensure clinical trials are conducted in a manner compliant with SOPs ICH/GCP/regulatory guidelines and company goals.
Responsibilities
Strategically lead the Clinical Compliance & Training function to deliver knowledge training oversight guidance and support to promote and maintain GCP compliance for the operation and of Cytokinetics clinical development programs.
Be the SME for Development Operations personnel for issues relating to GCP noncompliance surveillance Quality Events audit/inspection responses and process optimization
Track quality issues deviations and corrective actions ensuring effectiveness and delivery
Partner with Development Operations personnel in Root Cause analyses and advises on content of CAPAs and audit/inspection responses
Drive the design development and of development and training programs to support process quality and inspection readiness
Evaluate business unit needs to design develop and implement annual training plans for Clinical Development departments
Partner with Clinical Operations Quality Assurance Data Management Biostatistics Statistical Programming Medical Science Drug Safety and Pharmacovigilance and Corporate Compliance to manage studyspecific training and ensure adherence to GCP compliance
Partner with Clinical Quality Assurance on remediation of quality issues related to clinical study conduct. Act as a liaison with Clinical Quality Assurance to ensure coordination and communication of quality driven initiatives to ensure alignment on compliance decisions and recommended actions implementation
Qualifications
ICH/GCP expert with a strong understanding of FDA and EMEA regulations related to clinical development
BA/BS in sciencerelated field. 15 years work experience including Clinical Operations and Quality Assurance
Highly experienced as a Trainer Training Facilitator or similar role
Advanced experience coordinating training events in a corporate setting
Adequate knowledge of learning management systems and web delivery tools
Excellent communication skills (verbal and written) including interpersonal skills with demonstrated successful team participation
Experience in Root Cause Analysis methodologies and CAPA management
Experience in supporting clinical trial GCP compliance/quality management activities and initiative
Strong understanding of drug development and clinical trial including cross functional areas involved in clinical trials
Experience in supporting GCP inspection readiness activities and participated in regulatory authority inspections
Strong leadership abilities to inspire and motivate others to achieve results
Strong analytical and problemsolving skills with the ability to collect and analyze data to inform talent management decisions
Exceptional organizational and project management skills with the ability to manage multiple priorities and meet deadlines
Ability to adapt to a fastpaced and changing environment and drive change within the organization
This position requires an onsite presence at South San Francisco remote work not supported.
Pay Range:
In the U.S. the hiring pay range for fully qualified candidates is $261000 $319000 USD Annual per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidates geographic region jobrelated knowledge skills and experience among other factors.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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through nonstandard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at
Cytokinetics is an Equal Opportunity Employer
Required Experience:
Exec
Employment Type
Full-Time
