Associate Director, Clinical Operations - Oncology
Associate Director, Clinical Operations - Oncology
United States - Washington - Seattle
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
Associate Director, Clinical Operations - Oncology:
*Located in Seattle, WA
Specific Responsibilities and Skills for Position:
- Must meet all requirements for CPM position and have demonstrated proficiency in all relevant areas
- Provides leadership and therapeutic expertise for the successful management of international clinical trials
- Contributes to the strategic implementation of a clinical development program(s)
- Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required
- Must possess a proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
- Extensive experience in developing RFPs, selection of CROs/vendors and management of external resources is required
- Ability to initiate, participate in and/or lead departmental or interdepartmental strategic initiatives
- Participates in development of SOPs, Clinical Study Reports, INDs, NDAs and other clinical, regulatory and safety documents
- Provides input into the management of the Clinical Operations department
- Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Recruits, hires, mentors and manages CTM/CPM direct reports and supports their professional development
- Leads cross-functional study management team and should have good influencing skills with study stakeholders
- Travels nationally and internationally as required
- Excellent interpersonal skills, ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required
- Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and non-interventional studies
- Proven ability for successful study implementation and completion
- Financial Accountabilities for Clinical Trial Budgets
- Recognizes and escalates critical issues in a trial that may impact the strategic business or financial goals of the Company's overall business
- Ability to motivate teams and drive performance
Experience and Skills:
- At least 10+ years of experience and a BS or BA in a relevant scientific discipline
- At least 10+ years of experience and an RN (2 or 3 year certificate)
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---Washington---Seattle/Associate-Director--Clinical-Operations---Oncology_R0019018-1
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