Sr. Associate Clinical Development Director
United States - New Jersey - Morris Plains
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
Gilead has declared Hematology-Oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune oncology through internal research, partnerships and acquisitions. This role provides an exciting opportunity to participate in the future growth of Gilead Oncology. This role will play a key role in development of pipeline programs and will support evaluation of internal and external opportunities for expanding the pipeline.Specific Responsibilities:
This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for Oncology. This Director, Clinical Research position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical Oncology. Essential Duties and Job Functions:
Knowledge, Experience and Skills:
- Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
- Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
- Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
- Coordinates the collection and assimilation of ongoing data for internal analysis and review.
- Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings.
- Leads two or more specific components of cross-functional strategic initiatives.
- Excellent scientific written and oral communication skills are required.
- Must possess a proven ability to work highly effectively with multiple departments.
- Must be capable of working with attention to detail in a time sensitive environment.
- 8+ years of relevant experience in clinical research with a PhD or BS/MS degree with extensive industry experience.
- Strong familiarity with good clinical practices.
- Familiarity with clinical Oncology preferred
- Clinical or translational research experience preferred
- Pharmaceutical/Biotech industry experience in clinical development preferred but not required
- Successful leadership and management experience
- Excellent organizational and communication skills are essential
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.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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