Sr. Associate Clinical Development Director

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. Gilead’s 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 company’s five core values. That’s 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

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Essential Duties and Job Functions:

• Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
• Participates in protocol review discussions concerning scientific and procedural aspects of study design.
• Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
• With supervision, contributes to start up activities, including but not limited to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
• With supervision, addresses questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs
• With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities.
• Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
• Supports priorities within functional area.
• Plays a leadership role in the development and implementation of communications strategies to support existing and concluded studies.
• May be asked to coordinate teams and provide direction.
• May lead two or more specific components of departmental strategic initiatives.
• Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
• Completes and/or leads other special projects, as and when assigned, or otherwise requested
• Consistently complies with all governing laws, regulations, Gilead Standard Operating Procedures (SOPs) and other guidelines
• Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
• May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.

Knowledge, Experience and Skills:

• Advanced degree such as MD, PharmD or PhD with at least 2 years of experience in clinical development in a pharmaceutical company, contract research organization or academic institution is preferred.
• 5+ years of relevant scientific and/or drug development experience with a MS.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Outstanding written communication skills
• Strong presentation skills: highly effective at summarizing and presenting the key considerations and decision-points

Preferred Skills:

• Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on-point, and is able to raise problems or challenges in a productive and mature manner
• Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire

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 careers@gilead.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

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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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:
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