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Director, Clinical Development

3 months ago

Santa Monica, California, United States Gilead Sciences Full time
Director, Clinical Development – Clinical Scientist

Director, Clinical Development – Clinical Scientist

United States - California - Santa Monica, United States – Remote

Clinical Development & Clinical Operations

Regular
Job Description

At Gilead, we're creating a healthier world for all people.

For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Job Description

As part of the Clinical Development Department, the

Director, Clinical

Development


fills a key role ( Clinical Scientist ) on the clinical study team within one of Kite's cellular therapy programs.

Working in close collaboration with the study medical monitor, you will provide scientific guidance and support to the team.

You will be responsible for various aspects of clinical study execution including protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings.

Responsibilities
Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies

Acquires and utilizes knowledge of clinical trial design and relevant disease indications to assist in study concept and protocol development.

Contributes to discussions concerning scientific and procedural aspects of study design. Coordinates with other departments to produce the final protocol and informed consent documents.
Contributes significantly to the development of CRFs, edit checks, IVRS specifications, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis
Designs patient profiles and writes accompanying medical data review rules
Leads data cleaning effort in preparation for dose escalation or DSMB meetings, as applicable to study stage
Organizes and manages external medical advisory committees for the study team such Scientific Steering Committees, as instructed by the medical monitor
Researches and summarizes scientific information available in published literature for continual self-learning and to prepare training, study manual, or investigator meeting materials
Contributes to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data
Addresses site questions regarding protocol and related scientific issues and attends site initiation visits (SIVs)
Assists in writing or reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documents
Supports priorities within the functional area and contributes to or supports department initiatives as requested
Trains other clinical scientists as needed
Basic Qualifications
Doctorate and 8+ years of scientific and/or drug development experience
OR
Master's and 10+ years of scientific and/or drug development experience
OR
Bachelor's and 12+ years of scientific and/or drug development experience
OR
High School Diploma/GED and 16+ years of scientific and/or drug development experience

Preferred Qualifications
Advanced degree (PharmD, PhD, MS, etc.)
Experience in a clinical science role, in a hematology/oncology indication, and on global phase 2 and 3 studies
Able to translate technical concepts into accessible language and direction for the broader study team
Flexible and adaptable to quickly changing priorities, and willingness to move between projects to provide support/expertise as business needs dictate
Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as J-Review and Medidata Rave or similar
Thorough understanding of ICH GCP, as well as general knowledge of industry practices and standards
Excellent interpersonal, organizational, written, and verbal communication skills
Ability to work effectively on teams with a combination of remote and office-based team members
Exemplify our core values of integrity, accountability, teamwork, excellence, and inclusion
#LI-ML1

The salary range for this position is: $216, $279, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary.

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

Job Description

At Gilead, we're creating a healthier world for all people.

For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Job Description

As part of the Clinical Development Department, the

Director, Clinical

Development


fills a key role ( Clinical Scientist ) on the clinical study team within one of Kite's cellular therapy programs.

Working in close collaboration with the study medical monitor, you will provide scientific guidance and support to the team.

You will be responsible for various aspects of clinical study execution including protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings.

Responsibilities
Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies

Acquires and utilizes knowledge of clinical trial design and relevant disease indications to assist in study concept and protocol development.

Contributes to discussions concerning scientific and procedural aspects of study design. Coordinates with other departments to produce the final protocol and informed consent documents.
Contributes significantly to the development of CRFs, edit checks, IVRS specifications, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis
Designs patient profiles and writes accompanying medical data review rules
Leads data cleaning effort in preparation for dose escalation or DSMB meetings, as applicable to study stage
Organizes and manages external medical advisory committees for the study team such Scientific Steering Committees, as instructed by the medical monitor
Researches and summarizes scientific information available in published literature for continual self-learning and to prepare training, study manual, or investigator meeting materials
Contributes to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data
Addresses site questions regarding protocol and related scientific issues and attends site initiation visits (SIVs)
Assists in writing or reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documents
Supports priorities within the functional area and contributes to or supports department initiatives as requested
Trains other clinical scientists as needed
Basic Qualifications
Doctorate and 8+ years of scientific and/or drug development experience
OR
Master's and 10+ years of scientific and/or drug development experience
OR
Bachelor's and 12+ years of scientific and/or drug development experience
OR
High School Diploma/GED and 16+ years of scientific and/or drug development experience

Preferred Qualifications
Advanced degree (PharmD, PhD, MS, etc.)
Experience in a clinical science role, in a hematology/oncology indication, and on global phase 2 and 3 studies
Able to translate technical concepts into accessible language and direction for the broader study team
Flexible and adaptable to quickly changing priorities, and willingness to move between projects to provide support/expertise as business needs dictate
Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as J-Review and Medidata Rave or similar
Thorough understanding of ICH GCP, as well as general knowledge of industry practices and standards
Excellent interpersonal, organizational, written, and verbal communication skills
Ability to work effectively on teams with a combination of remote and office-based team members
Exemplify our core values of integrity, accountability, teamwork, excellence, and inclusion
#LI-ML1

The salary range for this position is: $216, $279, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary.

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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

for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights'

poster.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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Job Requisition ID

R0040822
Full Time/Part Time

Full-Time
Job Level

Director
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