Director, Clinical Development Hepatitis

Director, Clinical Development Hepatitis

Director, Clinical Development Hepatitis United States - California - Foster City 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.

Ensure all your application information is up to date and in order before applying for this opportunity.

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

The Director , Clinical Development provides clinical leadership and input on clinical studies, support the hepatitis programs.

You will typically lead or assist on multiple components of clinical trial programs in Hepatitis clinical development. You will help design, conduct, and evaluate Phase 1-4 clinical trials and provide expertise in clinical hepatitis.

You will primarily be involved in developing drugs for HBV cure and HDV. Working in collaboration with the Clinical Leads and Global Development Team Leads, you will be responsible for various aspects of ongoing clinical trial program-related activities within the hepatitis therapeutic area.

These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up / execution / close out, specifically including, medical monitoring, data analysis / reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.

EXAMPLE RESPONSIBILITIES :

• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial proto col design, clinical study reports and 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.

• Manages the clinical development component(s) in the preparation / review of regulatory documents, 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.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

REQUIREMENTS :

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• Preference for MD / DO and 4+ years of clinical or biotech / pharma industry experience with a proven success record in clinical research studies, trial design, execution and oversight
• PharmD or PhD in clinical research or clinical pharmacology with 8+ years’ scientific and / or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Preference for applicants with experience in hepatitis D and / or B.
• Relevant experience in Hepatology is preferred.
• Experience in the biopharma industry is preferred.
• Experience working on cross-functional project teams in a global development team
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations is preferred.

Knowledge & Other Requirements

• 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.
• Proven analytical abilities as demonstrated through past experience and / or academic research.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Strong communication and organizational skills.
• When needed, ability to travel.

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

The Director , Clinical Development provides clinical leadership and input on clinical studies, support the hepatitis programs.

You will typically lead or assist on multiple components of clinical trial programs in Hepatitis clinical development. You will help design, conduct, and evaluate Phase 1-4 clinical trials and provide expertise in clinical hepatitis.

You will primarily be involved in developing drugs for HBV cure and HDV. Working in collaboration with the Clinical Leads and Global Development Team Leads, you will be responsible for various aspects of ongoing clinical trial program-related activities within the hepatitis therapeutic area.

These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up / execution / close out, specifically including, medical monitoring, data analysis / reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.

EXAMPLE RESPONSIBILITIES :

• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial proto col design, clinical study reports and 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.

• Manages the clinical development component(s) in the preparation / review of regulatory documents, 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.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

REQUIREMENTS :

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Preference for MD / DO and 4+ years of clinical or biotech / pharma industry experience with a proven success record in clinical research studies, trial design, execution and oversight
• PharmD or PhD in clinical research or clinical pharmacology with 8+ years’ scientific and / or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Preference for applicants with experience in hepatitis D and / or B.
• Relevant experience in Hepatology is preferred.
• Experience in the biopharma industry is preferred.
• Experience working on cross-functional project teams in a global development team
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations is preferred.

Knowledge & Other Requirements

• 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.
• Proven analytical abilities as demonstrated through past experience and / or academic research.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Strong communication and organizational skills.
• When needed, ability to travel.

The salary range for this position is : $237,660.00 - $307,560.00. 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 :

https : / / www.gilead.com / careers / compensation-benefits-and-wellbeing

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 [email protected] for assistance.

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

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For jobs in France :

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Job Requisition ID R0041570

Full Time / Part Time Full-Time

Job Level Director

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