Associate Clinical Pharmacology Director
Job
Gilead Sciences
Foster City, CA (In Person)
$224,445 Salary, Full-Time
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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.
Specific Job Responsibilities:
As a member of a drug development team, routinely provides input into product development strategies and/or research or clinical development plans for assigned products / projects. Authors the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area. Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, which includes responsibilities for leading the respective cross-functional study team. With input from others, designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans. Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design. Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies. Addresses clinical issues arising from clinical pharmacology studies. Directs the activities and resources for both internal and external study partners. Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies. Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific presentations or literature. Analyzes, interprets and authors documents for clinical and regulatory submissions. Presents project updates and other key milestone information to cross-functional partners and stakeholders. May support business development / due diligence activities as a clinical pharmacology expert. Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies. Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking. Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.Basic Qualifications:
Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience Preferred Qualifications:
PhD or PharmD in pharmaceutical sciences, pharmacology or related discipline Excellent verbal, written, and interpersonal communication skills and ability to convey complex technical information clearly to others are required. Experience using pharmacokinetic program and analysis software (such as WinNonlin) Experience leading small cross-functional project teams and managing clinical project deliverables through matrix management Significant experience leading clinical pharmacology study concept and protocol design, authoring clinical pharmacology development plans, Experience contributing to regulatory filings is strongly preferred Experience supporting clinical publications and presentations Demonstrate ability to be a fast learner. Demonstrate ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies. Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology. Demonstrate ability to effectively apply business acumen to strategic scientific projects. When needed, ability to travel.People Leader Accountabilities:
Create Inclusion- knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent
- understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams
- connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.
Bay Area:
$195,670.00- $253,220.
Other US Locations:
$177,905.00- $230,230.
United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. 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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