Director, Clinical Pharmacology and Pharmacometrics (Temporary Staff-R…
Vir BiotechnologySalary not specified
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Oncology, VirologyIndustries
Requirements
- PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years’ relevant pharmacometrics research or development experience OR
- Masters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 10+ years’ relevant pharmacometrics research or development experience OR
- Bachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 12+ years’ relevant pharmacometrics research or development experience
- Significant experience working on, with, and leading cross-functional project/program teams in life sciences (Preferred)
- Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and having responsibility for the scientific execution of related analyses across Phase I – IV studies (Preferred)
- Demonstrated excellence in effectively managing multiple pharmacometrics analyses deliverables and priorities through matrix management and leadership (Preferred)
- Relevant experience in the Oncology, Virology, and/or Inflammation Therapeutic Areas (Preferred)
- Proficiency in mathematics (Preferred)
- Demonstrated ability (Preferred)
Responsibilities
- Lead quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas across all stages of drug development from first-in-human through Phase IV clinical trials
- Conduct, interpret, and report quantitative analyses, and support regulatory filings
- Champion model-informed drug development (MIDD) across drug discovery and development
- Serve as a subject matter expert for modeling and simulation to cross-functional partners
- Lead quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle of the program
- Evaluate and apply state-of-the-art quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans in collaboration with key stakeholders
- Evaluate and apply strategy and content as appropriate
- Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions
- Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed
- Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Develop and present training within and outside the department as needed
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the minimum education and experience required for the Director, Pharmacometrics role?
A PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years of relevant pharmacometrics research or development is required.
What are the main responsibilities of this position?
The role involves leading quantitative analyses in Oncology, Inflammation, and Virology Therapeutic Areas across all drug development stages, championing model-informed drug development (MIDD), and serving as a subject matter expert for modeling and simulation.
Is this a remote position or does it require office work?
This information is not specified in the job description.
What is the salary or compensation for this role?
This information is not specified in the job description.
What does Gilead value in its employees and leaders?
Gilead values collaboration, determination, a relentless drive to make a difference, and strong people leadership that fosters an inclusive environment where employees feel developed and empowered.
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
