Director/Senior Director - Clinical Pharmacology and Pharmacometrics - Acerta - Redwood City, CA | Biospace
Get Our FREE Industry eNewsletter

Director/Senior Director - Clinical Pharmacology and Pharmacometrics - Acerta

AstraZeneca Pharmaceuticals LP

Apply
Location:
Redwood City, CA
Posted Date:
9/24/2017
Position Type:
Full time
Job Code:
5000237957510
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Redwood City,
California,
United States
Job reference: 5000237957510

Posted date: Jul. 17, 2017



Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.

Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.

The Director/Senior Director -- Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology and pharmacometric modeling and simulation to Acerta project teams.

Acerta Pharma (a member of the AstraZeneca Group) has a fast-paced, interactive, science-driven work environment that will require a willingness to lead on new challenges and to work cross-functionally to achieve corporate goals.

* Work closely with Acerta Research and Early Development, Acerta Development, and with AstraZeneca as a leader and subject matter expert in oncology quantitative pharmacology and pharmacometric modeling and simulation.
* Apply pharmacokinetic/pharmacodynamics (PK/PD) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.
* Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical and preclinical studies, maintain study records and ensure study completion along program timelines.
* Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.

Requirements:

* PhD or PharmD with 10+ years' experience as a Clinical Pharmacologist/Pharmacometrician in the pharmaceutical industry or related field/experience.
* Excellent written and oral communication, interpersonal and problem solving skills.
* Experience in oncology and immuno-oncology model development is essential, experience in translational aspects of hematology/oncology drug development is preferred.
* Ability to inspire and lead a group of pharmacometricians and clinical pharmacologists.
* Manage multiple projects under tight timelines working both independently and collaboratively on teams.
* Experience managing data transfer processes and timelines.
* Experience writing clinical pharmacology/pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control.
* Knowledge of regulatory requirements governing drug development.
* Resourcefulness, pragmatism, creativity and an independent work ethic.

Preferred:

* Extensive experience in noncompartmental analysis and pharmacometric modeling and simulation including use of WINNONLIN and NONMEM or similar statistical modeling software.
* Knowledge of R, SAS, MATLAB or similar modeling software and substantial experience building NONMEM datasets.

Next Steps -- Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

~bsp

Requirements

Please See Description