Location:Redwood City, California, United StatesJob reference:
Sep. 15, 2016
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 Associate Director, Medical Safety Science will participate in the development and review of appropriate safety sections of key safety documents including: IBs, CSRs, protocols, ICF, RSI, CDS, participate in the preparation of DSURs, IND Annual Reports, PSURs/PBRERs, and other global periodic safety reports, and participate in and support management of medical review of individual case safety reports (ICSRs) for Acerta products throughout the life cycle, including review of SUSARs and IND Safety Reports, and including generation of Analysis of Similar Events as needed.
In addition, during medical review, the Associate Director, Medical Safety Science will support Quality Control for of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database. You will ensure that the medical review workflow step for all safety reports received from any source are processed within timeframes that maintain compliance with ICH-GCP guidelines, regulatory requirements and company SOPs and procedures, and monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems.
* Masters in life sciences
* Ability to travel both domestically and internationally (<30%)
* Minimum of eight years of drug safety, clinical research, or healthcare related experience
* A minimum of two years must be derived from pharmaceutical industry experience directly related to adverse event reporting from clinical trials
* Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
* MD; PharmD; Nursing /RN
* Global experience is preferred. Oncology experience is a plus
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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.