Clinical Scientist- Acerta
Location: Redwood City, California
Posted: May 30, 2017
Reference ID: 5000224164810
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 Clinical Scientist supports the Medical Director with oversight for the direction, planning, execution, and interpretation of clinical trials and related data collection activities.
The Clinical Scientist is responsible for supporting the Medical Director with protocol implementation including site identification and communication, attendance at investigators' meetings, correspondence with sites including IRBs, and interaction with operation's teams. Supporting program development, including cross-functional interaction with all the disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilance, and clinical operations. Supporting data compilation for efficacy and safety evaluation, with Medical Director oversight and review. Supporting interim response determination of patients on study, with Medical Director oversight and review.
Additionally, the Clinical Scientist will be working closely with the Medical Director, project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, IND and other regulatory submissions, protocol development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications and key clinical lead in cross-functional sub-team meetings in collaboration with the Medical Director. Author, develop, and amend clinical study protocols, consent forms, case report forms and ancillary documents in collaboration with the Medical Director and study teams. Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock. Work with the Medical Director in preparation of abstracts, posters, oral presentations and manuscripts. Work with the Medical Director and compound leader in preparation for, and organization of, development advisory boards.
* BS/MS/PhD (Advanced degree preferred) with a minimum three years of industry experience
* Subspecialty training in oncology and/or hematology preferred
* Outstanding academic achievement and significant clinical trial experience preferred
* Demonstrates effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
* Demonstrated independence, initiative and ability to work well in a fast-paced dynamic environment
* Ability to travel (approximately 15% ) to investigative sites, regulatory agencies, and to attend major oncology meetings
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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.