Sr. Medical Director - Acerta
Location: Redwood City, California
Posted: April 25, 2017
Reference ID: 5000207597910
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 Senior Medical Director, Hematology oversees the direction, planning, execution, and interpretation of clinical trials and the data collection activities.
The Sr. Medical Director, Hematology is responsible for directing protocol implementation including site identification and communication, attendance at investigators' meetings, correspondence with sites including IRBs and interaction with operations teams. Managing program development, including working cross-functionally with all of 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. Interacting closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration. Monitoring clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff. Supporting data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts. Supporting commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team. Interacting closely with Medical Affairs in support of ISTs and publications. Interacting closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies.
* MD or MD/PhD
* Minimum three years of industry experience
* Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
* Demonstrated independence, initiative and the ability to work well in a fast-paced environment
* Travel time is approximately 15% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings
* Subspecialty training in oncology and/or hematology
* Outstanding academic achievement and significant clinical trial experience
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