Sr Director, Medical Affairs & Clinical Research
Job Title: Sr Director, Medical Affairs & Clinical Research
Company: Confidential
Status: Full Time
Years of Experience: 6+Location: Napa Valley, CA
Description:
This position has overall responsibility for Pharmacovigilance, drug information, drug safety and clinical study protocols development. Oversees the direction, planning, execution and interpretation of safety data from clinical trials/research, safety data collection activities. Establishes and approves scientific methods for design of clinical protocols. Supports new and ongoing clinical research and clinical trials. Selects and interacts with CROs and other vendors.
-Directs activities of multiple functions focused on providing medical information to staff and outside healthcare professionals.-Responsible for providing medical input and consultation to address medical and drug safety issues on commercial products.
-Designs, develops, implement and oversees policies and procedures to assure meeting regulatory timelines for monitoring and reporting drug safety/Pharmacovigilance.
-Directs and manages Pharmacovigilence activities.-Directs and manages medical education and CME programs.
-Reviews unrestricted grant requests and coordinates Investigator initiated trials.
-Directs the designing and oversees the administration of clinical study protocols.
-Participates in the selection of clinical CRO.-Acts as spokesperson on medical and clinical issues.
-Oversees and/or participates in discussions with FDA and other regulatory agencies on medical and drug safety issues.
-Provides medical and clinical reviews for potential in-licensing candidates.
-Responds to medical and clinical inquiries on products from outside groups, physicians, agencies, etc.
-Lead company contact with FDA and other health authorities on drug safety and medical information.
-Directs and takes a leadership role in the design, modification, development and implementation of company practices and policies that affect drug safety and drug information.-Responds to requests for medical/drug information, both from internal and external customers.
-Takes a leadership role in the development of new products.-Directs and manages Adverse Effect (AEs) reporting to FDA and MGG.-Serves as a member of NPC.
-Provides medical education to MSLs and Sales & Marketing staff.
-Presents medical information on products at meetings with various state and Federal agencies and therapeutic committees.
Requirements:
MD, PharmD, or PhD from a U.S. recognized program. Training and experience in Drug Information and Pharmacovigilance. Training and experience in designing of clinical trials for the development of new drugs or dosage forms. Requires previous management and project experience.
Contact Information:
Contact Name: Kendra KhawajaContact Email: kendrak@nsasearch.com
Contact Phone: (760) 268-0377
Company: Confidential
Status: Full Time
Years of Experience: 6+Location: Napa Valley, CA
Description:
This position has overall responsibility for Pharmacovigilance, drug information, drug safety and clinical study protocols development. Oversees the direction, planning, execution and interpretation of safety data from clinical trials/research, safety data collection activities. Establishes and approves scientific methods for design of clinical protocols. Supports new and ongoing clinical research and clinical trials. Selects and interacts with CROs and other vendors.
-Directs activities of multiple functions focused on providing medical information to staff and outside healthcare professionals.-Responsible for providing medical input and consultation to address medical and drug safety issues on commercial products.
-Designs, develops, implement and oversees policies and procedures to assure meeting regulatory timelines for monitoring and reporting drug safety/Pharmacovigilance.
-Directs and manages Pharmacovigilence activities.-Directs and manages medical education and CME programs.
-Reviews unrestricted grant requests and coordinates Investigator initiated trials.
-Directs the designing and oversees the administration of clinical study protocols.
-Participates in the selection of clinical CRO.-Acts as spokesperson on medical and clinical issues.
-Oversees and/or participates in discussions with FDA and other regulatory agencies on medical and drug safety issues.
-Provides medical and clinical reviews for potential in-licensing candidates.
-Responds to medical and clinical inquiries on products from outside groups, physicians, agencies, etc.
-Lead company contact with FDA and other health authorities on drug safety and medical information.
-Directs and takes a leadership role in the design, modification, development and implementation of company practices and policies that affect drug safety and drug information.-Responds to requests for medical/drug information, both from internal and external customers.
-Takes a leadership role in the development of new products.-Directs and manages Adverse Effect (AEs) reporting to FDA and MGG.-Serves as a member of NPC.
-Provides medical education to MSLs and Sales & Marketing staff.
-Presents medical information on products at meetings with various state and Federal agencies and therapeutic committees.
Requirements:
MD, PharmD, or PhD from a U.S. recognized program. Training and experience in Drug Information and Pharmacovigilance. Training and experience in designing of clinical trials for the development of new drugs or dosage forms. Requires previous management and project experience.
Contact Information:
Contact Name: Kendra KhawajaContact Email: kendrak@nsasearch.com
Contact Phone: (760) 268-0377
posted by Alex at
11:08 PM
