Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of approximately 5,800 people is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in 16 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
One of the world’s most successful biotech companies with a current market capitalisation of over $120 billion, Gilead Sciences Inc. (www.gilead.com) is a leading research-based biopharmaceutical company which discovers, develops and commercialises innovative medicines in life-threatening diseases. Gilead’s primary areas of focus include HIV/AIDS, liver diseases, respiratory diseases, cardiovascular/metabolic diseases, inflammation and oncology.
In 26 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs in offices across four continents. Today, Gilead’s research and development effort is the largest it has ever been, with more than 200 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
An exciting opportunity has arisen to join Gilead’s International Drug Safety and Public Health team in Cambridge as Associate Manager, Drug Safety and Public Health.
Reporting to the Associate Director of Medical, Surveillance and Coding, you will be responsible for signal detection and authorship of signal work-up documents as well as production of CCDS sections and associated supporting documentation. Authorship of aggregate safety reports (e.g., PSURs), risk management plans, and responses to regulatory agency safety enquiries will also be a key focus. Working closely with Regulatory, you will compose responses to regulatory agency safety enquiries and contribute to safety analyses in Regulatory submissions (e.g., MAAs, NDAs). You will review global literature for potential safety concerns and carry out safety reviews of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies. You will have experience in core safety information versus local labeling and review standard reference documents and develop listedness/expectedness tables in collaboration with a safety physician.
The successful candidate will have a scientific background (PhD and/or post-doctoral experience in a life science field) or a degree (e.g., BS, BA, or MSc) or professional qualification in a life science field (e.g., nursing or pharmacy) and experience in the pharmaceutical industry, at a regulatory agency, or in clinical research. Good attention to detail, teamwork and initiative; as well as the ability to work to project deadlines in a confidential environment. The capacity to develop contacts globally within DSPH and across the company and use those contacts to manage projects more effectively. The capability of communicating effectively with functional peers and others within DSPH to ensure relevant parties are fully informed and knowledgeable of project activities and their status. Excellent organisational and interpersonal skills are vital. The candidate will also be flexible, adaptable and supportive of change as well as aligned with Gilead’s core values of integrity, team work, excellence and accountability.
Deadline: 13 March 2014