Regulatory Affairs Director CMC Biologics

A leading biotechnology company is seeking to recruit a Regulatory Affairs Director, CMC Biologics to their office in London. The company is known for their work in developing therapeutics that treat rare genetic diseases, some of which affect as few as 1000 people worldwide. This is an exciting opportunity to join a dynamic global business and support its commercial presence across Europe, along with other regions.

Job Responsibilities:

• Coordinating Real World Evidence needs and providing technical expertise in Epidemiology methods to develop and maintain a Real World Evidence strategy to support products from clinical development through licensing, market access, and lifecycle management. Specific activities include:
• Understanding Real World Evidence needs at the functional level and determine a plan of action to utilise existing Epidemiology evidence or conduct de novo retrospective and prospective research protocols to best address targeted research queries.
• Improving disease understanding relevant to the target patient population: incidence, prevalence, risk factors, natural history, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, phenotypes, biomarkers and unmet need, and their variations across demographics and geographies.
• Supporting post-marketing activities including design of post-marketing safety and effectiveness studies/registries, Epidemiology studies for safety signal detection, evaluation of risk mitigation strategies.
• Evaluating and monitoring of literature in the therapy area as well as advancements in Epidemiology methods and policy/acceptance of Real World Evidence by regulators/payors
• Developing and negotiating research plans with external collaborators in academia or contract research organizations and work effectively to oversee external groups through the research process.
• Effectively communicating observational methodology principles and study findings to an internal and external audience base.
• Contributing to the development of SOPs, guidelines, and templates to support conduct of Epidemiology & Real World Evidence studies.

Skills and Requirements:

• Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry.
• Self-motivated with the ability to develop credibility with colleagues and interact effectively and lead multi-disciplinary matrix teams.
• Experience in collaborating with research partners.
• Ability to work well in a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills.
• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.
• Record of high quality, peer reviewed Epidemiology or outcomes research publications preferred.
• Experience in the Epidemiology of rare diseases or Genetic Epidemiology a benefit.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency in computer skills, such as MS Office.

Education:

A combination of academic training and practical experience in Epidemiology is required. This may consist of:

• Doctoral degree (PhD, ScD, or DrPH) or Master's of Public Health in Epidemiology and at least 5 years of experience leading epidemiologic research in the pharmaceutical setting.
• Doctoral degree (PhD, ScD or DrPH) or Master's degree in a relevant discipline (ie. Health services research, health outcomes research, public health, statistics, or pharmaceutical sciences) with at least 8 years of experience leading epidemiologic research in the pharmaceutical setting.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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