ProClinical is advertising a vacancy for a Director of Epidemiology position with a global biopharmaceutical company that prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas. Based in London, this position will allow an experienced and driven applicant to join an organisation whose pipeline of late-stage drug candidates and unmatched patient access programs ensure that medications are available to those who could otherwise not afford them.
The Director of Epidemiology will act within the Department of Pharmacovigilance & Epidemiology (PCE), and will design, direct, and execute observational studies, including pharmaco-epidemiological studies and non-interventional studies. They will maintain a thorough knowledge of epidemiological principles, analysis methods, and data resources, as well as indications for their appropriate use. The Director will interpret analysis results and lead preparation of study reports, conference abstracts, presentations, and manuscripts. Finally, the Director of Epidemiology will also demonstrate a thorough knowledge of statistical programming principles, analysis methods, and data resources, as well as indications for their appropriate use.
- Leading Epidemiology activities, designing, directing, and executing multiple observational studies to accomplish business objectives.
- Developing and/or reviewing protocols and Statistical Analysis Plans.
- Overseeing and/or actively contributing to the completion of analytical/validation activities for studies/projects, in collaboration with Epidemiology Programming.
- Overseeing and/or actively contributing to analysis/validation projects, utilising industry-standard analytic tools.
- Leading Epidemiology activities, including interaction with CROs, to accomplish business objectives.
- Leading special projects based on extensive knowledge base, experience, and competency.
- Providing epidemiologic input into Pharmacovigilance Plans and contributing to Risk Evaluation and Mitigation Strategy programs.
- Leading internal and external educational initiatives.
- Overseeing and actively contributing to the preparation and review of safety documents in response to regulatory authorities.
- Providing epidemiologic expertise across the organisation throughout product lifecycle.
- Overseeing the review, synthesis, and critique of the literature.
- Leading interpretation of analysis results, preparing study reports, conference abstracts, presentations, and manuscripts.
- Identifying, assessing, and integrating/implementing new data resources, methods, technology, and analytic tools.
- Actively contributing to identification and assessment of safety signals and trends using active surveillance methods.
- Leading intra-departmental and inter-departmental cross-functional project teams.
- Leading process improvement initiatives, including SOP/WRK updates and audits.
- Successfully interacting with other groups within PVE.
- Mentoring junior departmental staff to ensure competence in epidemiologic skills and knowledge.
- Participating in recruitment, hiring, and mentoring of direct reports, with responsibility for employee performance evaluations and professional development.
Skills and Requirements:
- A PhD in Epidemiology or related field.
- High proficiency in the field of Epidemiology.
- At least six years of relevant experience.
- Experienced in conducting observational studies and data analyses using real-world healthcare databases (e.g., non-interventional studies, electronic medical records, administrative healthcare claims, disease registries, national surveys, etc.) is highly desirable.
- An ability to build and maintain complex and efficient SAS routines using SQL, macros, and multi-processing techniques.
- Capable of writing and running code in Stata or R is a plus.
- Experience with using data visualisation tools, such as Spotfire and Tableau, is a plus.
- 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 with computer skills, such as MS Office.
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 Qas Shafi at +44 203 078 9569 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.
Welwyn Garden City, Hertfordshire
ProClinical is advertising a vacancy for a Brand Director Oncology position
£400.00 - £450 per day
ProClinical is advertising a vacancy for a GxP Quality Audit Manager position
Up to £0.00 per annum
ProClinical is advertising a vacancy for a Senior Director, Business Development position
ProClinical is advertising a vacancy for a QC Lab Tech position
Foster City, California
ProClinical is advertising a vacancy for an Event Planner II position
£0.00 - £140000.00 per annum
ProClinical is advertising a vacancy for a Regulatory Senior Director CMC position
£0.00 - £80000.00 per annum
ProClinical is advertising a vacancy for a Regulatory Senior Manager CMC position
ProClinical is advertising a vacancy for a Senior Manager Clinical Operations position