Clinical Program Manager
- Experience Level
Hobson Prior is seeking a Clinical Program Manager to join a global biopharmaceutical company based in the UK. A very patient-focused company, whose scientific research has resulted in 15 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.
- Responsible to manage all aspects of the conduct of assigned clinical studies within budget and timelines (this includes protocol development, feasibility, set-up and conduct, CRO selection and oversight and reporting according to the organisations SOPs and appropriate national and/or global regulation and legislation.
- Co-operate with colleagues in Clinical Operations, Medical Affairs, Drug Safety, Project Management, Regulatory and Clinical Research within the EU and US to ensure delivery of assigned studies as well as support assessment and tracking of trials.
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
- Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
- Strong interpersonal skills and demonstrated ability to lead is required.
- Excellent communication and influence skills and ability to create a clear sense of direction is necessary.
- Fluent in English both oral and written communication (however proficient in another European language would be admirable).
- Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents with minimal supervision.
- BSc Life Sciences (MSc* or PhD would be admirable).
- A minimum of 10 years relevant clinical experience in the pharmaceutical industry.
- Experience in clinical study management and project oversight is essential.
- Previous line management experience or experience in mentoring and developing junior staff would be preferred.
- Knowledge of regulatory affairs and drug safety.
- Experience in developing RFPs and selection and management of CROs/vendors.
- In-depth knowledge of ICH GCP, FDA and EMEA regulations & guidelines.
- Knowledge of drug development & commercialisation processes.
- Therapeutic area (Inflammation) experience especially Rheumatoid Arthritis indication is preferred however not essential.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.