Clinical Development Director, Biosimilars
ProClinical is partnering with a global healthcare company to advertise a vacancy for a Director of Clinical Development position. This organisation, which develops lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition, is seeking applicants for their team in Switzerland.
The Director of Clinical Development will lead clinical strategy/clinical development plans for the dedicated compounds, leads and oversees the direction, planning and interpretation of clinical trials or research activities within therapeutic area via internal and external parties
- Managing the design and implementation of one or more clinical programs /clinical studies in support of an overall Clinical Development Plan, based on strong medical and scientific principles.
- Overseeing CRO in terms of project-related education of investigators, study site personnel, and study staff related to the medical elements. Responsibility may extend from early development activities to mature product lifecycle management
- Participating in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall scientific strategy for internal and/or partnered programs, including external regulatory interactions
- Overseeing the medical aspects of the clinical study, including but not limited to, medical monitoring, protocol deviations, data integrity and review, interpretation, and the communication of accumulating data pertaining to safety and efficacy of the molecule.
- Managing the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures Clinical Study Reports, ISE, ISS, and paediatric plans as needed.
- Taking clinical leadership role in meetings with the regulatory organizations required to outline the Company position on research programs or regulatory applications.
- Leading as needed and contributing to the data disclosure plans including publications before approval.
- Acting as a clinical interface and actively soliciting opinion leader interactions related to the study; partnering with Medical Affairs, Commercial, and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into protocols as appropriate.
- Taking responsibility for the medical elements within CRO selection and RFPs.
- Staying abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the Biosimilars area.
- Adhering to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Owning respective SOPs and representing the function in audits/inspections
Skills and Requirements:
- An M.D. (Medical Doctor) qualification, with the completion of a subspecialty fellowship a desirable bonus.
- At least five years of clinical development experience in the pharmaceutical industry, preferably in biotechnology in a global role and having lead compounds to submission and approval with key agencies.
- Ability to interact externally and internally to support a global scientific and Biosimilars business strategy.
- Profound Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- 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.
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 Josh Volpe at + 44 203 800 1292 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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