Clinical Development Director - Biosimilars
ProClinical is advertising a vacancy for a Clinical Development Director - Biosimilars position with a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. This organisation, whose products and services are used to care for critically and chronically ill patients, is seeking for an experienced and driven applicant to join their team in Geneva.
The Clinical Development Director - Biosimilars will lead clinical strategy/Clinical development plans for the dedicated compounds, as well as lead and oversee 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 CROs 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 communication of accumulating data pertaining to safety and efficacy of the molecule.
- Overseeing the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures Clinical Study Reports, ISE, ISS, and paediatric plans as needed.
- Acting as the clinical leadership in meetings with the regulatory organisations 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.
- Being accountable 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.
- Ensuring adherence 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
- Interacting proactively with other clinical and non-clinical functions.
Skills and Requirements:
- An M.D. degree, with the completion of a subspecialty fellowship a desirable bonus.
- At least 5 years of clinical development experience in the pharmaceutical industry, preferably in biotechnology in a global role and having lead compound(s) to submission and approval with key agencies.
- Capable of leading and managing complex research/clinical research projects with minimal supervision.
- Capable of assessing risk and making risk-based decisions to balance the stakeholder needs.
- A strong knowledge of clinical trial methodology.
- A profound knowledge of regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
- 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.
- Prepared to work hard to meet ambitious deadlines and exceed clients' expectations
- Proficiency in 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 Tom Russell at +44 203 824 6104 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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