ProClinical is partnering with a global healthcare company to advertise a vacancy for a Clinical Development Director - Biosimilars position. The organisation specialises in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company's products and services have been used to help care for critically and chronically ill patients. Based in Switzerland, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
The Clinical Development Director will lead clinical strategy/Clinical development plans for the dedicated compounds, lead and oversee the direction, planning and interpretation of clinical trials or research activities within therapeutic area via internal and external parties.
Job Responsibilities:
- Manages 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.
- May oversee 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
- Participates 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
- Has accountability and responsibility for oversight of 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.
- Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures Clinical Study Reports, ISE, ISS, 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.
- Leads as needed and contributes to the data disclosure plans including publications before approval.
- Acts as a clinical interface and actively solicits opinion leader interactions related to the study; partners 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.
- Is accountable and responsible for the medical elements within CRO selection and RFPs.
- Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the Biosimilars area.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Owns respective SOPs and represents the function in audits/inspections.
- Interact proactively and solution orientated with other clinical and non-clinical functions.
Skills and Requirements:
- Education: Medical Doctor (M.D.). Completion of a subspecialty fellowship is desirable.
- Work experience: At least 5years of clinical development experience in the pharmaceutical industry preferably in biotechnology in a global role having lead compound(s) to submission and approval with key agencies.
- Ability to lead and manage complex research/clinical research projects.
- Ability to assess risks and take risk-based decisions balancing the stakeholder needs.
- 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.
- Demonstrated project management skills.
- 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.
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 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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