Director Clinical Development
Posted on Mar 17, 2019 by Hobson Prior
The biosimilars division is a new acquisition. with 170 employees the division can act and feel like a small company whilst benefitting from being part of a larger growing group. More like a start-up environment. This role will offer greater independence and autonomy than is typical of large pharma.
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.
Physician preferable, PhD and Pharmacists considered
+5 years Clinical development experience
Experience in the clinical development of auto-immune therapeutics, 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.
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