Senior Medical / Scientific Director

Member of Horizon s clinical development teams, contributing to the design, analysis and reporting of clinical studies. Activities to include protocol writing, study conduct oversight according to best practice and national and international guidelines and regulations, as well as Horizon's objectives and standard operating procedures (SOPs). Data analysis support and data interpretation with data representation to internal and external (regulatory) audiences is a core skill set requirement. Experience in collaboration with statistics and clinical pharmacology colleagues is required. Work closely with the Therapeutic Head of Rheumatology VP role to ensure robust clinical development plans, robust protocols and appropriate study oversight. Ability to interact with Chief Scientific Officer and Chief Medical Officer for medical decisions as needed. Standing member of clinical trial and post marketing safety review groups as well as the product development teams. Provide input into and review key internal and external reports such as Investigator Brochure, Risk Language, Informed Consent, study Protocols, study operations manuals, etc. Proven success in regulatory interactions, over a 2-5 year time frame, with both written and face-to-face interactions with regulatory agencies. Candidates with global regulatory agency experience will be preferred. Candidates with experience in IND and NDA/BLA filings will be preferred. Demonstrated ability to manage KOL as part of study protocol designs. Demonstrated ability to interact with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed. Contribute as needed to key safety documents, in collaboration with PSPV and regulatory colleagues including the PADER, PSUR, DSUR, etc. Provide clinical-scientific input into the development of Product Labels, core company data sheets (CCDS), Risk Evaluation and Mitigation Strategy and Risk Management Plans. Provide guidance to managers before, throughout, and following clinical trials to  ensure compliance for proper study conduct throughout clinical trials Review data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, ECGs, as required in collaboration with PSPV colleagues; liaise with Safety Data Monitoring Board, if applicable Review of non-clinical data as required. Review of clinical pharmacology data as required. Review of post-marketing safety data as required to inform label language and to support internal and external company reviews of the product safety profile. Participate in evaluation of life cycle management opportunities including assessment of adjacent indications, assessment of investigator initiated trial proposals, etc. Support development of medical affairs materials, based on clinical trial datasets. Participate in due diligence activities as requested. Education & Professional Experience A degree in medicine, pharmacy, or advanced training in the sciences (PhD) with 5-10 years of biotech/pharmaceutical experience in clinical development related activities. Demonstrated ability to work cross functionally in a matrixed environment. Experience in supervising others is not an expected skill but will be considered.  Essential Core Competencies: Ability to work independently as well as cross-functionally Results and Action Oriented Ability to Deal with Ambiguity Ability to organize teams around focused task resolution Demonstrated Strategic and Problem Solving in matrixed environment Demonstrated Functional and Technical Skills for Clinical Development R0000691
Salary Range: NA
Minimum Qualification
5 - 7 years

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