​Director of Clinical Development - Neurology rare disease

Location New York
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Excellent salary benefits, bonus and long-term incentive plan
Contact name: Stuart Gilboy

Contact email: stuart.gilboy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21426
Published: about 1 month ago
Expiry date: 09 May 2021

A major international pharma business which is dedicated to researching effective treatments in Alzheimer’s and difficult to treat rare neurological diseases including Multiple Sclerosis and Parkinson’s are looking for a Director of Clinical Development, Neurology rare disease.

Job Summary

The Director of Clinical Development is a newly created role for a dynamic individual with clinical leadership experience in the pharmaceutical industry. The position is intended to provide the organization with a qualified individual to design and oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and, in particular, Alzheimer’s Disease. Additionally, you will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring for these.

Essential Functions

Assisting the project team clinical lead in planning, implementation, managing and reporting of CDPs and programs.

  • Developing Clinical Protocols to meet the objectives of the CDP. Serving as a Study Director for selected trials and delivering final protocol, implementation strategy and clinical data review plans.

  • Depending on credentials, the hired candidate may serve as a medical monitor and provide input into clinical issues, adverse events, laboratory data, patient inclusion/exclusion criteria.

  • Identifying, monitoring and resolving clinical program/trial issues, and reporting progress to management.

  • Serving as the SME to provide input to project teams across functions, presenting at Advisory Board meetings, and liaising with KOLs regarding protocol study strategy and issues.

  • Interpreting study data and developing integrated summaries of safety and efficacy. Participating in the selection of new compounds for clinical development and IND filings in Neuroscience (especially in the area of dementia therapeutics) through technical evaluation of licensing and/or partnering opportunities. This includes developing and implementing paradigms for novel data analyses.

Requirements

  • MD candidates with 3+ years of industry clinical research experience in Neuroscience. PhD candidates with 8+ years in clinical research in the pharmaceutical industry, preferably with experience in Neuroscience and especially Dementia (e.g., Alzheimer’s disease).

  • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation.

  • Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action.

For more information on this role please forward an up-to-date resume to stuart.gilboy@rbwconsulting.com. The role is based in New Jersey but of course it is worked remotely at present and likely in the long term so our client will invite clients form across the US.

Excellent salary benefits, bonus and long-term incentive plan