Ruderfer & Associates
Biopharmaceutical Search Consultants

#2103

Associate Director, Clinical Research - Neuroscience

 Position:                 Associate Director, Clinical Research - Neuroscience         Job # 2103

Location                    Northern, NJ

Compensation         Based upon Experience

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Job Summary:

The Associate Director, Clinical Research is a newly created role for a dynamic individual with an PhD with experience in the pharmaceutical industry. The position is intended to provide the organization with an individual to oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and, in particular, Alzheimer’s Disease. Additionally, this individual 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 performing medical monitoring for these and, possibly, other studies within the Neuroscience Business Group.

Duties & Responsibilities:

  • 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

Qualifications:

  • PhD, ideally focused in Neuroscience or a related area with prior pharmaceutical industry clinical research experience

  • PhD candidates will be considered at Associate Director level with 4+ 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

  • Knowledge of GCP and local regulatory requirements

  • Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience

  • Knowledge of medical, scientific and clinical research techniques in the neurology/psychiatry therapeutic area

  • Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology

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