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Medical Director Neurology

Reference Number: 3217
Location: MA

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for a Medical Director, Neurology.

Major tasks and responsibilities will include:

  • Develops the clinical strategy and integrated development plan for our program, and work cross-functionally to implement, manage, interpret and communicate the results of clinical trials.
  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports.
  • Leads and supervises clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverables of clinical trials under his/her direct responsibility.
  • Serves as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
  • Responsible for analysis of clinical data, including safety monitoring in collaboration with PV.
  • Develops and maintains relationships and serves as the main medical liaison with key opinion leaders and PIs.
  • Organizes and presents at relevant clinical advisory boards, DMC’s and medical/scientific meetings.
  • Supports R&D management and the commercial team with input on clinical development issues related to our commercial plan, and supports the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities.
  • Helps ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs.

We seek candidates with the following qualifications:

  • MD degree with Board Certification in Neurology or comparable training, and recognized expert within his/her field.
  • 1-5+ years of relevant clinical research experience with at least some in industry.
  • Experience in the biopharmaceutical industry preferred; substantial experience working on industry-sponsored trials will be considered.
  • Must possess a thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
  • This person must have strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
  • This person must have knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3217. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.