Medical Director, Clinical Research

Lawrence Harvey


Job ID :

13115


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Medical Doctor


Address 1 :

North America,--Texas,Texas,


Key Skills :

Medical Director, Clinical Research


Salary :

Negotiable


Date Posted :

03 Oct, 2018



Company Name :

Lawrence Harvey


Location1 :

Texas




Job Category :

Biotech Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

The (M.D.) Clinical Research Medical Director, in US Clinical Development & Medical Affairs, will provide a high level of medical expertise in the area of Clinical Drug Development in the Immunology & Dermatology area.

Primary medical responsibility for Development Clinical Trials - this includes protocol feasibility, physician to physician contact, protocol training, medical issue/question management, safety review and local regulatory interaction. May be called upon to provide strategic medical input for a given therapeutic area into protocol design at a global level. Identify/involve investigators and key opinion leaders in order to exploit the value of the as signed project(s) in the contest of the investigational product(s). Discussion with key opinion leaders regarding compounds in early development.



* Provide medical expertise specific to US.
* Lead and/or perform protocol, country and site feasibility.
* Provide consolidated feasibility and site selection input to global and US teams.
* Provide protocol, Risk management plan & disease training as appropriate at Investigator's Meetings or scientific venues or internally.
* Perform local AE review and provide general medical support for safety issues:
* Provide medical expertise support to pharmacovigilance activities.
* Be aware of clinical trial SAEs on a country level.
* Follow-up with the Investigator for additional information or clarifications as needed.



Additional responsibilities:

* When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc.
* Review and try to resolve local medical issues / questions that arise during the entire course of the study
* Assist in writing country or site specific Informed Consent Forms (ICF).
* Provide strategic medical input into protocol design at a global level.
* Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials.
* Support CRA/ and Global teams in interaction with regional regulatory agencies.
* Provide assistance to CRAs and site for IEC/IRB Interactions.
* Support planning, implementation and follow-up of regulatory agency inspections and internal audits.



* M.D. Required


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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