Clinical Development Scientist - fixed term contract

Pharmaceutical Research Associates, Inc; United Kingdom; Remote; GBP 60,000 - 90,000; Full time

Job summary

Join a leading clinical research organization as a Clinical Development Scientist on a 4-6 months contract. Responsible for leading clinical study teams, developing clinical strategies, and ensuring regulatory compliance. This home-based role requires extensive clinical experience and expertise in Endocrinology or related fields.

Qualifications

• More than 5 years of clinical experience preferably within industry.
• Experience as a medical monitor for clinical trials required.
• Advanced knowledge in Endocrinology or related fields.

Responsibilities

• Lead or support clinical studies and represent Clinical Development on teams.
• Prepare clinical development strategy and documentation for trials.
• Evaluate disease area information to inform clinical development.

Skills

Clinical Development

Medical Monitoring

Regulatory Knowledge

Data Interpretation

Collaboration Skills

Education

MD or PharmD with Clinical Development experience

Job description

Overview

As a Clinical Development Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

At this role you will lead a clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contribute to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for one or several projects, contributing to the development of clinical & regulatory strategy, and representing the clinical program at regulatory meetings and before external audiences.

This is role is for fixed term 4-6 months contract and is home based

Responsibilities

What you will be doing:

• Lead or support the clinical sub team and oversee the design and execution of one or two clinical studies.
• Represent Clinical Development on the Global Program Team and in presentations at management and review committees
• Lead a clinical subteam and prepare a clinical development strategy. May lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
• Determine appropriate advisory board experts and lead the team in preparation for meetings.
• Critically evaluate available information about diseases of interest to the disease area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
• Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert for clinical study team development Team / Subteam and the Medical Expert for clinical study team.
• Support business development activities, such as due diligence and research collaborations
• May serve as the Translational Science lead for one or more programs

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Qualifications

• MD or equivalent (PharmD with Clinical Development experience); Board Certification preferred
• >5 years of clinical experience preferably within industry
• Experience as a medical monitor for clinical trials required
• Regulatory experience preferred
• Publication in peer reviewed journals
• Advanced knowledge of the assigned therapy area (Endocrinology, bone metabolism or general internal medicine) and the capability to interpret, discuss, and represent trial- or program-level data are desired.
• Experience in medical responsibilities on a cross-functional team preferred