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Job Details

Senior Clinical Development Scientist

Company: SRG Woolf Group
Location: Massachusetts
Reference: JO000068377
Closing Date: 09 Mar 18
Type: Full Time
Salary ($): Negotiable
Benefits:

Job Summary:

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Requirements:

OVERVIEW

Provide scientific input to early and late stage clinical development programs. This role will work on cross-functional study teams for the design and execution of clinical trials, as well as data interpretation and communication.

This individual will report directly into a designated Medical Lead.

 

RESPONSIBILITIES

Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.

Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in communicating a clear overview of trial results.

Contribute to the organization, preparation, and execution of scientific meetings in collaboration with the project team.

Prepare literature review as needed.

Support preparation of scientific material for conference presentations or publications.

Provide scientific input to clinical research activities, including protocol development, study implementation, analysis and reporting of results.

Contribute to the authoring and revision of regulatory submissions

Facilitate communication of relevant scientific, clinical, or other findings to both internal and external stakeholders (e.g., generate scientific slide decks based on clinical trials).

Closely and productively interface with other functions including Clinical Operations, Pharmacovigilance, Data Management, Medical Affairs, Medical Writing, and Regulatory Affairs.

Perform other duties as requested.

 

QUALIFICATIONS AND EXPERIENCE

B.S./M.S./Ph.D. degree in a related life science discipline is preferred.

Minimum of 3 years’ experience working in biotech/pharmaceutical industry; preferably in clinical research group with a strong knowledge of drug development

Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills

Ability to work collaboratively in a fast-paced, team-based matrix environment, delivering on the review, analysis, and interpretation of study results

High level of organizational and project management skills

Flexible to accommodate changes in team and project needs

A comprehensive understanding of the drug development process in all phases of testing, contributing to the clinical strategy and creation of the clinical development plans while working as part of an integrated team.

Experience in providing support in preparation for scientific meetings (for example, advisory boards, consultant meetings and investigator meetings).

A thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills

Experience with interacting with medical monitors, development operations (clinical ops, RA/ QA) and clinical investigators.

Apply for this job: Senior Clinical Development Scientist

Contact Information:

Address:  Head Office
2841 Plaza Place
Suite 210
Raleigh
NC 27612
USA
Tel:  1-877-966-5347
Website:  Visit Our Web Site

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