12 days old

Clinical Development Scientist III

Kelly Services
Lexington, MA 02421
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Clinical Development Scientist** at a prestigious Fortune 500 company working in **Lexington, MA.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Clinical Development Scientist**

**Pay: $65 - $80 depending on experience**

**Position Summary** :

Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of GCDL

Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles

Provides clinical scientist input into all regulatory questions, runs ad hoc searches

Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation

Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,

Support GCDL to provide scientific leadership in execution of clinical trials

Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables

Serve as a resource to address medical questions or clarify issues arising during conduct of the study

Assists Business Development with assessments and intelligence on potential new products and

assists with due diligence activities as required.

Assist in the review, analysis and reporting of clinical trial data

Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.

Collaborates with Global Development Clinical Lead, and Global Product Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and


Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.

Supports the GCDL when participating in clinical/medical advisory panels, steering committees and investigator meetings.

Assist the GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.

Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all


Supports the GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs.

Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.

Participates in drug safety surveillance for Development projects.

Act on behalf of GCDL leading the interpretation of trial data and development and review of clinical study documents, reports etc,

Significant experience (7-10 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.

Demonstrated ability to collaborate in a matrixed environment

Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or

Experience in designing and conducting Phase 11-111 clinical trials; and/or

Significant late-stage development research.

Expertise in infectious disease and/or Transplant Medicine preferred

Experience in rare diseases highly desired

Demonstrated understanding of drug development and pharmaceutical marketing within Therapeutic area.

Working knowledge of regulations relating to drug development and promotional activities

Demonstrated ability to communicate and plan effectively with other departments and to respond to inquiries or complaints from customers.

Able to work independently, prioritize and meet project timelines

Demonstrated ability to effectively present information to employees at all levels of the organization

Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results.

Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization.

Ability to capitalize on business opportunities by developing well thought out strategies and initiatives.

Complexity and Problem Solving

Good analytical skills and ability to review emerging data and clinical outputs are required daily in

order to make appropriate decisions and institute measures to ensure quality results and safety. It is expected that incumbent will take initiative and work independently, however, ongoing communication with GCDL is a vital part of problem-solving and decision-making.

Incumbent is to escalate any issues requiring GCDL oversight and input.

**The top 3 requirements** :

1. Advanced degree i.e. Pharm. D/M.D./Ph. D required

2. Prior experience in clinical development minimum 2 years

3. Good analytical skills and the ability to review emerging data from clinical studies.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-11-01 Expires: 2019-12-02

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Clinical Development Scientist III

Kelly Services
Lexington, MA 02421

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