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26 days old

Associate Director/Director in the Global Medical Evidence Generation team

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Associate Director/Director in the Global Medical Evidence Generation team in Gaithersburg, MD to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.


**Primary Responsibilities of the** Associate Director/Director in the Global Medical Evidence Generation team **includes:**


We work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our peoples exceptional skills with those of people from all over the globe. In the Global Medical Evidence Generation team, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. Major activities included in this role: critical appraisal and synthesis of relevant epidemiological literature; design, initiation, management, conduct, analysis, and reporting of epidemiological studies, including observational and interventional studies; and development of medical evidence plans to fill critical knowledge gaps, including support to specialized areas (e.g., biomarker development, disease modelling, & health economics).


As a Associate Director/ Director in the Global Medical Evidence Generation team, you will be working with internal and external customers to ensure appropriate communication of results to stakeholders, including providing epidemiological/outcomes research support for responses to questions posed by regulatory authorities. They perform research on secondary data (e.g. electronic healthcare databases) either internally or through collaboration with external research and academic groups. Additionally, they design and conduct primary data collection studies (e.g., non-interventional and interventional) through external service providers.


In some of this role you will be supporting our in house study delivery model to help studies are delivered delivered efficiently and on time within the Global Medical Affairs Oncology Business Unit.

Finally, they ensure that timeframes are negotiated appropriately for the completion of tasks, and that the tasks are carried out as agreed and results presented effectively.


The Associate Director/Director in the Global Medical Evidence Generation team is a high-level, and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and efficient global epidemiology study design and methodology. The role holder will lead the development of study design and methodology while ensuring scientific quality on balance with timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs.


Requirements


+ Experience in the pharmaceutical industry or in closely related academic epidemiological research

+ Experience using Real World Data to develop Real World Evidence Study design, methodology, and execution

+ Experience understanding complex medical evidence needs with an ability to translate that understanding in to a study design

+ Sustained productivity in epidemiological research as manifest by successful design, execution, and publication of original epidemiological research relevant to drug discovery and development (e.g., drug safety) or commercialization in peer-reviewed journal

+ Experience in utilizing secondary data and also conducting primary data collection studies

+ Emerging recognition by the external scientific communities as an expert in the application of epidemiology to areas relevant to drug development and commercialization

+ Sustained record of epidemiological productivity at a strategic as well as an operational level

+ Able to effectively engage and consult with recognized key external scientific experts


Desirable Requirements


+ Able to provide critical appraisal to study designs and published studies

+ Excellent knowledge in epidemiological methodology and ability to apply it within the pharmaceutical industry at an international level

+ Ability to apply advanced epidemiological theory and techniques throughout the product life cycle

+ Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management

+ Experience managing complex medical evidence programmes, including interventional studies such as pragmatic trials

+ Ability to work effectively with External Experts, Collaborative Groups and Contract Research Organisations

+ Ability to present advanced epidemiological topics at Professional and Scientific meetings

+ Ability to incorporate novel epidemiological techniques into projects

+ High degree of conceptual thinking skills

+ Excellent understanding of overall business strategy and its link to the various disease areas

+ Familiarity with relevant regional and international regulatory requirements

+ Ability to make complex judgments, develop innovative solutions, and apply comprehensive cross-functional and industry understanding to individual projects and programs

+ Ability to access external resources as necessary, including specialist expertise

+ Ability to effectively represent the Company to external stakeholders, including regulatory authorities and key scientific opinion leaders

+ Proactive and able to work independently

+ Proven team-working skills

+ Able to respond to changes in the internal and external environment by adjusting plans or developing new ways of working

+ Excellent communication skills and cultural sensitivity

+ Ability to influence through effective communication, respectful challenge, and persuasion rather than dictate the beliefs, opinions and behaviours of key customers and others at a senior level across the business (including Discovery, Development and Commercial functions).

+ Ability to effectively engage with a wide variety of technical and business experts

+ Strategic direction


**Education and Experience Requirement of the** Associate Director/Director in the Global Medical Evidence Generation team **includes** :


+ Ph.D. or equivalent in epidemiology or related health science field and a minimum of 5 years of experience in the health care environment.

+ Alternatively, an MSc or MPH with more than 10 years of experience in the health care environment

+ CROSS FUNCTIONAL TEAMS, US Experience is accepted but, GLOBAL EXPERIENCE would be highly desirable

+ 3+ Years of experience with study design of Real World Evidence Studies (ie Retrospective Studies, Chart Reviews, Synthetic Control Arm, and Systematic Literature Reviews etc.)

+ 3+ years of experience working with Real World Data (i.e. Disease Registries, Electronic Health Records, disease registries, large data bases such as FlatIron).

+ 3 YEARS and above PHARMA/VENDOR MANAGEMENT/DIRECTORSHIP would be ideal


**Additional Information:**


+ Contract assignment, duration 12 months.

+ Work schedule: full-time, first shift.


**Kelly Temporary Employee Perks:**


+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts


**Apply Now!**


This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:


Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3402940]


Thank you for your interest in the assignment.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-15 Expires: 2021-04-15

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Associate Director/Director in the Global Medical Evidence Generation team

Kelly Services
Gaithersburg, MD 20898

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