Associate Medical Director Job Listing at Kelly Services in Cambridge, MA (Job ID US3615708_BH10001116)

Description

Contract Clinical Trial Physician – Pediatrician Remote East Coast  

• Contract Associate Medical Director (Clinical Trial Physician)
• East coast based – Remote – work from home
• Up to 20% travel max if needed
• Six-month contract with possible extension depending on study needs
• Full time – 40 hours a week expectation
• W-2 hourly pay rate depending on experience: $110.00 - $117.00 an hour

Overview:
Provides clear medical leadership in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.

Essential Functions:

• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contributing to site selection, contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
• Real-time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead
• Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
• Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
• In case more than 1 physician is working on the protocol, a primus inter pares will be appointed and he/she will ensure that answers to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics

Education and Experience:

• MD or equivalent required.
• Active medical licensure preferred.

Candidates should have at least one of the following:

Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years)

Or Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry

Or direct experience in safety/Pharmacovigilance (comparable to 2 years)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Medical monitoring experience is required

Experience at a pharmaceutical, biotech, or CRO

Must have solid experience with PIPs (pediatric investigation plan)

Must be east-coast US

Able to travel up to max of 20%

Excellent English, both written and spoken is a must
Desired Skills and Experience:

• Medical Doctor:
• relevant specialty education preferred (e.g. neurology, hematology, dermatology, immunology, rheumatology, internal medicine, pediatrics)

Some experience in industry (sponsor, biotech, CRO) preferred

Proven interpersonal skills enabling you to lead a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately

Proactive problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization

Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties.

A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

 Apply on company website