Associate Medical Director/Medical Director(Cardiology)

3 weeks ago

Remote, Oregon, United States Thermo Fisher Scientific Full time

Job Description

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Essential Functions:

Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.


General Support:

  • Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG's corporate policies and SOPs/WPDs.
  • Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
  • Provides therapeutic training and protocol training on assigned studies, as
  • requested.
  • Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Clinical Trial Support:

  • Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
  • Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
  • Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
  • Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Marketed Products Support:

  • Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
  • Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.

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 speciality or sub-speciality associated with the applicants training (comparable to 2 years).
  • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry.
  • Direct experience in safety/Pharmacovigilance (comparable to 2 years).
  • Candidates with a background as a Cardiologist along with lipid disease experience are highly preferred.

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.

Knowledge, Skills and Abilities:

  • Therapeutic expertise across one or more medical specialty or sub-specialties
  • Strong decision-making, problem solving, organizational skills and analytical skills
  • Excellent oral and written communication skills
  • Working knowledge of relevant safety databases (e.g. Medra)
  • Flexibility to travel domestically and internationally
  • Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
  • Proficiency in basic computer applications
  • Fluent in spoken and written English
  • Excellent interpersonal, influencing and team building skills
  • Understanding guidelines (FDA, ICH, EMA and GCP)
  • Working knowledge of biostatistics, data management, and clinical operations procedures
  • Ability to act as a mentor/trainer to other staff within PV

  • Medical/Senior Medical Director

    2 months ago

    Remote, Oregon, United States Thermo Fisher Scientific Full time

    Job DescriptionOverview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development...

  • Medical/Senior Medical Director

    3 weeks ago

    Remote, Oregon, United States Thermo Fisher Scientific Full time

    Job DescriptionOverview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development...

  • Associate Director

    5 days ago

    Remote, Oregon, United States Precision Medicine Group Full time

    Hey there! We are looking for a motivated Associate Director, Clinical Work Orders to join our team at Precision for Medicine. In this role, you'll be supporting and developing the team to enhance contracting processes efficiently and drive the growth of Precision for Medicine. Excited about the opportunity to work in clinical research and take on a new...

  • Associate Design Director

    3 weeks ago

    Remote, Oregon, United States Hook Full time

    WHO WE AREHook is a Creative Production Agency. With a collaborative, maker-centric team, and an emphasis on craft-focused design, we develop creative campaigns, short-form content, and websites for well-known brands.Our mission is to integrate creative and production to help grow brands faster. But we believe what's most important are the people who work...

  • Associate Design Director

    1 month ago

    Remote, Oregon, United States Hook Full time

    WHO WE AREHook is a Creative Production Agency. With a collaborative, maker-centric team, and an emphasis on craft-focused design, we develop creative campaigns, short-form content, and websites for well-known brands.Our mission is to integrate creative and production to help grow brands faster. But we believe what's most important are the people who work...

  • Associate Scientific Director

    3 weeks ago

    Remote, Oregon, United States EPM Scientific Full time

    Associate Scientific DirectorCompany Summary:An independent, full service Med Comms agency is looking for an Associate Scientific Director to join their agency. This company is USA based but offers fully remote flexibility. If you're looking to move away from a corporate agency environment and into a company that values high quality work, great work-life...

  • Associate Scientific Director

    1 month ago

    Remote, Oregon, United States EPM Scientific Full time

    Associate Scientific DirectorCompany Summary:An independent, full service Med Comms agency is looking for an Associate Scientific Director to join their agency. This company is USA based but offers fully remote flexibility. If you're looking to move away from a corporate agency environment and into a company that values high quality work, great work-life...

  • Associate Director, Commercial Finance

    3 weeks ago

    Remote, Oregon, United States Greenhouse Agency Full time

    ***Must be located near Newport Beach, CA or Miami, FL (or willing to relocate). This is a hybrid position.***Who We Are:Green House is a Marketing Accelerator Business with deep expertise in Field Marketing & Sales, and an expanding portfolio of work tied to strategic market disruption. We are a team of over 200 cultivators committed to helping brands grow...

  • Associate Director, Commercial Finance

    2 months ago

    Remote, Oregon, United States Greenhouse Agency Full time

    ***Must be located near Newport Beach, CA or Miami, FL (or willing to relocate). This is a hybrid position.***Who We Are:Green House is a Marketing Accelerator Business with deep expertise in Field Marketing & Sales, and an expanding portfolio of work tied to strategic market disruption. We are a team of over 200 cultivators committed to helping brands grow...

  • Newscast Director

    2 months ago

    Remote, Oregon, United States Hearst Television Full time

    Newscast Director WMTW-TV, the ABC affiliate in Westbrook, Maine has an opening for an experienced and dynamic Newscast Director. The Newscast Director communicates and executes all technical aspects of live production, with all technical staff, including the Producer, Technical Director, Audio Operator, Studio, and Engineering. You will report to the...

  • Newscast Director

    1 month ago

    Remote, Oregon, United States Hearst Television Full time

    KSBW 8 (NBC) / Central Coast ABC / Estrella TV Costa Central, part of Hearst Television, has an opening for an experienced and dynamic Newscast Director. The Newscast Director is responsible for communicating and executing all technical aspects of live production, with all technical staff, including the Producer, Technical Director, Audio Operator, Studio,...

  • Associate Director

    4 weeks ago

    Remote, Oregon, United States CrossCountry Consulting Full time

    From the beginning, our goal was to establish an advisory firm that stands apart from the rest – one that is grounded in our Core Values and dedicated to creating a positive experience not just for our clients, but for our people too. We firmly believe in the strength of collaboration, enthusiasm, generosity, and perseverance as the driving forces behind...

  • Director of Physician Partnership

    3 weeks ago

    Remote, Oregon, United States NuvoAir Full time

    Where you'll see your impact:Reporting directly to the Chief Growth Officer, as the Director of Sales for Physician Partnerships by selling products and services with our Managed Services Organization (MSO). You will spearhead our sales strategies and initiatives across multiple states bringing superior technology, services and a platform to both cardiology...

  • Director of Physician Partnership

    4 weeks ago

    Remote, Oregon, United States NuvoAir Full time

    Where you'll see your impact:Reporting directly to the Chief Growth Officer, as the Director of Sales for Physician Partnerships by selling products and services with our Managed Services Organization (MSO). You will spearhead our sales strategies and initiatives across multiple states bringing superior technology, services and a platform to both cardiology...

  • Technical Director, Sports

    3 weeks ago

    Remote, Oregon, United States Warner Bros. Discovery Full time

    Every great story has a new beginning, and yours starts here.Welcome to Warner Bros. Discovery... the stuff dreams are made of.Who We Are... When we say, "the stuff dreams are made of," we're not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD's vast portfolio of iconic content and beloved...

  • Associate Director of Estimation

    5 days ago

    Remote, Oregon, United States Qcells Full time

    Hanwha Q CELLS USA Corp ("HQC US") develops, invests, and delivers solar photovoltaic (PV) and battery energy storage systems (BESS) projects through Engineering, Procurement, Construction (EPC) services in North America.The company brings a decade of global leadership in solar PV to deliver utility-scale power generation plants customized for local and...

  • Associate Director of Estimation

    3 weeks ago

    Remote, Oregon, United States Qcells Full time

    Hanwha Q CELLS USA Corp ("HQC US") develops, invests, and delivers solar photovoltaic (PV) and battery energy storage systems (BESS) projects through Engineering, Procurement, Construction (EPC) services in North America.The company brings a decade of global leadership in solar PV to deliver utility-scale power generation plants customized for local and...

  • Associate Director of Estimation

    3 weeks ago

    Remote, Oregon, United States Qcells Full time

    Hanwha Q CELLS USA Corp ("HQC US") develops, invests, and delivers solar photovoltaic (PV) and battery energy storage systems (BESS) projects through Engineering, Procurement, Construction (EPC) services in North America.The company brings a decade of global leadership in solar PV to deliver utility-scale power generation plants customized for local and...

  • Sales Director

    3 weeks ago

    Remote, Oregon, United States Simpli Full time

    WHO WE ARE: is the leading advertising success platform, providing programmatic advertising solutions and workflow software to over 2,000 media teams, agencies, and brands. empowers advertisers to maximize relevance, in what they do, in the connections made, and in the results delivered across CTV, mobile, display, and other media types. Our platform...

  • Sales Director

    4 weeks ago

    Remote, Oregon, United States Simpli Full time

    WHO WE ARE: is the leading advertising success platform, providing programmatic advertising solutions and workflow software to over 2,000 media teams, agencies, and brands. empowers advertisers to maximize relevance, in what they do, in the connections made, and in the results delivered across CTV, mobile, display, and other media types. Our platform...