Pharm-Olam

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Associate Medical Director (Open to US or Canada locations)*

at Pharm-Olam

Posted: 9/24/2019
Job Reference #: 2042
Keywords: operations

Job Description

  • Job LocationsUS | US | CA | US-TX-Houston | US-NC-Raleigh-Durham
    Job ID
    2019-2042
    Category
    Medical Affairs & Pharmacovigilance
  • Overview

    About Pharm-Olam, LLC:

    Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

    Summary:

    The Associate Medical Director works with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies conducted by Pharm-Olam are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP). To serve as the medical contact in study protocols to investigators and study sites team regarding protocol compliance issues and safety of the subjects enrolled. Advises and assures investigators, project teams, and clients on safety issues arising from medicinal products, devices and study designs undertaken by Pharm-Olam. Work with internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports in accordance with all applicable competent authority regulations and ICH E2 reporting standards. Ensure that protocols, investigator’s brochures, clinical trial reports written by Pharm-Olam are appropriately reviewed and approved in accordance with Pharm-Olam’s SOPs and good medical practices.

    This is a full-time, direct hire opportunity for an experienced Associate Medical Director. This position is being recruited for throughout the US & Canada and ideal TA experience should include: GI, infectious, rare diseases, etc.

    Responsibilities

    • Oversee the safety aspects of assigned clinical trials managed by Pharm-Olam including adverse events, safety reporting and laboratory testing. When appropriate, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen.
    • Prepares the Medical Monitoring and other relevant plans for studies conducted by Pharm-Olam prior to the start of the study
    • Serves as the medical monitor contact in study protocols
    • Assists with protocol interpretation and, as needed, contacts appropriate team members to ensure appropriateness of decisions arising from such interpretation
    • Assist primary Drug Safety Officer in reviewing IND safety narratives in accordance with FDA and ICH E2 reporting standards and oversees the processing of SAEs, SUSARs, etc. to clients and to regulatory agencies
    • Provide ongoing tutoring/medical education to DSOs (Drug Safety Officers), Regulatory, Clinical Operations personnel and other team members
    • Provides 24/7 monitoring coverage as required for the assigned protocols
    • Reviews and addresses all medical alerts setup for the safety of assigned projects
    • Reviews Investigational Brochures, protocols or other study-related documents produced by Pharm-Olam for accuracy, completeness and comprehension and to provide scientific and medical input as needed while providing direction to the medical writing personnel and activities of the company
    • Reviews clinical laboratory data on selected studies for safety tends or signals detection
    • Assists clinical data management with MedDRA and WHO coding
    • Conducts the medical reviews of safety listings and clinical trial data in assigned studies
    • Assists by reviewing or writing safety section of a clinical study report (CSR) and other safety reports including post marketing reports (e.g., PSUR)
    • Assists in the set up and conduct of Data Review Boards (DSMB, DMC, DMB or similar) as required by Pharm-Olam, with the supervision of more senior Medical Staff.
    • May advice and assist clients on product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Pharm-Olam. Liaise with country managers and department heads at Pharm-Olam as needed to meet this task
    • With the assistance of the country manager, provides medical interpretation on medical practices affecting the clinical trials managed by Pharm-Olam in the light of federal and local regulations. Where appropriate, maintains contact with various medical consultants
    • May provide therapeutic consultation in support of the scientific, medical and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.)
    • Attends and participates in Investigators’ meeting and other study-related meetings (KOM, ad-hoc) as requested
    • Attends and presents at major therapeutic conferences and drug development conferences
    • Supports the company’s growth through finding new clients and developing existing accounts in Business Development
    • Preparation and delivery of PVG, various medical/scientific and therapeutic area training
    • Other duties as assigned

    Working Relationship:

    • Typically reports to Senior Medical Director or other more senior Medical staff
    • Works with DSOs, Clinical Research Associates, Project Managers, ADPMs and other Departments (DM, Biostatistics, Regulatory, BD etc.) to support cooperative exchange of study and safety data

    Qualifications

    • MD or DO Degree required
    • Typically, at least three years medical monitoring experience and/or relevant clinical research experience.
    • Able to make medical decisions for the study independently and can act as primary medical monitor on assigned studies.
    • Able to review relevant medical documentation to give assistance to Business Development
    • May have Line management responsibilities to more junior Medical Affairs staff
    • Previous experience within a clinical and research environment
    • High level of Organizational and technology skills
    • High level of interpersonal and presentation skills.

    For Consideration

    Please apply online at www.pharm-olam.com/careers

    Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.