Covance Senior Medical Director - Rheumatology / Inflammatory - US or EU based in Rome, Italy

Job Overview

Reporting to the Vice President and Global Therapeutic Area Head of Infectious Disease and General Medicine, the primary role of the incumbent will be to serve as a lead physician providing subject matter and drug development expertise. He/She will be expected to be a key contributor to the medical strategy and execution of clinical programs. Furthermore, the Sr. Medical Director will play a key role in people leadership/management, client relations, and business development representing Covance in proposals and industry meetings as needed.

This is a remote home-based role with up to 40% global travel.

Incumbent can be either US or EU based.

Company Focus

  • Contributes to the development of Company policies involving medical, safety and therapeutics

  • Participates in process improvement activities across Company

Client Relationship & Business Development Activities

  • Partnering with GCO to develop new and enhance existing client relationships where possible

  • Provides leadership and presents medical/scientific capabilities to clients as a participant of a proposal team

  • Leverage known and builds new relationships with investigators/sites to performs site/investigator feasibility and to support optimal recruiting and conduct of trials

  • Able to present or serve on panels to represent the company at conferences and scientific meetings.

Managerial

  • May provide mentoring to and be responsible for the oversight, career development and evaluation of Clinical Research Physicians, Associate Medical Directors and Medical Directors

  • Supports and participates in the recruitment process for department positions

  • Involved in assignment of projects and specific duties to direct reports

  • Responsible for administration and/or delegation of activities of his/her direct reports (for example PTO, timesheet and expense approval)

Leadership

  • Provides leadership to staff within the therapeutic area

  • Leads initiatives that impact and involves physicians within and across the TA

  • May contribute to vision and strategy/direction for therapeutic areaTherapeutic and Scientific Expertise

  • Develops training modules and materials, and provides training in disease states and protocol specific requirements across the Company

  • Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines

People Responsibilities

  • Serves as global lead project physician and can serve as a program level physician across multiple indications for a given company

  • Provides subject matter and drug development expertise to be a key contributor to the medical strategy and execution of the program for the client

  • Performs medical data review - Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed

  • Develops, reviews and revises protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications

  • Prepares materials for investigator meetings

  • Actively participates in investigator meetings

  • Provides medical/scientific expertise to project teams

  • Responsible for medical and safety monitoring on assigned projects

  • Interacts with inter-departmental and external consultants as appropriate

  • Participates in feasibility discussions relating to specific project proposals

  • Participates in project risk assessment activities

  • Assists when needed with data safety monitoring board activities

  • Provides clinical and medical expertise to other Covance departments

  • Contributes to the scientific strategic leadership for a given therapeutic area

Education/Qualifications

  • MD degree

  • Specialization in Rheumatology, Immunology, Inflammatory, or Autoimmune disease is highly desired

  • Relevant sub specialty fellowship training

  • History of Board Certification

Experience

  • Minimum of 5 years clinical research experience

  • Experience in and specialization in Rheumatology, Immunology, Inflammatory, or Autoimmune disease is highly desired

  • Substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industrysupporting Phase I - IV clinical trials

Job Number 2018-20731

Job Category Clinical Operations

Position Type Full-Time

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