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Medical Director

Iovance Biotherapeutics, Inc.

United States

Remote

USD 100,000 - 387,000

Full time

Today
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Job summary

A leading biotechnology company is seeking a Medical Director to focus on the oversight and execution of clinical trials. The role involves direct management of clinical program development while collaborating with various departments to ensure the successful advancement of therapies. Candidates should possess a Board Certification as an MD and demonstrated experience in oncology clinical trials, along with excellent communication and interpersonal skills. This is a full-time position requiring approximately 15% to 25% travel, including visits to investigative sites and regulatory agencies.

Qualifications

  • Board Certified MD with minimum 2 years of oncology clinical trials experience.
  • Effective communication and excellent interpersonal skills.
  • Demonstrated independence, initiative and ability to work in a fast-paced environment.

Responsibilities

  • Oversees the direction and execution of clinical trials including protocol implementation.
  • Manages program development across multiple disciplines necessary for drug development.
  • Supports data analysis and clinical study report writing.

Skills

Effective oral and written communication skills
Interpersonal skills
Independence and initiative
Problem-solving and analysis

Education

Board Certified MD
Oncology clinical trials experience (minimum 2 years)

Job description

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The Associate Medical Director is primarily responsible for overseeing the direction, planning, execution, and interpretation of clinical trials and the data collection.

Essential Functions and Responsibilities

  • Directs protocol implementation including site identification and communication, attendance at investigators’ meetings, correspondence with sites including IRBs and interaction with operations teams.
  • Manages program development, including working cross-functionally with all of the disciplines necessary for successful drug/therapy development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, legal, biostatistics and data management, pharmacovigilance, and clinical operations.
  • Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies.
  • Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff.
  • Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts.
  • Interacts closely with Medical Affairs in support of ISTs and publications.
  • Interacts closely with the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies.
  • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Travel

  • Travel time is approximately 15% to 25% including visits to investigative sites, regulatory agencies, non-local company sites, and attendance at major oncology meetings

Required Education, Skills, and Knowledge

  • Board Certified MD with minimum 2 years of oncology clinical trials experience (may be within industry or academia)
  • Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
  • Demonstrated independence, initiative and the ability to work well in a fast-paced environment

Preferred Education, Skills, and Knowledge

  • Subspecialty training in oncology and/or hematopoietic transplantation preferred
  • Outstanding academic achievement and significant clinical trial experience preferred

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

  • Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
  • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
  • Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
  • This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
  • Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

#LI-remote

Seniority level
  • Seniority level
    Associate
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Other and Science
  • Industries
    Biotechnology Research and Pharmaceutical Manufacturing

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