Company Overview

This is a pharmaceutical company that focuses on orphan and autoimmune diseases.

Position Title: Medical Director, Clinical (#2108-5627)

The Medical Director plays a key role within clinical development for product programs from drug discovery through product registrations.

S/he oversees ongoing and planned product trials and the exploration of novel indications, and provides clinical leadership to cross-functional project teams on  clinical development strategies, clinical study outlines, and data interpretation of study results.

Essential Duties and Responsibilities

  • Develops and executes clinical program strategies for multiple indications, including trial design and medical oversight to meet overall program goals. 
  • Responsible for original writing, editing, and review of medical and scientific elements of clinical research documents to ensure accuracy, consistency with the standard of care, logistical ease, and internal consistency, as assigned. 
  • Provide medical input and or author sections of regulatory documents such as IND/NDA  submissions, MAAs, product labeling, and promotional materials. 
  • Medical leadership on trial and program teams as assigned. May be assigned to provide representation to the Product Leadership team, leadership team, and BOD interactions on the project. 
  • Medical leadership in presenting the product externally to academic, regulatory, prescriber, government, and payer communities. 
  • Provide medical support, expertise, and perspective in corporate partner interactions on assigned projects. 
  • Accountable, together with Safety Officer, for detecting and communicating adverse safety signals to internal responsible parties. 
  • Identify and evaluate external disease, treatment, and epidemiologic data sources as required. 
  • Attend appropriate scientific meetings and stays up to date with the relevant scientific literature to maintain expertise. 
  • Co-author external presentations, posters, and manuscripts in collaboration with principal investigators on the product. 
  • Contribute to and advise on the development of clinical research documents including protocols, informed consent forms, training materials, study manuals, guidelines, etc. 
  • Educate investigator and site staff on the medical and scientific aspects of protocols, as assigned. 
  • Responsible for medical monitoring, including appropriate subject inclusion into protocols, regular review of clinical and laboratory findings in ongoing clinical trials, and responding to medical queries from investigators and sites. 
  • Advise Clinical Managers on the adequacy of clinical and laboratory monitoring schedules in study protocols to achieve trial objectives. 
  • Oversee ethical conduct of assigned protocols. 
  • Support clinical operations in detection and communication of adverse trends in any aspect of study conduct, as appropriate to the issue and audience. 
  • Provide medical and safety input and or authors sections of the Clinical Study.

Qualifications (Education & Experience)

  • MD from a US accredited institution preferred with postgraduate training. US board-certified or board-eligible and at least 2-5 years clinical experience with direct patient care responsibilities. 
  • Demonstrated drug development experience within the biotech/pharmaceutical industry, including medical monitoring, 2-5 years required. 
  • Experience with anticipating and solving the practical issues encountered in the execution of clinical trials. 
  • Strong quantitative skills, including solid familiarity with statistical and epidemiological concepts (record of publication in the field is desirable). 
  • Understanding of the clinical-regulatory-commercial development process and its intricacies. 
  • Ability to manage multiple projects and maintain timelines and work in cross-functional teams. 
  • Deep familiarity with ICH and GCP guidelines. 
  • Excellent written and oral communication, interpersonal, and organizational skills.

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.

Learn more at www.trinetpharma.com.

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