Medical Director - Clinical Development

203125
  • Remote/Hybrid
  • Permanent
Medical Director - Endocrinology
Position Overview
 
We are partnered with a small but expanding biotech who are seeking an experienced Medical Director to play a pivotal role in our clinical development efforts focused on endocrinology - obesity. The selected candidate will actively engage in the design, safety monitoring, and data analysis of our late-phase clinical trials. This role is integral to our clinical development team and offers a unique opportunity for impact and leadership. 
 
Key Responsibilities
  • Contribute to the development and execution of the Clinical Development Plan.
  • Apply medical expertise and practical clinical experience to enhance the relevance and rigor of our development program.
  • Provide guidance and leadership to study teams.
  • Oversee the design of clinical trials, offering ongoing support for site operations and subject retention.
  • Serve as a vigilant Medical Monitor for clinical trials, ensuring the integrity of studies and monitoring safety and efficacy data.
  • Facilitate the creation of essential trial-related documents, including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, and standard operating procedures, in collaboration with cross-functional teams.
  • Maintain the integrity of studies and monitor the collection of safety and efficacy data.
  • Analyse, assess, interpret, and report clinical data effectively.
  • Proactively address and resolve complex challenges in drug development.
  • Contribute insights to regulatory strategy.
  • Assist in drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions.
  • Stay up-to-date with the latest scientific advancements, medical knowledge, good clinical practices, and regulatory guidelines.
  • Collaborate with cross-functional colleagues (e.g., clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development.
  • Participate in, and when required, represent the clinical development department in corporate strategic and organizational initiatives.
  • Foster relationships with investigative sites, clinical consultants, and key opinion leaders to advocate for the company's interests.
  • Contribute as needed to portfolio management and commercial activities.
  • Execute assigned tasks meticulously, accurately, and within designated timelines.
  • Uphold high ethical standards in all endeavours.
Qualifications
  • Medical Doctor (M.D.) degree. Board Certification or PhD in Endocrinology or related field preferred.
  • A minimum of 5 years of industry experience (consideration given to relevant post-graduate experience in clinical and/or academic settings on a case-by-case basis). Candidates with less experience may be considered for an Associate Medical Director role.
  • A minimum of 3 years of experience in clinical trial design and execution.
  • Demonstrated track record of scientific and clinical inquiry.
  • Exceptional communication skills, both written and verbal.
  • Quick learner with the ability to follow complex instructions under pressure.
  • Proficiency in multitasking while maintaining organizational precision and attention to detail.
  • Effective leadership capabilities, leading by example.
  • Strong work ethic, reliability, and collaborative team spirit.
  • Proactive approach to problem-solving and sound judgment in handling complex, confidential, and regulated information.

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Oliver Gache Consultant - EU

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