Senior Medical Director - Endocrinology
We are seeking an experienced Senior Medical Director to play a pivotal role in our clinical development efforts focused on endocrinology and rare diseases. 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. The Medical Director position is located in the UK, preferably in London, and reports directly to the Vice President of Clinical Development.
- 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.
- Lead teams of medical monitors.
- 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.
- Travel up to 20% domestically and internationally to engage in scientific conferences and meetings.
- MD, Board Certified in ideally endocrinology or rare genetic disease background. Can look at cardiology for someone very strong
- Need to be a strong clinical development leader
- Previous management exp. Ideally 3 or more direct reports
- Needs to have led a program on a larger scale
- Looking at 7/8 years + exp
- Regulatory experience
- Needs to be able to hold their own in meetings with c suite etc
- 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.