Sr Medical Director/Medical Director - Clinical Development

Position Summary:

Reporting directly to the Chief Medical Officer (CMO), the Medical Director/Senior Medical Director of Clinical Development will be instrumental at all stages of clinical development programs, from drug discovery through global product registrations. The primary responsibilities include overseeing the planning and execution of clinical trials and exploring novel indications. The role requires providing medical expertise and clinical leadership to cross-functional project teams, developing clinical study outlines and protocols, and interpreting study results. The Medical Director will collaborate with various departments, including clinical operations, medical and scientific communications, commercial (marketing, sales, managed markets), regulatory, safety, product manufacturing and supply, as well as external partners, clinical investigators, and Key Opinion Leaders.

About Our Client:

Meet has partnered with an innovative biopharmaceutical company dedicated to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases), and cancers.

Essential Duties & Responsibilities:

• Strategic Planning: Develop strategic plans for clinical indications of product development candidates.
• Cross-functional Collaboration: Participate in teams to implement integrated clinical, scientific, and commercial strategies for our client's products.
• Clinical Leadership: Serve as the Clinical Lead and disease state expert, developing clinical development strategies.
• Trial Design and Execution: Translate clinical development strategies into trial outlines and protocols, provide ongoing medical monitoring, and ensure adherence to regulatory requirements.
• Regulatory Support: Prepare and review regulatory documents, IND annual reports, safety reports, and development plans.
• KOL Engagement: Work with Key Opinion Leaders to explore novel indications and develop study outlines.
• Data Analysis: Lead the collection, analysis, and interpretation of clinical data.
• Scientific Communication: Develop abstracts and manuscripts for scientific congresses and peer-reviewed journals.
• Team Collaboration: Provide scientific and clinical guidance to various internal departments and support business development opportunities.

Education, Experience, Skills, and Knowledge Required:

• Education: MD required, specialization and clinical experience in hematology or nephrology preferred.
• Experience: Minimum of 3 years in biotechnology/pharmaceutical clinical development.
• Skills: Excellent communication, problem-solving, and conflict resolution skills, with strong leadership abilities.
• Behavioral Competencies: Ability to work in a fast-paced environment, collaborate effectively with various stakeholders, and demonstrate strategic thinking and innovation.

Travel Requirements:

• This role requires 10 – 20% travel to medical conferences and other relevant events.