Job Title: Clinical Development Consultant – Hepatology/NASH

Location: Remote (USA-based preferred)

Employment Type: Contract, Part-Time (20 hours per week)

About the Role:
BioTalent is excited to represent an innovative, growing biotech company focused on developing novel therapies targeting liver diseases, including NASH and other hepatology-related conditions.

We are seeking an experienced Clinical Development Consultant with extensive expertise in hepatology and NASH to support the company’s clinical development programs. This part-time contract role offers a unique opportunity to work with a dynamic, science-driven organization on the cutting edge of liver disease research.

Key Responsibilities:

• Provide expert guidance on the clinical development strategy for assets targeting liver diseases, with a particular focus on NASH.
• Review and refine clinical development plans, study protocols, investigator brochures, and related documents to ensure alignment with scientific, regulatory, and strategic objectives.
• Collaborate with cross-functional teams, including preclinical, regulatory, and medical affairs, to ensure the seamless progression of clinical programs.
• Act as a key advisor in interactions with regulatory bodies and provide medical and scientific expertise during submissions and meetings.
• Evaluate ongoing clinical trial data, offering insights and recommendations to optimize study designs and outcomes.
• Stay informed on the latest developments and trends in hepatology, NASH, and related fields to ensure the company’s clinical strategy remains innovative and competitive.
• Support KOL engagement and act as a subject matter expert during discussions with investigators, collaborators, and external stakeholders.

Candidate Profile:

Qualifications:

• Education: MD or equivalent medical degree, preferably with board certification in Hepatology or Gastroenterology.
• Experience:
• 10+ years of clinical development experience in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in NASH, liver fibrosis, and/or other hepatology-related conditions.
• Strong understanding of the regulatory landscape for liver disease drug development, including FDA and EMA requirements.
• Experience with clinical trials (Phase I-III) in hepatology or NASH is required.

Skills and Attributes:

• Proven ability to design and implement clinical strategies for hepatology-focused drug development.
• Strong analytical skills with the ability to interpret and evaluate clinical data critically.
• Excellent communication and presentation skills, with the ability to convey complex scientific concepts to diverse audiences.
• Collaborative and proactive mindset, with a commitment to driving innovation and excellence.
• Self-motivated and capable of working independently in a fast-paced, start-up environment.

What’s on Offer:

• Flexible, part-time contract role (20 hours per week) with a remote working arrangement.
• Competitive hourly rate, commensurate with experience.
• Opportunity to contribute to the development of cutting-edge therapies for liver disease.
• Chance to work with a passionate and forward-thinking team in a rapidly growing biotech.

How to Apply:
If you are an experienced clinical development professional with expertise in hepatology and NASH, we’d love to hear from you! Please submit your CV for consideration.