Clinical Consultant jobs

Engagement overview

A confidential development-stage pharmaceutical company is seeking an experienced consultant to guide the evaluation and advancement of its peptide therapeutics program. The consultant will support the assessment of candidate formulations through analytical characterization and, if supported by the results, comparative pharmacokinetic studies.

The mandate is to help select a development candidate and define a rigorous path toward preclinical development and an FDA pre-IND discussion. The engagement may be structured on a consulting basis, with scope and duration tailored to the program’s requirements.

Scope of work

The consultant will:

• Advise on the drug-development strategy, from formulation assessment through preclinical development and clinical planning.
• Review the proposed study program and recommend fit-for-purpose study designs, endpoints, controls, analytical methods and decision criteria.
• Provide pharmaceutical development oversight for the comparative evaluation of candidate peptide formulations.
• Assess analytical characterization plans covering identity, purity, physicochemical properties, solubility, stability and degradation, including under physiologically relevant conditions.
• Review study protocols, vendor capabilities, data quality and results; identify gaps and recommend follow-up work as needed.
• Establish candidate-selection criteria and assess whether observed differences are meaningful, reproducible and relevant to further development.
• Guide the design and interpretation of comparative pharmacokinetic studies, including assessment of systemic exposure, Cmax, AUC, half-life and other relevant parameters.
• Recommend the next development steps for the selected candidate, including formulation optimization, nonclinical pharmacology, toxicology, safety assessment and manufacturing development.
• Develop a staged development plan with key milestones, dependencies, timelines and budget considerations.
• Advise on preparation for an FDA pre-IND meeting, including briefing materials, proposed questions and the nonclinical and chemistry, manufacturing and controls (CMC) information needed to support regulatory feedback.
• Coordinate, as appropriate, with analytical laboratories, contract research organizations, academic investigators, regulatory consultants and other development partners.
• Present findings and recommendations in clear written reports and communicate them effectively to scientific, regulatory and executive audiences.

Required qualifications

• Ph.D., Pharm.D., M.D. or other advanced degree in pharmacology, pharmaceutical sciences, medicinal chemistry, toxicology, biomedical sciences or a related discipline. Candidates with a relevant bachelor’s or master’s degree and substantial pharmaceutical drug-development experience will also be considered.
• Substantial experience in pharmaceutical or biotech drug development, with expertise spanning preclinical development and a strong understanding of clinical development.
• Demonstrated experience advancing drug candidates through formulation assessment and preclinical development toward IND-enabling studies.
• Strong knowledge of analytical characterization and formulation development, including HPLC and/or LC-MS, stability assessment and interpretation of degradation data.
• Experience designing, overseeing or interpreting pharmacokinetic studies and working with CROs or academic research teams.
• Working knowledge of nonclinical safety and toxicology planning, CMC requirements and FDA regulatory interactions.
• Ability to critically assess evidence, distinguish exploratory findings from development-grade data and make clear, evidence-based recommendations.
• Strong project-management, scientific-writing and communication skills, including the ability to explain development decisions to executive audiences.

Preferred qualifications

• Experience with peptide therapeutics, peptide formulations or other formulation-sensitive compounds.
• Direct experience preparing for or participating in FDA pre-IND meetings.
• Familiarity with IND-enabling programs, GLP and non-GLP studies, and the transition from nonclinical development to clinical testing.
• Experience in clinical development strategy, including first-in-human planning and clinical pharmacology.
• Experience serving as an independent consultant or fractional development lead for a pharmaceutical or biotechnology company.

Engagement structure

The engagement may begin with a defined phase covering review of the proposed studies, recommendations on study design and external partners, and development of the candidate-selection strategy. The consultant may then support study oversight, interpretation of results and preparation of the selected candidate’s preclinical and regulatory development plan.

The role may be performed on a consulting basis, with the schedule and level of involvement agreed with the company. The consultant will work directly with company leadership and external scientific, regulatory and development partners. Company and program details will be shared with qualified candidates as appropriate.

Pay: $5,000.00-$12,000.00 per month

Benefits:

• Stock options

Work Location: Remote