Drug Manufacturing & Research jobs

Drug Development Consultant | BPC-157 Program | Remote

Engagement Overview

A development stage pharmaceutical company advancing a BPC-157 therapeutics program is seeking an experienced scientist and drug development consultant who shares our conviction in BPC-157’s therapeutic potential and brings the scientific rigor to evaluate it objectively.

The consultant will lead multiple development workstreams, with an immediate focus on selecting a development candidate through the comparative evaluation of oral BPC-157 formulations. This work will include analytical characterization, comparative pharmacokinetic studies and development of a clear path toward preclinical development and an FDA pre-IND discussion.

This is a remote consulting engagement with an anticipated commitment of approximately 10 to 15 hours per week. Scope and duration will be tailored to the program’s needs.

Scope of Work

• Lead the BPC-157 development strategy across concurrent workstreams, from formulation assessment through preclinical development and clinical planning.
• Direct candidate selection by reviewing study designs, endpoints, controls and analytical methods; establishing clear selection criteria; and assessing whether observed differences are meaningful, reproducible and relevant to further development.
• Oversee the analytical characterization and evaluation of candidate formulations, including identity, purity, stability, solubility, permeability and degradation under physiologically relevant conditions.
• Guide the design and interpretation of comparative pharmacokinetic studies, including systemic exposure, Cmax, AUC, half-life and appropriate bioanalytical methods.
• Manage external development partners, including analytical laboratories, contract research organizations (CROs) and academic investigators. Review protocols, capabilities, data quality and results, and recommend follow-up work where needed.
• Recommend next steps for the selected candidate, including formulation optimization, nonclinical pharmacology, toxicology, safety assessment and manufacturing development.
• Develop a staged development plan with clear milestones, decision points, dependencies, timelines and budgets.
• Advise on FDA pre-IND preparation, including briefing materials, proposed questions and supporting nonclinical and chemistry, manufacturing and controls (CMC) information.
• Present findings and recommendations clearly to scientific, regulatory and executive audiences.

Required Qualifications

• An advanced degree, such as a Ph.D., Pharm.D. or M.D., 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 industry experience will also be considered.
• A strong, literature informed conviction in BPC-157’s therapeutic potential, paired with the ability to critically assess evidence, uncertainties and development risks.
• A demonstrated record of managing multiple drug development programs or workstreams concurrently.
• Substantial experience advancing drug candidates from formulation assessment through preclinical development toward IND-enabling studies, together with a working understanding of clinical development.
• Strong expertise in 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 managing CROs or academic research teams.
• Working knowledge of nonclinical safety and toxicology planning, CMC requirements and FDA regulatory interactions.
• Sound scientific judgment, including the ability to distinguish exploratory findings from evidence suitable for development decisions and regulatory use.
• Strong project management, scientific writing and communication skills, including the ability to translate complex findings into clear, actionable recommendations.

Preferred Qualifications

• Direct experience with BPC-157 or other peptide therapeutics.
• Experience addressing oral peptide delivery challenges, including formulation stability, permeability enhancement and oral delivery strategies.
• 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 with first in human study planning and clinical pharmacology.
• Previous experience as an independent consultant or fractional drug development lead.

Engagement Structure

The engagement may begin with a defined initial phase covering review of proposed studies, study design recommendations, assessment of external partners and development of the candidate selection strategy.

Subject to program progress and results, the engagement may extend to study oversight, data interpretation and preparation of the selected candidate’s preclinical and regulatory development plan.

The consultant will work directly with company leadership and external scientific, regulatory and development partners. Additional company and program details will be shared with qualified candidates as appropriate.

Time Commitment: Approximately 10 to 15 hours per week, with scheduling agreed based on program requirements.

Compensation: CAD $5,000 to $12,000 per month, depending on experience, scope and level of involvement.

Location: Remote.

Engagement Type: Independent consulting.

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

Work Location: Remote