Operating Partner, Pharma Services and Clinical Development

Responsibilities

• Biostatistics, statistical programming, and biometrics
• Regulatory affairs, regulatory strategy, and submissions consulting
• Medical and scientific writing
• Pharmacometrics, modeling and simulation, and quantitative pharmacology

Clinical data management and clinical data platforms

• Bioanalytical, central lab, and specialty testing services supporting clinical programs
• Provide market intelligence on bolt on targets, competitive landscape, and valuation context within your subsector
• Facilitate introductions to founders, scientific principals, and senior executives in your existing network
• Review confidential information memoranda and management presentations for sector specific operating fit and risk
• Assess the durability of a target's regulatory track record, therapeutic depth, and technical staffing as part of diligence
• Distinguish between backlog that converts and backlog that evaporates, and pressure test a target's revenue quality accordingly
• Participate in PE sponsor and strategic acquirer pitches when your subsector and operating background are relevant
• Provide operational due diligence input on target companies
• Advise the Fireclay team on positioning and messaging for sponsor outreach and sourcing campaigns

The Role

Operating Partners are senior operators and scientific leaders who work alongside the Fireclay deal team on the transactions where their domain expertise decides the outcome. This is a per engagement consulting role, not full-time employment. Engagements typically run three to twelve months on a deal specific basis. We are selective about who we bring in, and we are currently engaging operators across the following subsectors:

Drug development advisory and translational strategy

Pharmacovigilance, safety, and risk management

What We Are Looking For

Division President, General Manager, VP or SVP of Operations, Chief Scientific Officer, Chief Statistical Officer, Head of Regulatory Affairs, COO, or CEO at a CRO, regulatory consultancy, biometrics provider, or specialty pharma services business, or Head of Corporate Development at a sector consolidator

Fifteen years or more in the sector across multiple service lines, therapeutic areas, or geographies

Working command of the regulatory environment your subsector operates in, including FDA and EMA submission pathways, ICH and GxP expectations, and the inspection history that follows a business through a transaction

Direct experience with the operating dynamics that drive value in this sector, including utilization, backlog conversion, book to bill, scope expansion, multi-site and cross border integration, and retention of scientific and technical staff

Familiarity with the ownership structures common to independent firms in this market, including founder and scientist owned businesses, carve outs from larger sponsors, and how each affects a transaction

Existing network of relationships with founders, scientific principals, senior executives, and PE professionals across your subsector

Comfort representing Fireclay professionally to PE sponsors, strategic acquirers, and target company management

Discretion when handling nonpublic information and competitive intelligence

Willingness to work on a flexible per engagement basis without fixed hours or commitments

Compensation

1099 independent contractor structure

• Per deal success fees on closed engagements where you contribute meaningfully
• Optional retainer for active sourcing assignments
• Equity participation available on select strategic engagements
• No fixed hours or minimum time commitment

Location

Remote. US or Canada based. Travel is minimal and deal specific.

How to Apply

Resume or LinkedIn URL

Fireclay Partners is a veteran owned and operated firm and is an equal opportunity employer. We are committed to building a team that reflects a diverse range of backgrounds, experiences, and perspectives.