The Challenge
A rapidly growing Montreal-based biotechnology company developing a breakthrough oncology therapeutic faced a critical leadership gap as they approached the final stages of their clinical development program. The organization urgently needed a Chief Medical Officer who possessed the rare combination of expertise in both Health Canada and U.S. Food and Drug Administration (FDA) regulatory pathways. The challenge was multifaceted: the ideal candidate required deep scientific credibility to lead interactions with regulatory agencies across two countries; proven experience guiding late-stage clinical trials through to approval; and the communication skills to serve as a credible spokesperson to institutional investors during an anticipated Series C funding round. The talent pool was exceptionally constrained, as few CMOs had successfully navigated parallel regulatory submissions in both jurisdictions, and the company’s timeline was aggressive given their upcoming pre-NDA meeting with the FDA.
The Solution
Lock Search Group implemented a targeted, bi-national search strategy leveraging our Montreal and Boston office expertise in the life sciences corridor. The search began with comprehensive stakeholder alignment meetings with the CEO, Board of Directors, and lead investors to precisely define both the technical qualifications and leadership qualities required. Our team conducted extensive market mapping across Canadian biotech firms with US operations, American pharmaceutical companies with Canadian subsidiaries, and contract research organizations specializing in cross-border submissions. We specifically targeted CMOs and VP-level medical affairs professionals who had shepherded products through both regulatory systems within the past five years. Recognizing that the ideal candidate needed to be both a scientific leader and an effective communicator with investors, our assessment process included structured interviews focused on regulatory strategy development, investor relations experience, and crisis management capabilities. We also engaged our proprietary network of life sciences executives in the Montreal-Toronto-Boston triangle to identify passive candidates who might not be actively seeking new opportunities.
The Outcome
The comprehensive search process identified 38 qualified candidates across North America who met the initial criteria. Through rigorous screening involving technical assessments, behavioral interviews, and reference verification, we presented a shortlist of four exceptional candidates to the client. The successful placement was a former Vice President of Clinical Development from a mid-sized US pharmaceutical company who had previously led Health Canada submissions while working for a Canadian biotech earlier in her career. This candidate brought not only the required dual-regulatory expertise but also established relationships with key FDA reviewers in the oncology division. Within her first six months, she successfully guided the company through their pre-NDA meeting, secured breakthrough therapy designation, and played a pivotal role in closing a $85 million Series C round by effectively communicating the regulatory strategy to investors. The placement demonstrated Lock Search Group’s ability to leverage our cross-border presence to source uniquely qualified leadership talent for complex life sciences mandates.