Head of Research

Our client is a biotechnology company. They have asked us to assist them in their search for a Head of Research.

• Provides strategic and operational guidance on corporate R&D playbook. Works with other members of the executive team to develop the company’s strategy and drive company R&D decisions.
• Guides discovery, and translational science activities to support clinical development.
• Leads strategy and builds a vision for team to execute on as it relates to drug discovery and preclinical development.
• Intimately involved in the due-diligence process for evaluating what programs to license in.
• Responsible for leading teams to timely deliverables, including data analyses and preparation of presentations and reports.
• Manages the discovery and translational program strategy, planning, and execution. Oversees programs designed to enable creative, timely, and compliant regulatory filings.
• Manages overall preclinical development operations, project resources, budget, and timelines for assigned programs.
• Defines disease target work streams that allow for high synergy and rapid drug program advancement.
• Compiles and summarizes nonclinical study information, including efficacy and toxicology studies, and ensures information is communicated appropriately and accurately to cross-functional program teams.
• Presents analyses and interpretations of nonclinical studies to regulatory agencies and other oversight bodies in meetings. Prepares nonclinical sections of regulatory filings, including briefing packages, IND applications / CTAs, annual reports, safety reviews, investigator brochures, and marketing applications.
• Provides insight and leadership to ensure that Bitterroot Bio achieves its major goals, appropriately sets priorities, and identifies compelling new opportunities.
• Collaborates with CMC team to ensure coordination of manufacturing activities and support for toxicology and pharmacology studies and to design in vivo studies in support of formulation transitions.
• Actively engages with leadership team business development opportunities that support the company’s R&D strategy.
• Plays a central role in enabling seamless transitions of product candidates from discovery to the clinic, in an environment characterized by rapid, integrated decision making.
• Initiates and manages relationships with third parties such as KOLs, SAB members, and academic partners to drive scientific innovation, develop a high-level target product profile and optimal R&D pathways, and help align preclinical development activities to the ultimate clinical endpoints.
• Represents the company as the senior R&D spokesperson to external constituencies.
• Ensures highest caliber of internal staff through hiring, mentorship, appropriate oversight and an effective network of outside partners, collaborators, and service organizations. Fosters an innovative and collaborative environment.
• Leads the evaluation, selection, and management of CROs, contractors, and vendors.
• Represents Bitterroot Bio externally at scientific meetings, regulatory agency meetings, and other stakeholders as appropriate.
• Interfaces and presents to the SAB and clinical advisory board as appropriate.
• Presents R&D strategy and timelines to the leadership and Board of Directors when appropriate.
• Will be responsible for expanding and building the discovery team through recruiting the most talented cardiovascular scientists and drug developers.

• PhD required. MD or equivalent preferred.
• Deep knowledge of the cardiovascular area required, including cardiovascular biology.
• Prior experience developing biologics is required. Experience with small molecules and / or cell therapy is strongly preferred.
• Endothelial cell culture experience is preferred.
• Requires significant experience in the pharmaceutical / biotech industry, with the demonstrated ability to build and lead an excellent preclinical development function, including outsourcing components and organizational design, as well as the recruitment, development, and retention of a first-rate team.
• Must have comprehensive experience advancing drugs from candidate selection through clinical PoC.
• Requires the ability to create and implement drug discovery and development strategy with up-to-date knowledge of relevant R&D pathways and the competitive landscape in the cardiovascular area.
• A track record of successfully developing drug candidates that advanced to clinical development and ideally to commercialization, introducing improvements to the R&D processes or operations, and devising novel solutions to problems.
• Must have experience generating and obtaining consensus on the criteria for the nomination of a drug candidate to preclinical development and clinical development.
• Must have detailed knowledge of the drug development process, Good Laboratory Practices, and regulatory requirements.
• Requires the ability to develop and lead collaborations and conduct science both internally and through collaborators and CROs.
• Must have…