Clinical research [h1.location_city]

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

Major tasks and responsibilities include :

• 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.

We seek candidates with the following qualifications :

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.