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:

• 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 experience conducting preclinical studies leading to successful IND submissions and a proven track record or achieving product success and approval.
• Experience building and managing collaborations with scientists, CROs, consultants, pharmaceutical partners, and other outside organizations is required.
• Must be a professional with the highest standard of integrity and a patient-centric mindset.
• Must be a strong, natural leader with the ability to manage people and provide mentoring at the highest levels including those outside of your own scientific expertise.
• Must have strong written and oral communication skills and the ability to present complex data to a wide range of audiences.
• Requires experience leading high-performing teams, including recruiting, developing, motivating, and empowering team members. Experience working cross-functionally and delegating effectively.
• Provides clear direction and vision to team members to foster a collaborative and high-performance work environment.
• Drives innovation and continuous improvement within the team and organization. Maintains a proactive approach to personal and professional development of team members.

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.