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Head of Research
4 months ago
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.
- 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.
