FirstString Research is a clinical stage biotechnology company founded on a vision to deliver clinically relevant and effective solutions for inflammation-based medical conditions through an understanding of the molecular and cellular contexts that define the underlying pathology. Our focus is on diseases with unmet medical needs associated with dysregulation of inflammatory processes and an impaired injury response.
FirstString is a high growth, fast paced organization that offers competitive salary and benefits including 401k to employees at all levels. We are currently seeking highly motivated, self-driven individuals to join our team. The ability to be productive and successful in an intense work environment is critical.
Senior Director/Director of Clinical Operations
The Senior Director/Director of Clinical Operations will be a key leader in strategic planning, oversight, and operational management of FirstString Research’s clinical trial portfolio. The Senior Director/Director of Clinical Operations will work across multiple functions to ensure operational trial deliverables are completed according to established timelines, budget, operational procedures, quality standards, and in compliance with applicable ICH/GCP regulations. This includes developing and overseeing clinical operational plans aligned with corporate strategy and R&D objectives; close communication and collaboration with contract research organizations (CROs), clinical sites, and/or vendors; study budget management; trial timeline management; development of clinical trial designs with insight from key opinion leaders; and quality assurance of clinical data. The Senior Director/Director of Clinical Operations will provide oversight and strategic guidance to FirstString’s clinical operations team and will work closely and collaboratively with other senior and functional leaders to ensure harmonized and integrated development strategies to drive portfolio prioritization.
Ideal candidates have a background in the biotechnology/pharmaceutical industry, with strong leadership skills and a proactive drive to develop and improve consistent project management excellence to achieve clinical trial deliverables.
Key Essential Functions:
- Lead and oversee CROs and external vendors to conduct clinical trials at the highest quality and within established timelines and budgets
- Organize and oversee activities of FirstString’s clinical operations staff and vendors/service providers involved in the conduct of assigned clinical trials
- Communicate project objectives and deliverables with clinical sites and CROs
- Maintain regular contact with CROs and external vendors to assess performance and provide guidance as needed
- Proactively identify hurdles or challenges in study conduct/management and provide efficient, innovative solutions and mitigation strategies in collaboration with Executive/Senior management
- Lead the development and contribute to the preparation of relevant study documentation including clinical protocols, operational study plans, statistical analysis plan, clinical study reports, etc. Review and refine clinical operational plans as needed.
- Develop and manage study timelines (including recruitment)
- Oversee FDA regulatory submissions
- Identify talent and resource gaps – responsible for performance management of clinical operations staff
- Bachelor’s degree or advanced degree in health sciences or related discipline. Advanced degree is desirable.
- Minimum of 10 years relevant clinical research experience in biotechnology/ pharmaceutical industry or CRO. Background in biotechnology or pharmaceutical industry preferred, but not required.
- Minimum of 5 years upper level management and relevant supervisory experience
- Strong experience in vendor management, leading CROs/contracted resources, site monitoring, clinical quality compliance, and managing clinical trial budgets
- Demonstrated experience in clinical operations development and strategic planning, as well as experience in early to late-stage clinical trials
- In-depth knowledge of the drug development process (IND to NDA), including FDA regulations and expectations
- Excellent working knowledge of clinical SOPs, GCP, and ICH guidelines
- Demonstrated ability to successfully manage multiple projects with equal priority
- Well-honed leadership and organizational skills, capable of leading by example, thrive on increasing levels of responsibility, proactively and confidently moves the business forward, sense of urgency to meet pressing deadlines in a fast-paced environment, uses insightful and critical thinking to optimize operational management of clinical trials
- Dedicated team player, displays positive attitude, directly contributes to team efforts, and builds strong relationships with a wide range of stakeholders, both internally and externally, at all levels (e.g. Executive/Senior management, KOLs, CRO team members, cross-functional team members, etc.)
- Detail and quality oriented with demonstrated track record of successfully meeting project deliverables within established deadlines, budget, and allocated resources
Please send a resume and cover letter to email@example.com
The Translational Scientist will be responsible for conducting a full range of activities required to conceptualize, prepare, submit, and manage grant proposals and regulatory documents to foundation, government and corporate sources. Responsibilities include exploring and sourcing new funding opportunities, producing high quality scientific documents for funding applications and publication, including writing and editing grant proposals, scientific manuscripts for peer review, white papers, protocols, commercialization plans, reports, and regulatory documents; as well as overseeing successfully funded projects.
- Proactively identify government, industry, and nonprofit funding opportunities.
- Identify fit between company’s technical capabilities and priorities and granting agencies’ research needs.
- Perform literature/product searches on new ideas to understand and assess novel advancements as they relate to FirstString’s product roadmap.
- Work closely with staff in developing and transforming ideas into grant proposals.
- Establish and maintain collaborative relationships with scientists and physicians in academic and private institutions.
- Oversee and report on progress of successfully funded projects.
- Maintain comprehensive and up to date knowledge of platform technological advances and particular market areas involved in identifying and soliciting grants.
- Manage deadlines and deliverables and keep all involved parties on schedule.
- Draft high quality written grant applications.
- Assist with assembling scientific documents as necessary (e.g., institutional grants, annual/interim reports, progress reports for grants admin., etc.).
- All other duties as required.
- Ph.D. in Biology, biochemistry, other life science, or relevant background; postdoctoral fellows; Assistant/Associate Professor level.
- Exceptional verbal and written English language communications skills.
- Proven experience in writing grants, including NIH R01 proposals, SBIRs, STTRs and/or experience with IND applications and clinical protocols preferred.
- Project management experience and the ability to work well with a project team.
- Ability to problem-solve, think objectively, act proactively, and work independently.
- Ability to handle changing priorities and multiple deadlines while maintaining high quality workmanship.
Please send a resume and cover letter to firstname.lastname@example.org