Role Summary:
Fore Bio is a next-generation precision oncology company focused on the development of plixorafenib, an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. The Scientific Director will have a highly cross functional role supporting the clinical development programs by contributing to the design, data collection and reporting of clinical studies. This role may interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors representing Fore Bio both internally and externally.
Strong experience in implementation of trial specific activities is a must for this versatile position.
Essential Duties and Responsibilities
:
- Plans, and executes program level activities for the Plixorafenib program to establish consistency across all studies in regard to execution, data quality and integrity.
- Works closely with the Medical Monitor of the studies for seamless conduct of the program.
- Mentoring and supervising junior clinical scientists while simultaneously having direct responsibility of day-to-day conduct of the studies.
- Supports activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensures consistent, quality data review
- Tracks and identifies clinical data trends; provides trends and escalates questions to the Clinical Development Lead; provides support on Study committee (e.g., DMC) activities and other major study milestones such as interim analyses, data sweeps, and data base lock.
- Maintains a thorough understanding of assigned protocols, educates supporting team members and the CRO on these protocols.
- Participates in protocol and ICF development process including: reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality
- Supports annual IB and DSUR updates
- Participates in CSR development in conjunction with Clinical Development Team; reviews clinical narratives
- Reviews and develops site and CRA training materials and presentations for SIV and Investigator meetings and to support study committees (e.g., DMC)
- Reviews development of site and CRA training materials related to data quality and integrity of the clinical and safety database
- Contributes to and conducts review of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Supports cross functional team in conduct of the study functions including Clinical Operations; Safety; Clinical Pharmacology, Biostatistics and Regulatory.
- Leads, plans, and executes trial level activities independently working closely with the Medical Monitor.
- Provides scientific and clinical leadership to support Clinical Operations
- Maintains a thorough understanding of assigned protocols and educates both supporting team members and the CRO on them.
- May include site-facing activities primarily related to safety including queries or discussions of causality, seriousness, and to ensure that the clinical narrative is accurate and complete, to provide training and guidance to investigators/sites on definitions related to assessment of safety. Activities related to data accuracy and analysis, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting clinical development, operations, and data management team in a matrix organization
- Development of key documents for study conduct BICR charter, Steering committee charter etc.
- Perform review and provide input to different documents e.g. Trial Protocols and amendments, Clinical Study Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator's Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, etc
- Travel up to 10% of time, based upon program needs
Education and/or Work Experience Requirements:
- PhD, PharmD or APN equivalent in a scientific or health care field required
- Will consider an equivalent combination of BA/BS/RN degree and experience
- Minimum 10 yrs of pharmaceutical/biotech industry clinical research experience
- Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator’s Brochures), as well as scientific publication and presentations.
- Experience in oncology required.
- Global Health Authority interaction including document preparation experience required; NDA experience preferred.
- Strong medical writing skills: takes ownership of documents, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
- Excellent knowledge of drug development process
- Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
- Knowledge of and experience in clinical development.
- Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
- Ability to develop collaborative working relationships with contracted vendors.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Fore Biotherapeutics is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
