The Clinical Scientist’s primary responsibilities include the design, and implementation of clinical protocols and reporting the results of clinical studies in compliance with regulatory requirements. They also provide clinical input during product development and failure investigations. The ideal candidate should be well-versed in product development, the clinical research process, regulatory requirements, and can manage large and complex sets of data. Their primary goal will be to ensure data and scientific integrity. A strong understanding of Good Clinical Practice (GCP) guidelines is required and will ensure all trials are conducted ethically and under these regulations.
ESSENTIAL JOB FUNCTIONS:
- Designing, implementing, and monitoring clinical trial(s).
- Lead clinical trial protocol development, and amendments.
- Work with Clinical Operations and Medical Directors to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
- Preparing and submitting necessary documentation for regulatory approvals and responses
- Drive & support preparation for data cleaning and cuts
- Cleaning, analyzing, and interpreting clinical data to determine the efficacy and safety of treatments or interventions
- Collaborating with cross-functional teams and stakeholders including but not limited to Clinical Development, Clinical Operations, Drug Safety, Biostatistics, Regulatory, Research and Biomarker groups
- Slide deck preparation for communicating clinical development plans, clinical trial timelines, clinical data
- Drafting and/or reviews for internal/external meetings and presentations, abstracts, posters, and coordinates reviews with internal partners and stakeholders
- Ensuring compliance with all legal and regulatory standards
- Collaborate with clinical teams on study site visits and protocol training
- Participating in study-specific project plan builds as required
- Identifying, assessing, and selecting study sites/PIs in partnership with CMO and Vendors (as applicable)
- Driving and overseeing CRO and other clinical vendor selection as applicable
- Lead cross-functional development teams, and clinical trial teams
- Ensuring cross-functional team project-specific training
- Contribute to Investigator Meetings, and Investigator/study calls
- Conducting literature reviews and staying updated with the latest clinical research trends and relevant product approvals
- Study specific participation in system set-up for Key Systems (e.g., IVRS, EDC, TMF, other)
- Leads collaborative teams for projects or groups both internal and external to business and across functional areas. Reacts well under pressure.
Other Duties
- Travel to client or prospect locations, conferences, or other professional development and networking events
- Attend staff, departmental, and other required meetings and trainings
- Partner with cross-functional peers & staff to build execution plans & meet critical business milestones
- Able to travel (<20%)
- Other duties as assigned
REQUIRED QUALIFICATIONS, EDUCATION & COMPETENCIES:
- Advanced scientific or clinical degree strongly ecouraged (e.g., PhD, PharmD, or MPH, etc.)
- 5 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry)
- Data listing review experience
- Experience authoring experimental protocols and/or study results and conclusions
- Relevant therapeutic area experience
- In-depth understanding of Phase I (and beyond) drug development
- Experience in the principles and techniques of data analysis and interpretation
- Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence
- Track record of working well with other scientists and clinicians is highly valued.
Computer and Equipment Skills
- Foundational computer skills, including Microsoft Office Suite and the Internet. Ability to navigate at a basic level within web-based applications
- Use of Outlook email and calendaring
- Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint, Access, and/or other web-based applications. May produce complex documents, perform analysis, and maintain databases
- Use of online teleconferencing software (e.g., Zoom or Teams)
BENEFITS:
- 401(k) Plan
- Flexible Vacation program for Exempt Employees plus 12 paid Holidays and Winter Break
- Up to 10 weeks of paid Parental Bonding Leave
- Medical, Dental and Vision, Company Funded HSA
- Company-paid short and long-term disability, and life insurance
- Voluntary life insurance plans are available for employees and dependents
All qualified applicants will receive consideration for employment without regard to race, color religion, disability, age, sex (including sexual orientation, gender identity and transgender status), national origin, veteran status, genetic information, or any other classification protected by federal, state, or local law. EpiBiologics is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities.
Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation.