Director of Clinical Science
Join a fast-paced, collaborative, cutting-edge start-up biotechnology company developing the next generation of therapeutic bispecific antibodies focused on extracellular protein degradation. Our mission is to generate novel transformative medicines for the patients that need it most. The Director of Clinical Science will strategize and execute a clinical development plan, starting from IND through phase 2 studies. 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.
Day-to-day responsibilities may include:
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. Develops subordinates' skills and encourages growth by providing relevant feedback and coaching. Carries out required performance management processes responsibilities and actively supports employee development. Identifies and manages disciplinary situations or employee conflict
Other Duties:
Travel to client or prospect locations, conferences, or other professional development and networking events
Required Education / Experience and Skills:
Advanced scientific or clinical degree (e.g., PhD, PharmD, MPH, MD, 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.
Able to travel (<20%)
Job level will be based on prior experience and accomplishment. The expected base salary range for the Director of Clinical Science role is $202,500-$247,500.
The above pay range is what we reasonably expect to pay for this position. Individual compensation is based on various factors, including experience, education, skillset, and geographic location. This pay range is for the Bay Area, CA, location and may be adjusted to the labor market in other geographic areas.
Benefits & Perks:
Comprehensive and competitive health, vision, dental, life insurance
Competitive base pay, bonus, and equity package
Unlimited PTO, Paid Holidays and Winter Break
10 weeks Parental Bonding Leave
Epi 401(k) Plan
EpiBiologics is an Equal Opportunity Employer:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you think you will excel in this role, but perhaps don’t tick every box, we encourage you to apply!
Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation.