Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of Treg cell therapies for autoimmune and neurodegenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of Treg cell therapeutic capabilities. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. More information at www.sonomabio.com.
The Medical Director
Directs clinical development programs throughout the evolution of the clinical trial design, execution, and completion of the studies, providing medical and technical leadership/expertise. Files INDs, supports and writes other regulatory reports, and writes peer-reviewed manuscripts/abstracts/ presentations. May also participate in business development opportunities and collaborative partnerships.
Shares medical expertise with his/her counterparts in other functional areas (e.g. regulatory affairs, research, drug safety, clinical operations, etc.). Provides input into clinical research strategy and how to conduct clinical trials for early and late-stage therapeutics. Performs responsibilities independently, leads multiple projects, and provides input into the function’s goals, initiative, and programs.
Primary Duties And Responsibilities
Matrixed Team Leadership & Talent Management
Leader/standing member of the clinical project team
Effectively delegates across matrixed teams; accountable for cross-functional integration, coordination, and alignment to enable effective and efficient CDP execution
May support relevant sub-teams in assigning and orienting new team members/NME
Participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools, etc
Assists with recruitment, training, coaching of new/less experienced staff members
May be responsible for hiring, training, developing and retaining talent per business needs
Clinical Development Planning (CDP)
In-depth knowledge of portfolio, developments, trends and other dynamics relevant to the function, to maintain a fully current view and perspective of internal/external influences and implications for assigned therapeutic/disease area(s)
Maintains the highest standards and levels of scientific and clinical knowledge
Leads clinical and/or disease strategy development, collaborating with internal and external partners and stakeholders: clinical investigators, scientists, KOLs, research, clinical operations, drug safety, regulatory, portfolio management, and business development.
Creates and implements the CDP:
Ensures strategic and operational alignment with the relevant strategic context
Directs, guides, and/or oversees clinical sub-team in developing all CDP components (e.g., analytics/data strategy, KOL development, safety monitoring, biomarker strategy, biologic and clinical proofs-of-concept, publication strategy, etc.)
Works with CST and others to assess resource requirements for implementing and executing the CDP
May participate in competitive intelligence and other market/industry assessment activities
Consults with business development on relevant acquisitions, joint ventures, or other strategic partnerships
Communicates with HAs; ethically, effectively and professionally represents the interests of the company and patients.
Represents the function for the assigned molecule(s)/indication(s) to other internal teams
Contributes clinical science input to the relevant therapeutic area scientific strategy. Helps research and others to ensure consistency of scientific and development strategies with TPPs and corporate goals. Performs clinical assessments on relevant drug discovery projects.
Clinical Development Plan Implementation
Accountable for CDP execution: accomplish objectives and deliverables in a consistent, timely, on-target, and high-quality manner within budget guidance
Provides clinical oversight across relevant studies and programs:
Designs clinical studies, develops protocols
Acts as medical monitor for assigned studies
Point of contact for questions and interactions
May contribute to the identification and selection of appropriate external investigators and sites
Clinical lead in the development of study analytics and data management plans
Conducts or oversees ongoing reviews of study medical/safety data
Collaborates to measure and monitor study progress, including any variances, and proactively communicates any issues, challenges and potential strategies for resolution
Ensures investigators are appropriately and thoroughly briefed on-time on study-related medical/scientific matters. Ensures timely and appropriate completion of interim study reporting through collaboration
Collaborates with clinical operations to close-out clinical studies, secure data, and complete study reporting
Ensure correct medical/scientific data interpretation for interim and final study reporting
Collaborates with drug safety representatives and others in the development of the product safety profile
Leads development/revision of investigator brochures, presentations and other materials
Leads the development and implementation of communications strategies to support existing and concluded studies - ie KOL interactions, advisory boards, major medical meetings, congresses and other events, publications, etc
Collaborates by providing clinical science information and input towards the completion and submission of regulatory filings and other regulatory documentation
Represents the function on key external advisory boards and presentations, meetings and communications. Develops and delivers key presentations to convey the company’s perspective and provide updates on strategies, plans and other activities
Drives ongoing data generation, review, and communication to inform or enhance the design or interpretation of Sonoma’s studies
Consistently complies with all governing laws, regulations, Company Standard Operating Procedures and other guidelines, and ensures the same among relevant team members
QUALIFICATIONS & EXPERIENCE:
MD. with relevant medical experience in immunology/autoimmune/rare disease or similar therapeutic area. Experience in cell/gene therapy is preferred.
3 years’ pharma/biotech industry experience OR a recognized clinician-scientist expert in the field with equivalent clinical/laboratory research experience.
Industry experience is preferred, as is extensive understanding of early clinical development phase I-II.
Broad experience in the principles of data analysis, interpretation and clinical relevance
Comprehensive understanding of product and safety profiles
In-depth experience or knowledge/understanding of the following:
Medical aspects of Good Clinical Practice, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, FDA, EMEA, etc.
Competitive activity in the field
Submission of IND (required), NDA/BLA/MA (preferred) to regulatory authorities
Authoring a global clinical development plan
Publishing results of clinical drug trials in a refereed journal
Preferred: Academic/teaching background with research experience (clinical or laboratory)
Seniority level
Director
Employment type
Full-time
Job function
Health Care Provider
Industries
Biotechnology Research
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