About Sonoma Biotherapeutics:

Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative 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 Sr Medical Director strategically directs clinical development programs throughout the evolution of the clinical trial design, execution, and completion of the study, providing medical and technical leadership. The Sr Medical Director is also responsible for supporting medical functions of the department, supporting new approvals, support and writing of regulatory reports and peer-reviewed manuscripts/abstracts/presentations. The Sr Medical Director participates on division strategic teams including for the identification of new therapeutic indications for existing products as well as new therapeutic areas.

The Sr Medical Director will provide medical technical expertise to the Business Development and Portfolio Management functions in the identification of potential partnering and lifecycle options. The Sr Medical Director shares medical expertise with his/her counterparts in other functional areas (e.g. regulatory affairs, research, drug safety, clinical operations, etc.). The Sr Medical Director will also provide input into clinical research strategy and conduct clinical trials for early, late, and marketed therapeutics. Sr Medical Directors are expected to perform their responsibilities independently and are able to lead multiple projects. The Sr Medical Director is able to function with independence and has strategic input into the functions goals, initiative, and programs.

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Matrixed Team Leadership & Talent Management

• Leads or is a standing member of the Clinical Science Team (CST)
• Effectively delegates representation in matrixed teams relevant to assigned molecule(s)/indication(s), and is accountable for ensuring cross-functional integration, coordination and alignment to enable effective and efficient CDP execution
• When assigned/appointed, acts as the temporary Program Lead and represents the function on core teams
• Accountable for training new CST members
• May also, as appropriate, support relevant sub-teams in assigning and orienting new team members to the team/NME
• As appropriate, participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources
• As needed, assists with recruitment, training, and/or coaching of new or less experienced staff members
• Where applicable, manages direct reports and is, in such instances, accountable for hiring, training, developing and retaining talent on his/her staff.

2. Clinical Development Planning

• Has in-depth knowledge of internal and external developments, trends and other dynamics relevant to the work of the function, as well as the portfolio, to maintain a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s). Strategically incorporates this information into his/her programs.
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Leads clinical and/or disease strategy development, collaborating with a variety of internal and external partners and stakeholders, such as clinical investigators, scientists, and key opinion leaders, as well as multidisciplinary internal groups, including other groups in global functions such as research, clinical operations, drug safety, regulatory, portfolio management, business development, Product Development, market planning, legal, etc.
• Creates and implements, or delegates creation and implementation of, the CDP for assigned molecule(s)/indication(s) and/or other programs:
• Accountable to ensure strategic and operational alignment of the CDP with the relevant strategic context
• Directs and/or oversees CST and guides relevant sub-teams 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 other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CDP
• Participates in competitive intelligence and/or other market/industry assessment activities and projects as appropriate
• As assigned, acts as a consultant to Business Development on relevant acquisitions, joint ventures or other strategic partnerships
• Communicates with HAs, as and when needed or otherwise appropriate. Ethically, effectively and professionally represents the interests of the company and patients. Conducts health authority interactions with little or no supervision.
• Represents the function for the assigned molecule(s)/indication(s) to other internal groups
• Acts as a regular reviewer/presenter to various internal committees
• Contributes clinical science input into the relevant therapeutic/disease area scientific strategy. Helps research and other relevant groups ensure consistency of scientific and development strategies with TPPs and corporate goals. As appropriate/needed, performs clinical assessments on relevant drug discovery projects.

3. Clinical Development Plan Implementation

• Accountable for CDP execution: objectives and deliverables are consistently accomplished in a timely, on-target and high-quality manner within budget guidance
• Provides clinical oversight across all relevant studies and programs:
• Designs clinical studies and develops protocols
• Acts as medical monitor for assigned studies
• Supports clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions regarding assigned studies
• May contribute to the identification and selection of appropriate external investigators and sites
• Acts as clinical lead in the development of study analytics and data management plans
• Conducts or oversees ongoing reviews of study medical/safety data
• Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicates any issues, challenges and potential strategies for resolution
• Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study
• Collaborates with other groups to ensure timely and appropriate completion of interim study reporting
• Collaborates with clinical operations to close-out clinical studies, secure data and complete study reporting
• Accountable to 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
• Plays a lead role in development/revision of investigator brochures, presentations and other materials
• Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
• Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.
• Represents the function in key advisory boards and other external presentations, meetings and other communications. Develops and delivers key presentations, internally and externally, 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 ECD studies or other programs and recommend new or modified ECD studies in the assigned therapeutic area
• Completes and/or leads other special projects, initiative, or organizational goals as assigned
• Consistently complies with all governing laws, regulations, the Company Standard Operating Procedures and other guidelines, and ensures the same among relevant team members

4. QUALIFICATIONS & EXPERIENCE:

• MD with relevant medical experience in same/similar therapeutic area
• 5 years’ pharma/biotech industry experience OR is a recognized clinician-scientist expert in the field with equivalent clinical or laboratory research experience. Industry experience is strongly preferred
• 3 years’ experience with clinical trials. In-depth understanding of Phase I – III drug development
• Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance
• Comprehensive understanding of product and safety profiles
• In-depth knowledge of medical aspects of Good Clinical Practice, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, FDA, EMEA, etc.
• In-depth understanding of competitive activity in the field
• In-depth experience submitting an IND, NDA/BLA/MA to regulatory authorities
• In-depth experience authoring a global clinical development plan
• In-depth experience publishing results of clinical drug trials in a refereed journal
• Preferred: Academic/teaching background with research experience (clinical or laboratory)
• Preferred: Previous management experience