Note: The job is a remote job and is open to candidates in USA. Sensorium Therapeutics is a biopharmaceutical company developing clinical therapies and pipeline programs. The Vice President of Clinical Development will lead the clinical development strategy and clinical-related activities for SNTX-2643, oversee Phase 1–3 studies and clinical vendors, and provide strategic guidance across clinical development initiatives. The role also involves cross-functional collaboration, engagement with investigators and key opinion leaders, and ensuring the medical and scientific quality of company activities.
Responsibilities
- Provides leadership to SNTX-2643 clinical team members in support of clinical development strategic needs
- Collaborates with the Chief Medical Officer to support pipeline Clinical Development strategy and activities, but is not directly responsible for pipeline strategy or activities
- Maintains and provides subject matter expertise as Clinical Development lead for SNTX-2643
- Collaborates with Finance, Research and Development, and business development to translate clinical insights and data gaps into corporate strategy
- Cultivates partnerships with cross-functional partners such as platform, pre-clinical, CMC, pharmacovigilance, regulatory, operations, program management, and finance to provide clinical leadership in support of relevant therapeutic and disease area initiatives
- Works closely with Regulatory and Clinical Operations to ensure optimal collaboration and the inclusion of external clinicians and KOLs in clinical trial planning, enrollment, and interpretation
- Interacts with investigators, KOLs, research institutions, and internal Sensorium departments to oversee and facilitate Clinical Development objectives, ensuring the medical and scientific merit of company activities
- Supports short- and long-term goals of Clinical Development with respect to the prioritization of research interests and of desired collaborations with specific investigators and institutions
- Ensures alignment of SNTX-2643 clinical development activities with corporate strategy, program plans, and objectives
- Provides oversight and leadership in the review and approval of external resources, communications, and publications to ensure medical accuracy, objectivity, and fair balance
- Facilitates cross-functional teams in performing post-hoc data analyses and identifying opportunities to address clinical data gaps
- Manages and regularly meets with a network of national thought leaders to support the successful execution of Clinical Development tactics
- Represents Sensorium at scientific and clinical congress meetings
- Interacts with other departments including business development, finance, pharmacovigilance, legal, and regulatory
Skills
- MD or DO, or PhD/PharmD required
- Minimum of 10 years of biopharmaceutical industry clinical development experience, with a strong track record of successful clinical program execution in the field of CNS/Psychiatry
- Experience with Phases 1-3 clinical development; knowledge and experience of building clinical development infrastructure aligned with the needs of an early-stage growing organization
- Working knowledge of ICH/GCP/FDA requirements and applicable global regulatory expectations, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents
- Understanding of the general healthcare environment in and outside of the US, including laws, regulations, and evolving market access trends and issues
- Demonstrated CNS clinical development experience, with psychiatry or neuropsychiatry strongly preferred (anxiety, mood, or related indications)
- Experience with acute or rapid-onset treatment paradigms and the design and endpoint challenges they create, including challenge or provocation models
- Familiarity with CNS biomarkers, including quantitative EEG, and with pharmacokinetic and pharmacodynamic modeling as a decision-making tool
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies highly desired
Benefits
- Performance bonus and equity
- Medical, dental, and vision coverage for employees and dependents
- 401(k)
- Company-paid life and disability insurance
- Unlimited paid time off, company holidays, and paid parental leave
- Support for scientific conferences, continuing medical education, and professional development
- This position is remote and open to candidates anywhere in the United States
- Candidates who prefer a Boston-area hybrid arrangement are equally welcome
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