About the Role

The Clinical Scientist/Clinical Trial Manager (CS-CTM) is an important member of the Immorna US Clinical team. This person will provide both scientific guidance and operational support in  the planning and execution of early and/or late phase clinical studies. Operational accountabilities include serving as the company’s point of contact to manage CROs and other external vendors, collaborating with the Clinical Project Manager to manage budgets, timelines and resources, and providing oversight and guidance for Clinical Research Associates and/or Clinical Trial Specialists. This person will also provide scientific input into design & implementation of clinical trials, clinical data review and data cleaning, interpretation of results, data reporting and presentation, and activities required for worldwide registration of a product (i.e., clinical input to IND/NDA/BLA).

This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to Immorna. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice (GCP) and regulatory requirements. This person will need to be flexible and adaptable to new responsibilities as opportunities arise in the organization.

• Leads the development of clinical protocols and related documents. Reviews documents to ensure quality and compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.

• Is accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its approval.
• Supports the development of clinical components of regulatory and EC/IRB submission documents. Prepares and provides input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, regulatory responses).
• Provides clinical/scientific input into design & implementation of clinical trials, their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to IND/NDA/BLA).
• Manages CROs for clinical trial(s), including collaboration with Project Manager to set targets for clinical monitoring staff and ensuring the recording of trial in compliance with project goals in alignment with company’s goals.
• Establishes key relationships internally with clinical project teams, preclinical and CMC teams, and externally with investigators/KOLs and external service providers.
• Leads/supports cross functional projects to ensure the successful passage of drugs through all phases of the drug development processes.
• Reviews and interprets medical data and clinical trial data and draws conclusions with Medical Director/Physician Lead/Chief Medical Officer.
• Is responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.

• Creates and implements study-specific clinical monitoring tools and documents.
• Creates and provides oversight for the clinical study budget.

Minimum Qualifications:

• Bachelor’s or higher degree in relevant field (e.g., nursing or life sciences).
• Industry or Academic experience in drug development required with experience in Infectious Diseases and/or Oncology clinical trials strongly preferred.
• Relevant clinical trial work experience for a pharmaceutical/biotech company.
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research.
• Possesses general knowledge of 1) medical monitoring 2) regulatory approval process in relevant countries, especially in the US; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
• Possesses the ability to drive/contribute to protocol design, writing and implementation. Possesses the ability to work independently and prioritize duties.
• Has a can-do attitude and result-driven mindset.
• Outstanding communication skills, both verbal and written, in English. Bilingual, English and Mandarin, is a plus.
• Sufficient technical knowledge to be able to interact with internal and external partners.
• Experience in developing SOPs for clinical trials.
• Proficient with Microsoft Office Word, Excel, virtual meeting platforms etc.
• Understanding of Electronic Data Capture (EDC), CRF, Medidata RAVE.

This position can be fully remote, with minimal occasional travel (< 10%). Candidates  must be located in Maryland, Massachusetts, or North Carolina.

Benefits Offered

• Medical / Dental / Vision
• 401k - company match of up to 6% of employee base salary contribution
• Life Insurance
• Paid Time Off – Major US Holidays + 15 Working Days / Year
• Umlimited sick leave

Please send your CV to us-hr@immorna.com