Clinical Scientist/ Clinical Development Partner, Infectious Disease

Clinical Scientist/ Clinical Development Partner, Infectious Disease

About the Role

We are seeking an experienced Clinical Scientist to join a dynamic Clinical Development organization focused on advancing innovative therapies in infectious disease. This is a high-impact role for a clinically and scientifically strong individual who thrives in a lean, entrepreneurial environment and is excited to take ownership of the day-to-day execution of clinical development programs.

The Clinical Scientist will serve as a key partner and right hand to the VP, Clinical Development, helping translate clinical development strategy into effective day-to-day execution. This individual will work closely with the VP, Clinical Development and cross-functional teams to manage clinical development activities, address protocol and study-related questions, represent Clinical Development in internal and external meetings, and ensure that decisions and action items move forward efficiently.

This role is particularly well suited to someone who has worked in a small or emerging biotech environment and is comfortable operating with a high degree of autonomy and accountability. The ideal candidate brings strong clinical development expertise, sound scientific judgment, and the ability to step into complex situations, determine what needs to happen, and drive the work forward.

The role is US-based. Experience working with APAC programs, sites, investigators, or regulatory environments is an advantage.

Key Responsibilities

Clinical Development Partnership

• Serve as a close day-to-day partner and trusted extension of the VP, Clinical Development.

• Help manage the execution of clinical development strategy across assigned infectious disease programs.

• Take ownership of day-to-day clinical development activities, ensuring priorities, decisions, and deliverables continue to move forward.

• Represent Clinical Development in cross-functional meetings and discussions, providing appropriate scientific and clinical input.

• Attend and actively contribute to meetings with Clinical Operations, Regulatory, Biometrics, Translational Medicine, Medical Affairs, CROs, investigators, and other stakeholders.

• Serve as a key point of contact for clinical development questions and appropriately triage issues to the VP, Clinical Development or other subject matter experts.

• Prepare the VP, Clinical Development for key meetings and decisions by synthesizing relevant information, identifying issues, and developing potential paths forward.

• Follow through on decisions and action items to ensure effective execution.

Protocol Development & Clinical Strategy

• Provide clinical development expertise throughout protocol development, review, and implementation.

• Lead or support protocol development and review, including assessment of study objectives, endpoints, eligibility criteria, treatment schedules, assessments, and operational feasibility.

• Evaluate protocol questions arising during study execution and work with appropriate stakeholders to develop scientifically sound, practical responses.

• Support interpretation of emerging clinical data and its implications for ongoing study execution and future development.

• Partner with the VP, Clinical Development on study strategy while taking ownership of many of the day-to-day activities required to execute that strategy.

• Identify potential clinical development issues early and proactively recommend solutions.

• Contribute to clinical development plans, study concepts, clinical protocols, investigator materials, and other key program documents.

• Support preparation of clinical development presentations and materials for internal governance and external interactions.

Clinical Trial Support

• Work closely with Clinical Operations to support successful execution of clinical trials.

• Provide clinical development input on study start-up, site questions, enrollment challenges, protocol implementation, and study conduct.

• Help ensure that clinical trial teams have clear, timely responses to protocol and clinical questions.

• Review and provide input on clinical trial documents, including protocols, amendments, informed consent materials, investigator materials, study plans, and other relevant documentation.

• Partner with Clinical Operations and CRO teams to identify trends, issues, and opportunities requiring clinical development input.

• Participate in investigator and site meetings as a Clinical Development representative.

• Help ensure consistency in clinical interpretation and communication across study teams and geographies.

Cross-Functional Leadership & Representation

• Serve as a Clinical Development representative in cross-functional project teams and working groups.

• Build strong relationships across Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, CMC, and other functions.

• Translate complex scientific and clinical concepts into clear recommendations and actionable decisions.

• Facilitate alignment across functions and help resolve issues that cross organizational boundaries.

• Act as a knowledgeable clinical development resource for colleagues who may have strong scientific or translational expertise but less experience with clinical development execution.

• Bring clinical development perspective to program discussions and help connect translational science with clinical strategy and execution.

Day-to-Day Program Ownership

• Maintain visibility across clinical development activities, upcoming milestones, key decisions, and outstanding issues.

• Proactively identify what requires attention and independently drive appropriate next steps.

• Manage multiple priorities in a fast-moving environment without losing focus on critical program objectives.

• Develop solutions when processes, responsibilities, or answers are not clearly defined.

• Take accountability for deliverables rather than simply coordinating activities.

• Escalate issues appropriately while maintaining ownership through resolution.

• Help create structure and operational discipline as the clinical development organization and portfolio grow.

Qualifications

• Advanced degree in a relevant scientific or clinical discipline, such as PharmD, PhD, MS, MPH, or equivalent; an MD is not required.

• 5+ years of relevant experience in clinical development, clinical science, or a closely related field within the biopharmaceutical industry.

• Demonstrated experience supporting clinical development programs from protocol development through clinical trial execution.

• Strong understanding of clinical development principles, clinical trial design, protocol development, and study conduct.

• Experience in infectious disease is strongly preferred.

• Experience working in a small, emerging, or entrepreneurial biotech environment is highly desirable.

• Ability to independently manage substantial portions of day-to-day clinical development activities and operate as a trusted partner to senior clinical development leadership.

• Strong ability to evaluate protocol and clinical questions, identify the appropriate path forward, and engage the right stakeholders.

• Excellent scientific and clinical judgment with the ability to distinguish issues requiring senior medical input from those that can be independently addressed.

• Strong written and verbal communication skills, including the ability to effectively represent Clinical Development in meetings.

• Demonstrated ability to work cross-functionally and influence without formal authority.

• Highly organized, proactive, and comfortable managing multiple priorities in a rapidly evolving environment.

• Experience with APAC clinical development, clinical trials, investigators, or regulatory considerations is a plus.

What Success Looks Like

Success in this role will mean becoming a trusted and highly effective extension of the VP, Clinical Development.

The successful candidate will understand what needs to happen across the clinical development program, proactively identify issues, and take ownership of getting the work done. They will be comfortable sitting in meetings and representing Clinical Development, answering protocol and study questions, coordinating with cross-functional partners, and knowing when an issue requires escalation to the VP or medical lead.

This person will allow the VP, Clinical Development to remain focused on overall clinical strategy, key scientific and medical decisions, and senior-level representation, while providing strong clinical development expertise and ownership of the day-to-day work required to execute the program.

The ideal candidate is a hands-on clinical development expert who can operate independently, think strategically, and thrive in an environment where accountability and initiative are highly valued.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.