Clinical Development Manager Jobs in Kentucky (NOW HIRING)

Job Title: Clinical Development Scientist

Location: Boston, MA or New Haven, CT

Introduction to role:Are you ready to turn complex clinical data into confident decisions that accelerate life-changing medicines for people with severe, underserved conditions? As a Clinical Development Scientist based in Boston or New Haven, you will sit at the center of a cross-functional study team, strengthening study quality, safeguarding data integrity, and ensuring inspection readiness across critical programs.

You will connect protocol design, real-time data review, and operational execution—transforming signals into actions and actions into impact. From day one, you will help shape high-value trials, spotlight safety and efficacy trends early, and enable clear, timely decisions. Do you thrive at the intersection of science, operations, and data, guiding teams through complex questions with evidence and empathy?

Accountabilities:

• Protocol and Study Document Leadership: Contribute to the development of clinical study protocols, operations manuals, charters, monitoring plans, and other essential documents that enable efficient, inspection-ready execution.
• Safety and Efficacy Surveillance: Continuously monitor safety and efficacy data; escalate emerging concerns that warrant team awareness and intervention to protect participants and timelines.
• Data Analytics for Quality: Use Medidata Rave, Elluminate, and related tools to detect gaps or inconsistencies across key datasets and drive corrective actions that improve data integrity.
• Deviation Management: Investigate protocol deviations, identify root causes, and implement mitigations to prevent recurrence.
• Stakeholder Engagement: Proactively collaborate with the internal study team, site staff, investigators, and CRO personnel to enable high-quality execution and consistent inspection readiness.
• Trial Guidance and Issue Resolution: Serve as a point of contact for CRAs/CROs on protocol and trial procedure questions; manage and resolve issues that could impede study conduct.
• Clinical Development Planning: Support the design and execution of key elements of the Clinical Development Plan, aligning evidence generation with program strategy and regulatory needs.
• External Landscape Awareness: Maintain awareness of scientific, clinical, competitive, and regulatory developments that could impact the development plan and advise the team accordingly.
• Publications: Support development of publications arising from internal studies and related initiatives, ensuring scientific rigor and clarity.
• Business Development Support: Provide scientific support for due diligence and research collaborations to inform portfolio opportunities.

Essential Skills/Experience:

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree required)
• 2+ years of experience in designing and executing clinical trials
• Knowledge in the principles of literature search, clinical research methodology, statistics, data analysis and interpretation
• Ability to communicate clearly to internal and external stakeholders
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists

Desirable Skills/Experience:

• Advanced knowledge of the therapeutic area (Rare Disease Cardiology & Amyloidosis)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That\'s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\'re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Here, mission meets momentum. You will work with clinicians, statisticians, data scientists, and operational experts who challenge each other in the same room to unlock new ideas that directly influence study decisions and, ultimately, patient outcomes. We combine the agility of innovative biotech teams with the resources and reach of a global biopharma, translating brave science into robust, ethical evidence at pace. We value kindness alongside ambition—your voice will be heard, your growth nurtured, and your impact felt in programs that matter to people and families living with devastating conditions.Bring your scientific rigor and operational savvy to a team turning evidence into impact—share your resume today and help shape what comes next!

The annual base pay (or hourly rate of compensation) for this position ranges from $203,709.60 -$305,564.40 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.