Associate Director, Clinical Scientist
Role Overview
As part of Clinical Development and working closely with the Global Clinical Development Lead and Medical Director, the Clinical Research Scientist serves as the primary day-to-day clinical science contact for assigned studies.
The role leads and coordinates clinical science activities across study planning, protocol development and execution, data review and interpretation, and reporting, while ensuring cross-functional alignment and timely resolution and escalation of study-level issues.
The Clinical Research Scientist partners closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Patient Safety and provides clinical development input into regulatory responses, briefing books, and related documents.
The Medical Director retains ultimate accountability for medical oversight, final medical and scientific decisions, and external medical engagement.
Key Skills for This Role
Full Job Posting
Requirements:
- Academic degree (e.g., BS, BSN) in a relevant scientific or healthcare discipline. Advanced degree (MS, MPH, PhD, PharmD, MD, or equivalent) is strongly preferred.
- At least five years of experience in clinical drug development, in an academic or industry setting.
- Proven experience in the design, conduct, data review and interpretation of clinical trials; rare-disease experience is strongly preferred.
- Demonstrated ability to lead day-to-day study activities and coordinate complex cross-functional deliverables while maintaining clear accountability, priorities and timelines.
- Extensive experience authoring and reviewing clinical-trial protocols, amendments, informed consent forms, study manuals and other protocol-related documents.
- Strong experience with ongoing clinical-data review, data-cleaning processes, listings, protocol deviations, endpoint interpretation, database milestones and study-report development.
- Knowledge of regulatory and GCP requirements governing clinical trials, with experience supporting ethics committee, health authority or other external-agency interactions.
- Experience providing oversight to CROs and other external vendors and working in close partnership with Clinical Operations, Biostatistics and Data Management.
- Demonstrated ability to rapidly gain and leverage disease area and disease biology knowledge, to synthesize scientific literature and competitor information and apply it to development programs.
- Strong leadership, influencing and problem-solving skills, with the judgment to distinguish routine operational matters from issues requiring medical review or escalation.
- Highly effective scientific communicator with excellent written, oral and presentation skills, capable of training and aligning diverse internal and external stakeholders.
- Adaptable, collaborative and accountable team member who can work independently, manage ambiguity and deliver high-quality work to agreed timelines.
- Fluency in English, with excellent written and verbal communication skills.
- Willingness and ability to travel domestically and internationally up to 20% and to periodically report to the Basel or Boston office, depending on the role’s location.
- Ironwood currently anticipates that the initial base salary for this position could range from between $147,000-$175,000. The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.
Preferred Qualifications
- Academic degree (e.g., BS, BSN) in a relevant scientific or healthcare discipline. Advanced degree (MS, MPH, PhD, PharmD, MD, or equivalent) is strongly preferred.
- Proven experience in the design, conduct, data review and interpretation of clinical trials; rare-disease experience is strongly preferred.
- Ironwood currently anticipates that the initial base salary for this position could range from between $147,000-$175,000. The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.
About Ironwood Pharmaceuticals
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