Manager, Clinical Development

About the role

Critical Needs. Immediate Action. SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure. We operate end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, emergency care, and medical countermeasures reach patients and clinicians with urgency – wherever and whenever they are needed. Shaped over the past 25 years by an entrepreneurial, disruptive spirit, SERB combines the focus and agility of a biotech with the scale, reach, and reliability of a global pharmaceutical company — always grounded in medical purpose, not corporate convention. Our 600+ employees are driven by three core values: Patients first, always Patients are not a concept — they are why we act, especially when time matters most. Impact focused We are agile, entrepreneurial, and disciplined - working smart and learning continuously to deliver results that matter, with the consistency, quality, and trust that critical care demands. Team powered We go the extra mile - together - because our shared commitment drives extraordinary outcomes. Guided by a clear ambition and a relentless focus on patients, SERB continues to expand through selective, innovative acquisitions, launching new treatments and entering new geographies. Across every step — from integration to delivery — our people act with passion, ownership, and determination to ensure life-saving medicines become available to patients who need them, worldwide. The Manager, Clinical Development is accountable for the overall operation of clinical studies including project planning, budget, resource management and contract research organization contact within the overall context of an approved clinical operational plan for the portfolio of products that are consistent with lifecycle program/company goals.

Responsibilities

• Manage all aspects for company sponsored and investigator-initiated studies (IISs) according to the applicable company Standard Operating Procedures (SOPs) and ensure all managed processes are compliant with internal SOPs and external regulations.
• Ensure that assigned clinical research projects comply with the clinical protocol, the most recent requirements for Good Clinical Practice (GCP) and other applicable regulations.
• Supervise outsourced tasks and services and manage contractor relationships ensuring appropriate oversight of vendors is maintained
• Drafting any necessary study documents such as synopsis, study protocols, informed consents and study plans as per company SOP’s.