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SERB Pharmaceuticals is a specialty pharmaceutical platform focused on critical care and rare diseases. The company brings together SERB, BTG Specialty Pharmaceuticals, and Veriton Pharma to develop and provide treatments for complex, life-threatening conditions. Its work supports clinicians and healthcare systems while addressing significant unmet needs for patients and their families, making SERB Pharmaceuticals relevant to professionals exploring careers in specialty pharmaceuticals, healthcare, and manufacturing.
Manager, Clinical Development (Onsite)
Lead sponsored and investigator-initiated clinical trials for SERB Pharmaceuticals, supporting studies for medicines addressing rare and urgent conditions.
Description
- Oversee company-sponsored and investigator-initiated studies in line with company SOPs and applicable regulations
- Ensure assigned clinical research projects follow approved protocols, Good Clinical Practice standards, and relevant regulations
- Manage outsourced activities, service providers, and contractor relationships through appropriate vendor oversight
- Prepare study materials such as synopses, protocols, informed consent forms, and study plans
- Develop clinical study budgets and oversee delivery within approved financial parameters
- Obtain required regulatory documentation from study sites and maintain complete study files in accordance with GCP and SOP requirements
- Review and update standard operating procedures when needed
- Partner with legal teams and study sites to negotiate contracts for investigator-initiated research
- Stay informed about FDA requirements, Good Clinical Practice, and ICH guidelines
- Maintain ethical and professional standards in all interactions while reflecting BTG values
- Complete additional clinical-function assignments from the Line Manager
Requirements
- Bachelor’s degree or higher in a health-related discipline
- At least three years of direct clinical trial experience within a CRO or research-focused organization
- Experience with in-vitro diagnostic studies is advantageous
- Experience working in the European Union is advantageous
- Ability to work independently with confidence and collaborate effectively within a team
- Understanding of clinical research activities from Phase I through regulatory submission
- Strong written and verbal communication skills for conveying complex information
- Experience managing contracts and timelines is preferred
- Highly organized with strong interpersonal skills
- Positive, adaptable approach with the ability to coordinate study activities across staff levels
- Capacity to manage competing priorities across multiple clinical trials
- Independent judgment to evaluate clinical situations and recommend appropriate solutions
- Ability to establish baseline targets, monitor trends, and implement mitigation plans
- Familiarity with fundamental data-processing activities, including electronic data capture
- Working knowledge of current ICH Good Clinical Practice guidelines
Benefits
- Vacation, personal, and sick leave
- 15 company-paid holidays
- Medical, dental, vision, and other voluntary benefit options
- Paid parental leave
- Tuition assistance
- Discretionary bonus program
- 401(k) plan with a dollar-for-dollar company match on contributions up to 6% of pay
- Safe-harbor 401(k) match that is immediately vested
- Discretionary 401(k) match of up to 4% of pay, vesting at 20% annually over five years
- Competitive compensation and benefits packages
- Supportive culture centered on collaboration
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