Director, Clinical Development Scientist

Role Summary

The Director, Clinical Development Scientist serves as the clinical and medical lead for the APAC region on the lead program, Myasthenia Gravis (gMG). You will guide the preparation and review of clinical study synopses and protocols, investigator brochures, and clinical study reports; ensure studies are conducted in accordance with GCPs and SOPs; act as medical monitor in collaboration with CRO partners; oversee literature reviews, meta-analyses, and publication efforts. Experience in Rare Diseases or Neurology is required. Remote work is available.

Responsibilities

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Leading the development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Clinical Development program lead by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to relevant internal stakeholders to help shape the new indication selection process.
• Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders
• As a medical specialist, supporting and leading interactions with external and internal partners and decision boards.
• Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s.
• Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

Qualifications

• Required: MD, PhD, or PharmD.
• Required: Experience in clinical development.
• Preferred: Experience in rare diseases or neurology.
• Required: Proven ability to work with cross-functional teams, study vendors and clinical trial sites.
• Required: Strong business communication skills, written and verbal, and comfortable presenting internally and externally.
• Required: Thorough understanding of GCP/regulatory requirements.
• Required: Proactiveness — ability to identify challenges and risks and implement appropriate actions with some supervision.
• Required: Motivation — highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision.
• Required: Collaboration — coordinate activities of internal cross-functional study team as well as external vendors as applicable.
• Required: Open-mindedness — listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions.