Director, Clinical Development Scientist

About Us

About the Role

The Director, Clinical Development Scientist will be the clinical and medical primary lead to support the APAC region for our lead program, Myasthenia Gravis (gMG).

Reporting to the Sr. Director, Clinical Development gMG lead, you will steer the preparation, review and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports; review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation and data mining, and ensure assigned studies are conducted according to GCPs and SOPs. You will act as the medical monitor in close collaboration with the CRO medical and clinical monitors, ensure timely recruitment in collaboration with clinical operations, oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data. You must have experience with Rare Diseases or Neurology within the biotechnology or pharmaceutical industries.  

This is a unique opportunity to join a growing organization with an expanding pipeline and lead clinical strategy for auto-immune neurology indications. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Leading 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 the 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.

Experience

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