Clinical Director Jobs

About The Position

Requirements

• PhD, PharmD or other related Advanced Medical Scientific Degree.
• Experience in oncology is a must.
• At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents.
• Ability to critically review and interpret Clinical data.
• Working knowledge of the drug development process in the USA and EU is required.
• Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
• Ability to follow independently delegated activity linked to clinical research scientist function, communicate progress and understand timelines.

Responsibilities

• Assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.
• Serving in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials.
• Assisting the Clinical Research Scientist Manager to contribute to CRS process improvement, as needed.
• Using medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures.
• Assisting the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages).
• Working with the medical lead to prepare presentations (internal and external), abstracts, manuscripts.
• Inputting into the of ICF/reviews ICF.
• Working with data management on CRF design and completion guide.
• Partnering with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan.
• Reviewing protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raising queries and coordinating with the medical lead.
• Reviewing safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations.
• Collaborating with the medical lead to provide medical/scientific guidance during the execution of the study.
• Ensuring TMF compliance for clinical development/medical study level TMF documents.
• Answering specific site protocol questions as needed, after consultation with the medical lead.
• Developing specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead.
• Escalating protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member.
• Reviewing the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead.
• Reviewing the CSR (interim; final; addendum), in collaboration with the medical writer and medical lead and/or any related publications (abstracts; presentations at meetings or publications in scientific journals) in relation with medical writer and medical lead.
• Assisting in any other asset activities requiring clinical/ scientific expertise.

Benefits

• 401(k) eligibility
• various paid time off benefits, such as vacation, sick time, and parental leave