Clinical Trials Medical Director for a Bio-pharma startup- 2829

We are looking for a Medical Director to manages the clinical development of drug

candidates, including phase I-IV studies and across multiple therapeutic areas.

The Medical Director will have a strong understanding of all phases of pharmaceutical drug

product development, including clinical trial management, IND and NDA/BLA submissions,

medical monitoring, GCP principles, and will have extensive experience in collaboration with

Clinical Operations, Research and Clinical Pharmacology, Medical Affairs, Regulatory Affairs

and other key stakeholders.

Key responsibilities:

 Develop protocols to execute clinical development strategies.

 Work cooperatively with various clinical aspects and designated CROs to execute the

programs (e.g. lead study start up and database lock, performs data and coding reviews;

draft/present clinical slides for Investigators Meeting, Advisory Boards and

therapeutic/monitor training; review draft CRFs, etc.).

 Provides clinical leadership and medical strategic input for all clinical deliverables in the

assigned project or section of a clinical program if applicable.

 Clinical deliverables may include clinical sections of individual protocols, clinical data

review, program specific standards, clinical components of regulatory

s/registration dossiers, and publications.

 Leads development of clinical sections of trial and program level regulatory documents

(e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and

responses to Health Authorities) and supports all other Regulatory activities and

NDA/BLA related questions.

 Drives execution of the section of the clinical program in partnership with other line

functions (regulatory, clin ops).

 Acts as study medical monitor ensuring overall safety of the LBP for the assigned section,

and supports overall program safety reporting (e.g., Periodic Safety Update Reports

(PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in

collaboration with Patient Safety.

 Work with academic leaders/advisers to develop clinical strategy.

 Other duties commensurate with position as assigned.

 Ability to travel required.

Requirements:

 MD degree.

 Relevant sub-specialty (Medical Oncology) fellowship training – an Advantage.

 3-5 years experience with substantial knowledge of drug development and extensive

clinical research experience within the pharmaceutical/CRO industry in the specialist

therapeutic area.

 Equivalent academic experience can be substituted.

 Demonstrated ability to independently evaluate, interpret and present complex scientific

data.

 Demonstrated ability to critically evaluate complex drug development programs.

 Proven leadership and management experience.

 Demonstrated ability to work within a multi-disciplinary team of peers and outside experts.