Director / Senior Director, Clinical Development

About Us

About the Role

The Director, or Senior Medical Director (S)MD, Clinical Development will have significant impact in the overall success of our phase III trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Reporting to the VP, Clinical Development, the (S)MD, in conjunction with the VP, will lead the preparation, review and execution of clinical study protocols, data interpretation, and clinical study reports. You will act as the lead medical monitor with oversight of the CRO medical monitors and execution of the medical monitoring plan.

The (S)MD will work collaboratively to develop statistical analysis plans, informed consent forms, data listings, and lead the clinical development component of global regulatory filings and responses to health authorities and ethics committees. In addition, in collaboration with clinical operations, you will help ensure timely recruitment and that investigative sites are following the principles of GCP. You will also work with the medical safety colleagues to ensure the safety of trial participants including a lead role in interacting with the trial DSMB, reviewing ongoing data for potential safety trends, and evaluating cases of interest as they occur. The (S)MD will also guide colleagues through education forums on current medical and scientific trends while conducting literature searches and reviews, meta-analyses, and publishing data.  

This is an opportunity to join a growing organization with an expanding pipeline and drive 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 development program
• Leading development of clinical sections of trial and program level regulatory documents including authoring Clinical Trial Protocols and amendments, clinical study reports, statistical analysis plans
• Driving execution of the program and/or clinical trial in partnership with internal and external stakeholders
• Supporting the Vice President, Clinical Development by providing medical input into Clinical Development Plan for assigned programs
• Literature review, external expert interactions, attending and leading scientific meetings, advisory boards, and investigator meetings, and presenting the protocol to relevant internal and external stakeholders.
• Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, safety physicians, CRO medical monitors, and other external partners to oversee conduct of the assigned clinical trial/s
• Working closely with the internal and external stakeholders as well as developing strategies to help ensure timely recruitment.

Experience

• MD with board certification in the US, with clinical experience in Neurology or executing neurology clinical trials preferred.
• Previous experience leading industry supported clinical research in the pharma/biotech/CRO setting with familiarity with clinical study documentation, processes, and execution preferred.
• Strong ability to work with and lead cross functional study 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