Senior Director, Clinical Development

Responsibilities

• Responsible for overall management of a product portfolio (i.e., multiple indications for the same product), as needed, based on the clinical development plan.
• Oversee protocol development from concept to final protocol. Protocol execution including interaction with key opinion leaders/ investigator(s). May serve as sponsor contact for key study sites on protocol related topics.
• Serve as an escalation point for the Clinical Development team; participates in CRO Executive Governance meetings, as required.
• Serve as a mentor and provides line management for junior level staff, if required.
• Budgetary responsibilities for programs direct reports are overseeing.
• May serve as Medical Monitor or point of contact for CRO Medical Monitor for assigned clinical trials overseeing participant inclusion into the study. Provides back-up Medical Monitoring support for direct reports, as required.
• Lead responses to competent authority questions, as requested.
• Oversee study data reviews, liaise with data safety monitoring committees or other protocol directed committees, data analysis, and clinical study report authoring.
• Participate in the multi-disciplinary project team as the responsible individual of the project clinical development and presentation of the clinical trial results, aligned with Program Management when appropriate (teams and committees).
• Oversee/conduct ongoing medical and scientific review of clinical trial data with clinical scientific expert(s).
• Oversee creation and translation of Target Product Profile (TPP) into clinical strategy.
• Manage Key Opinion Leader and Medical Advisory Board interactions. Identify Key Opinion Leaders, as needed.
• Responsible for study medical/ safety data aspects and risk-benefit assessments supported by Pharmacovigilance team.
• Ensure study quality and manage internal clinical activities. Assist Clinical Operations with supervision of activities of contract research organizations by reviewing key study pl

Benefits

Additional Information

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility. Company: Veloxis Pharmaceuticals, Inc. Job Description: The Sr. Director, Clinical Development is responsible for ethical, medical, and scientific rigor in supporting the development, conduct, and reporting of assigned clinical development portfolio across all stages of drug development and commercialization. This position is responsible for medical and scientific quality in the design, planning, initiation, and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development. As a leader of the Clinical Development department, this position may have line management accountability for Clinical Development staff.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at akamerica? Share your experience