Sign upLog in

Senior Director, Clinical Development

Asahi Kasei Battery Separator Canada Corporation

Cary, North Carolina

Apply
JOB DETAILS
SALARY
$300,000–$350,000
SKILLS
Biotech and Pharmaceutical, Budgeting, Case Report Form (CRF), Clinical Data, Clinical Monitoring, Clinical Outcomes, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Community Health, Contract Research Organization (CRO), Cross-Functional, Data Analysis, Diversity, Drug Development, Feasibility Analysis, GCP (Good Clinical Practices), Healthcare, Healthcare Providers, Healthcare Quality, ICH Regulations, Informed Consent, Marketing Authorization Application (MAA), Medical Equipment, Medical Ethics, Medical Office Administration, Medical Writing, Medicine, Mentoring, Operations Planning, Product Management, Project Development, Project/Program Management, Quality Metrics, Regulations, Regulatory Reports, Standards of Care, Statistics, Team Player
LOCATION
Cary, North Carolina
POSTED
3 days ago
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.

Key Responsibilities
  • Prepare clinical development plans according to the nature of the clinical project and its objectives: exploratory research, support a marketing authorization application, marketing and commercialization support, new indication, etc., ensuring that all aspects of ICH-GCP, medical devices guidelines/regulations and agreed quality standards are complied with at all times.
  • 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.
  • Write, edit, and review medical and scientific elements of both internal and external facing documents inclusive of clinical research, clinical development plans, operational and regulatory documents, including but not limited to study synopses, protocols, CRFs, informed consent templates, feasibility assessments, statistical analysis plans, clinical sections of regulatory documents (e.g., IND, MAA, NDA, PIP, DSUR, annual reports, regulatory designations, etc.), key study plans, and clinical study reports to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency.
  • 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 an

About the Company

A

Asahi Kasei Battery Separator Canada Corporation

Resume Resources

Free Resume TemplatesFree Resume Builder