Senior Director, Clinical Development

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.

Key Responsibilities

• Prepare clinical development plans according to the nature of the clinical project and its objectives (e.g., exploratory research, support a marketing authorization application, marketing and commercialization support, new indication); ensuring compliance with ICH-GCP, medical device guidelines, regulations and agreed quality standards.
• Responsible for overall management of a product portfolio (e.g., multiple indications for the same product) based on the clinical development plan.
• Oversee protocol development from concept to final protocol and protocol execution, including interaction with key opinion leaders and investigators.
• Serve as sponsor contact for key study sites on protocol related topics; act as an escalation point for the Clinical Development team and participate in CRO Executive Governance meetings as required.
• Serve as a mentor and provide line management for junior level staff, if required.
• Manage budgetary responsibilities for programs overseen by direct reports.
• Act as Medical Monitor or point of contact for CRO Medical Monitor for assigned clinical trials, overseeing participant inclusion into the study and provide backup Medical Monitoring support for direct reports as needed.
• Write, edit, and review medical and scientific elements of internal and external facing documents (clinical research, development plans, operational and regulatory documents such as study synopses, protocols, CRFs, informed consent templates, feasibility assessments, statistical analysis plans, clinical sections of regulatory documents (IND, MAA, NDA, PIP, DSUR, annual reports, regulatory designations), key study plans, and clinical study reports).
• Lead responses to competent authority questions and oversee study data reviews, liaise with data safety monitoring committees or other protocol directed committees, data analysis, and clinical study report authoring.
• Participate in multi-disciplinary project teams as the responsible individual of the project clinical development and presentation of the clinical trial results, aligned with Program Management when appropriate.
• Oversee and conduct ongoing medical and scientific review of clinical trial data with clinical scientific experts.
• Oversee creation and translation of Target Product Profile (TPP) into clinical strategy.
• Manage Key Opinion Leader and Medical Advisory Board interactions and identify Key Opinion Leaders as needed.
• Responsible for study medical and safety data aspects and risk-benefit assessments supported by the Pharmacovigilance team.
• Ensure study quality and manage internal clinical activities, assisting Clinical Operations with supervision of CRO activities by reviewing key study plans and performance, leading risk mitigation activities to ensure timely delivery of study results and reports that comply with applicable quality requirements.
• Escalate areas of concern to Clinical Development and Clinical Operations Heads as appropriate.
• Support business development activities, due diligence processes, and market access related to clinical development.
• Supervise clinical trial related activities delegated to or shared with the Clinical Project Manager.

Required Skills and Qualifications

• Education and Training: MD, DO, PhD, PharmD or equivalent degree or experience.
• Previous Experience: 7–10 years of demonstrated clinical research and clinical development experience, experience working with all drug/medical device development phases, infectious disease experience preferred.
• Abilities and Skills:
  • Working knowledge of the assigned disease area with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trials.
  • Working knowledge of region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.) and ICH GCP guidelines.
  • Working knowledge of clinical trial design and statistics.
  • Understanding of scientific methods and tools used in early clinical development, biomarkers, translational modeling, biostatistics, and the relevant clinical trial landscape.
  • Strong communication and oral presentation skills with ability to work in a cross-functional and global organization.
  • Highly organized and able to work within international environments with team members located in different locations and countries.
  • Ability to travel domestically and internationally as required (approximately 25%).
  • Strong project management and medical writing skills.
  • Proficiency in MS Office Suite (Word, Excel, PowerPoint) and Adobe Pro.
  • Alignment with the parent company’s group philosophy and ability to seek, understand, and incorporate different perspectives.
  • Ability to manage tasks, prioritize, and delegate decision-making authority appropriately.

The base compensation range for this role is $300–350K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity and business / economic conditions.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.