Sr. Director, Clinical Development, Clinical Development Lead, Rheumatology

3 weeks ago

Cary, United States Asahi Kasei America Full time

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, Clinical Development Lead, Rheumatology("CDL") is responsible for leading the strategic planning and management of the Company's assigned clinical program(s) from an end-to-end clinical development perspective. The incumbent has oversight of the clinical development for the assigned programs and drive execution of the early to late phase clinical development plan. In addition, the incumbent enables an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

Summary of 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.
* Protocol development from concept to final protocol. Protocol execution including interaction with key opinion leaders/ investigator(s). Serve as sponsor contact for key study sites on protocol related topics.
* Serve as Medical Monitor with timely reviews of study data. Oversee subject inclusion, study data reviews, liaise with data safety monitoring 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 Project Leader when appropriate (teams and committees).
* Oversee/conduct ongoing medical and scientific review of clinical trial data with clinical scientific expert(s).
* Create and translate Target Product Profile (TPP) into clinical strategy.
* Prepare and/or review and approve essential study documents (Study Protocol, and Patient Information sheet, CRF, Clinical Study Report, etc.) and other study-related documents (study plans, etc.).
* Site engagement and recruitment engagement including site visits.
* Key Opinion Leader and Medical Advisory Board interactions and management.
* Responsible for study medical/ safety data aspects and risk-benefit assessments supported by Pharmacovigilance team.
* Ensure study quality and manage internal clinical activities and supervise the activities of contract research organizations by reviewing key study performance/quality and lead risk mitigation activities to ensure the timely delivery of study results and reports that comply with the applicable quality requirements and escalate areas of concern to Clinical Development Head as appropriate.
* Provide support to IB, IND/IMPD, CTD, regulatory processes, annual reports including DSUR, scientific advice procedures, safety risk management plans, BD managers during due diligence processes, and market access related to clinical development.
* Supervise clinical trial related activities delegated to /shared with Clinical Project Manager including managing study timelines and budget

Required Qualifications and Skills

Education/Training:

* MD, PhD, PharmD or equivalent degree preferably in rheumatology or similar health science discipline
* Clinical Research and GCP training. Clinical Project Management training, a plus

Previous Experience:

* At least 8 years of clinical research and clinical development experience required, and at least 2 years of study management experience working with all drug/medical device development phases, preferred.
* Experience in rheumatology, immunology, or transplant clinical studies, preferred.
* Clinical Research Organization (CRO) or Sponsor Study Management, preferred

Abilities and Skills:

* Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trial(s)
* Working knowledge of GCP, clinical trial design, statistics, and regulatory processes
* Understanding of scientific methods and tools used in early clinical development, biomarkers, translational modeling, biostatistics, and relevant clinical trial landscape
* Strong communication skills with the ability to work in a cross-functional and global organization, required
* Highly organized and able to work within international environments with team members located in different locations/countries. Alignment with our Parent Company's group philosophy to contribute to life and living for people around the world through its group values and group vision
* Able to seek and understand different perspectives, developing alternative solutions and valuing options suggested by others within the team
* Able to understand and clarify boundaries of responsibility within own role and be able to allocate decision-making authority and task responsibilities to other team members as appropriate
* Able to efficiently manage all tasks required during a study, to track multiple items, and provide guidance on the prioritization of tasks within a study

Travel Requirements: Approximately 25 %

#LI-AS1

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.

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