Manager Global Clinical Supply Chain

Ascentage Pharma: (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. Ascentage Pharma is proud of its collaborative, supportive culture, unified by the desire to develop therapeutics that will have a positive impact on patients’ lives. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history. The company is defined by a shared understanding it succeeds in advancing its mission only as each individual experiences’ success in their role.

Leveraging our robust internal research and development capabilities, we have built a portfolio of global intellectual property rights. We have also established global collaboration relationships with leading biotechnology and pharmaceutical companies, such as AstraZeneca, Innovent, Merck, and Pfizer, and research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan. We are a leader in global innovation with a portfolio of more than U.S. and international patents and more than U.S. and international pending applications.

We have assembled a talented, global team with experience in the research and development of innovative drugs, as well as commercial manufacturing, sales and marketing. Our success is shaped by this global team of close to 600 employees across United States, Europe, Australia, and China.

Manager of Global Clinical Supplies

The Manager of Global Clinical Supplies (GCS) is a key role within our Clinical Program Management team and is responsible for supporting all matters pertaining to the global forecasting and planning of investigational materials for clinical studies with a primary responsibility for creating and maintaining the execution of investigation material supply strategies for global studies.

Role and Responsibilities

• Proactively support the oversight and management of supply strategies for all investigational material based on study needs.
• Supports the management of investigational products by monitoring and managing clinical supply inventories.
• Proactively drive the labeling, packaging, release, distribution of clinical supplies for assigned studies, ensuring the project timelines are met or exceeded.
• Provide support to study teams for distribution queries, IRT support, returns, and destructions.
• Participate in process improvement initiatives resulting in cohesive supply chain activities
• Represent clinical supplies function at clinical trial team meetings and communicate plans and timelines to relevant parties.
• Foster strong collaboration with all functional partners, including but not limited to Product Development & Production, Supply Chain Management Group, CMC, Clinical Operations, External Vendors, Clinical Medical Management, Regulatory Affairs and others as needed, to assure clinical trials are conducted efficiently and effectively solve abstract problems across functional area of the business
• Collaborates with internal GCS teams and external Customers and service providers including but not limited CMC Supply, CMC Product Development, and Regulatory.
• Ensure appropriate documentation is filed appropriately to the TMF and supports company efforts for inspection readiness.
• Performs other tasks as assigned

Qualifications and Education Requirements Preference for Candidates in the DVM.

• BA/BS in Lifesciences, 5 yrs. Experience in the pharmaceutical industry with at least 3 yrs. experience in drug development, clinical supply chain management, and/or clinical manufacturing or equivalent experience.
• Experience across multiple functional areas (i.e., clinical, regulatory, quality) demonstrating a broad understanding of pharmaceutical development.
• In-depth knowledge of all phases of drug development, the functions and processes relevant to drug development, and general project management principles applicable to the biopharmaceutical environment.
• Experience with planning and execution of investigational materials supply strategies
• Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders.
• Experience managing change in a dynamic, complex environment.
• Strong background in cGxPs and ICH requirements.

Preferred Skills

Computer skills with competency in Microsoft Office suite. Knowledgeable of eClinical systems such as IRT (IVRS/IWRS/RTSM), CTMS, EDC, electronic eTMF.

Culture

At Ascentage Pharma, we strive to create a culture based on personal and professional growth and opportunity, focusing on these principles to establish a collaborative, energized work environment where people are empowered and supported in achieving their career goals; Create a diverse and multi-disciplinary workforce at all levels with resolute, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, with a shared commitment to science and to the patients we serve.

Compensation and Benefits

Ascentage Pharma offers an extremely competitive compensation package, including an annual bonus along with:

• Exceptional, Medical, Dental, and Vision plans for employees and families.
• Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance
• 401K with an immediate and generous company match
• Liberal paid time off
• Flexible schedules for staff and employee assistance program

Ascentage Pharma is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is Ascentage Pharma's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, marital status, status as a protected veteran, or any other legally protected group status.