Associate Director, Clinical Pharmacology

Associate Director, & Sr. Project Manager-Clinical Pharmacology JOB PROFILE Ascentage Pharma – Who we are: Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855 ) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Ascentage Pharma is proud of its collaborative and supportive culture, unified by a shared 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 that it succeeds in advancing its mission only as each experience’s success in their role. Following our recent IPO on NASDAQ, we are expanding our U.S. leadership team to support financial compliance, reporting rigor, and scalable growth in a fast paced, complex, multinational environment. The Opportunity Ascentage Pharma is a global, clinical-stage biotechnology company committed to developing next-generation therapies for unmet needs in oncology. We are seeking a strategic and technical leader to join our Clinical Pharmacology team. In this role, you will bridge the gap between preclinical discovery and clinical success. You will serve as the primary Clinical Pharmacology lead for key oncology programs, designing the strategies that define our drug candidates' PK/PD profiles and driving them through global regulatory approvals. What You’ll Do Strategic Leadership: Act as the Clinical Pharmacology and DMPK subject matter expert (SME) on multidisciplinary program teams, translating complex data into actionable development plans. Clinical Design & Execution: Lead the design and oversight of Phase I-III clinical pharmacology studies. You will be responsible for everything from initial gap analysis to study protocols and final Clinical Study Reports (CSR). Quantitative Excellence: Develop and implement modeling and simulation strategies (PopPK, E-R, mechanistic PK/PD) to optimize dose selection and evaluate risk/benefit profiles. Regulatory Impact: Author high-quality Clinical Pharmacology sections for global regulatory filings (INDs, CTAs, NDAs/BLAs) and lead technical interactions with agencies like the FDA and EMA. External & Internal Collaboration: Manage relationships with CROs and external consultants to ensure high-quality, timely delivery of outsourced activities. Mentorship: Provide technical guidance and career coaching to junior scientists, fostering a culture of scientific curiosity and excellence. Who You Are Education: Ph.D. in Clinical Pharmacology, Pharmacometrics, DMPK, or a related pharmaceutical science. Experience: 3+ years (Sr. PM) or 5+ years (Assoc. Director) of industry experience ( preferred) in clinical pharmacology or DMPK. Technical Proficiency: Strong grasp of PK/PD modeling; hands-on experience with population PK and exposure-response analysis is preferred. Regulatory Savvy: Familiar with GCP, ICH guidelines, and global regulatory requirements. Experience in direct FDA/health authority interactions is a significant plus. Communication: An articulate communicator who can simplify complex pharmacological data for diverse stakeholders and lead through influence in a fast-paced, cross-functional environment. Oncology Expertise: Direct experience with Phase I–III oncology trials and a deep understanding of the unique challenges in cancer drug development is a plus. Why Join Us- Our Value Proposition This is a rare opportunity to shape the clinical vision of a public biotech at a pivotal growth moment—and see your work make a tangible impact for patients. If you want to do something that matters—this work matters. Patients drive our passion to pioneer novel cancer therapies. Creating and delivering life-changing medicines requires focus, dedication, and heart. We hire exceptional people, trust them to do their best work, and support them with the resources and flexibility to thrive. What We Offer Exciting, supportive, and intellectually challenging global work environment. Competitive benefits, including medical, dental, vision, disability, and life insurance, parental leave, and a matching 401(k) program (immediate vesting). Generous PTO and holidays encourage balance and recharge. A culture of engagement, diversity, inclusion, and empowerment. Flexibility to work onsite, remotely, or in a hybrid model. Compensation and Benefits At Ascentage, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity, and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity.