Associate Director, Clinical Development

Ascentage Pharma; United States; Hybrid; USD 180,000 - 250,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Ascentage Pharma in the United States seeks an Associate Director, Clinical Development to provide medical and scientific oversight for oncology trials across Phases I–III. You will work with indication leads to shape strategy, ensure safety, and drive study design while collaborating with cross-functional teams and external stakeholders.

Ideal candidates are physician‑scientists with oncology drug development experience, capable of drafting regulatory documents and contributing to submissions.

Qualifications

• MD/DO or international equivalent with completion of an accredited clinical residency.
• Board certification or eligibility in Medical Oncology or Hematology/Oncology strongly preferred.

Responsibilities

• Contribute to clinical development plans and study strategies under senior leadership.
• Support indication-specific strategy through literature reviews and data analysis.
• Draft and review clinical trial documents (protocol concepts, study synopses, protocols, amendments).
• Collaborate cross-functionally for scientific and operational alignment.
• Participate in medical monitoring activities and safety data assessments.
• Prepare regulatory content for submissions (INDs, NDAs, Investigator Brochures, CSRs).

Skills

Clinical development

Oncology

Regulatory

GCP

Cross-functional collaboration

Medical writing

Education

MD/DO or international equivalent

Board certification in Medical Oncology or Hematology/Oncology preferred

Job description

Associate Director, Clinical Development

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.

Position Summary

Associate Director, Clinical Development

The Sr. Manager, Clinical development, provides medical and scientific support for the design, execution, and interpretation of oncology clinical trials across early and late stages (Phase I–III). Working under the guidance of clinical indication leaders, the Associate Medical Director contributes to clinical strategy, ensures scientific integrity, and supports patient safety within assigned programs. This role is ideal for a physician‑scientist with foundational experience in oncology drug development who is eager to grow into broader responsibilities while collaborating across multifunctional teams and external stakeholders

Key Responsibilities

• Contribute to the development and execution of clinical development plans and study strategies under the supervision of senior clinical leadership.
• Support indication‑specific strategy through literature reviews, data analysis, and scientific input into development decisions.
• Assist in drafting and reviewing clinical trial documents, including protocol concepts, study synopses, protocols, amendments, and operational documents.
• Collaborate cross‑functionally to ensure scientific and operational alignment.
• Participate in medical monitoring activities, including patient eligibility reviews, safety data assessments, and ongoing study data evaluation in collaboration with senior medical monitors and pharmacovigilance.
• Contribute to review of study integrity, safety summaries, and internal communication of emerging data.
• Support preparation of clinical content for regulatory submissions (e.g., INDs, NDAs, Investigator Brochures, Clinical Study Reports).
• Participate in regulatory meetings as appropriate and ensure adherence to Good Clinical Practice (GCP) and internal quality standards.
• Assist in analysis and interpretation of clinical trial data, contributing to assessments of safety, efficacy, and clinical relevance.
• Prepare scientific materials for internal presentations, publications, and conference abstracts.
• Support interactions with Key Opinion Leaders (KOLs), clinical investigators, and scientific advisors.
• Represent the clinical development function in cross‑functional teams, contributing medical and scientific insights.
• Collaborate with colleagues in Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Commercial to support study execution and timelines.
• Provide clinical perspectives during feasibility assessments, operational planning, and team discussions.
• Contribute medical insights to translational research plans, biomarker strategies, and exploratory clinical science initiatives.
• Support due diligence and business development activities as needed

Required Qualifications

• Education: Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or internationally recognized equivalent degree, with completion of an accredited clinical residency program. Board certification or eligibility in Medical Oncology or Hematology/Oncology is strongly preferred.
• Experience: A minimum of 2-4 years of clinical research experience in the pharmaceutical or biotechnology industry, academia, or equivalent, specifically within oncology drug development.

This experience must include:

• Exposure to multinational Phase I–III oncology trials.
• Experience contributing to protocol development and clinical study execution.
• Prior involvement in medical monitoring or investigator roles.
• Interaction with regulatory agencies (e.g., FDA) is a plus.

Skills:

• Strong understanding of clinical trial methodology, regulatory principles, and GCP.
• Excellent communication skills (written and verbal).
• Ability to collaborate effectively in cross‑functional teams and contribute to complex problem‑solving.
• Highly organized, with the ability to manage multiple priorities in a fast‑paced environment.
• Demonstrated scientific curiosity and commitment to evidence‑based clinical decision‑making.

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.