Senior Director, Clinical Development - Oncology - SK Life Science Labs

Working closely with the Early Development Lead, the Senior/Executive Director of Clinical Development Oncology will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs (SKLSL) with a dotted line into its sister company, SK Life Science Inc. (SKLSI). This role will provide strategic leadership across both preclinical and clinical development, ensuring seamless translation of discovery and preclinical findings into early- and late-stage clinical programs, with a particular focus on oncology.

The incumbent will provide therapeutic and translational expertise to the development of the current TPD asset(s), while also contributing to portfolio and pipeline strategy. The role includes close partnership with discovery, preclinical, translational, CMC, regulatory, and clinical operations teams to enable efficient progression from IND-enabling activities through clinical proof-of-concept. The position reports to the Chief Scientific Officer of SK Life Science Labs with a dotted line to the Chief Medical Officer of SK Life Science Inc.

Preclinical and Translational Development

• Provide clinical and translational leadership to preclinical oncology programs
• Partner closely with discovery and preclinical teams to ensure alignment between biological rationale, nonclinical data packages, and clinical development plans
• Contribute to the design, interpretation, and integration of:
• In vitro and in vivo efficacy models
• PK/PD and biomarker strategies
• Translational endpoints to support dose selection and first-in-human studies
• Provide medical and scientific input into IND-enabling studies, including toxicology, safety pharmacology, and reproductive toxicology
• Support development of translational and biomarker strategies to enable early signal detection and patient selection in oncology trials
• Participate in portfolio and pipeline discussions, including evaluation of new oncology targets or assets from a clinical and translational perspective

Clinical Development

• Participate in the development of integrated product development plans and clinical trial strategies informed by preclinical and translational data
• Lead the design and conduct of clinical trials and, as a member of the internal SK Life Science Inc. Clinical Development/Medical Affairs team, provide operational oversight by collaborating with internal and external operations personnel
• Provide medical expertise regarding product development or other scientific issues for drug discovery, development, and senior management decision-making
• Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
• Participate in pharmacovigilance activities, including SAE evaluation, safety signal assessment, and ongoing analysis of safety data
• Participate in preparation and review of protocols, Investigator Brochures, clinical study reports, safety reports, and clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts
• Interface with regulatory agencies for clinical development programs and regulatory submissions as needed
• Oversee scientific interactions with medical consultants, advisors, and clinical investigators
• Establish and maintain strong relationships with clinical investigators and key opinion leaders, fostering enthusiasm and engagement for SKLSL programs

General

• Training in and adherence to Good Clinical Practices (GCP); working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development
• Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development
• Experience interacting with FDA and other global health authorities preferred
• Reports to the Chief Scientific Officer

Skills

• Evidence of ability to work with opinion leaders
• Must be able to work effectively in a team setting
• Communication skills necessary to:
• Represent the Company externally in scientific presentations, conferences and industry groups;
• Present to internal stakeholders; Interact with industry

• M.D. degree with specialized training in oncology preferred
• Practice experience preferable but not required
• Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience
• Ability to multitask
• Adapts to change
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communications
• Adapts change, adjust change and grasps information quickly
• Examine and observe details