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SK Life Science, Inc. · 1 day ago

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

Full-time

Onsite

Director/Executive

10+ years exp

SK Life Science, Inc. is seeking a Senior Director of Clinical Development in Oncology to lead clinical execution of targeted protein degradation projects. This role involves strategic leadership across preclinical and clinical development, ensuring the translation of discovery findings into clinical programs with a focus on oncology.

BiotechnologyPharmaceutical

Responsibilities

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

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

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

Qualification

Clinical DevelopmentOncology ExpertiseTranslational DevelopmentRegulatory KnowledgeMedical MonitoringDetail OrientationCommunication SkillsTeam CollaborationAdaptability

Required

M.D. degree with specialized training in oncology preferred

Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience

Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development

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

Communication skills necessary to present to internal stakeholders

Communication skills necessary to interact with industry

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