Executive Director, Clinical Development- Oncology

Overview

The Executive Director of Clinical Development Oncology will lead the radiopharmaceutical (RPT) project for SKLSI. He-she will provide therapeutic and pharmacovigilance expertise to the clinical development of the SKLSI pipeline of therapeutic drugs with particular focus on oncology. He/she will also provide clinical operational support to each product development projects. The Executive Director will work with regulatory affairs, discovery, business development, legal, quality and CMC to facilitate the development of SK Life Sciences products. The position will report to the Chief Medical Officer of SK Life Science.

Responsibilities

General

• Training in Good Clinical Practices (GCP)
• Knowledge of relevant regulatory guidance for the clinical development process
• Experience with FDA preferred
• Reports to Chief Medical 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

Responsibilities:

• Participate in the development of product development plans and clinical trial strategy
• Participate in the design and conduct of clinical trials and as a member of the Clinical Development/Medical Affairs provide operational oversight by collaborating with internal and external operations personnel
• Provide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior management
• Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
• Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data
• Participate in preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the 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 when necessary
• Oversee the scientific interaction with relevant medical consultants/advisor s and investigators

Qualifications

• 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
• Experience with orphan indications, radiopharmaceuticals, or immunotherapy for oncology preferred
• 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
• Travel up to 20%