Manager Clinical Sciences – Internal Medicine

Manager Clinical Sciences – Internal Medicine

Requirements

• Minimum of Bachelor’s Degree required
• Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
• Minimum of 3 years of pharmaceutical clinical drug development experience
• Basic knowledge of oncology or hematology therapeutic areas
• Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines

Responsibilities

• Member of the Clinical Study Team and Global Clinical sub-team
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies
• Assists with development of the Expanded Synopsis and may author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
• Assists with and may authors/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Contributes to preparations for external/stakeholder meetings and presents data and information to external investigators and internal collaborators

Preferred Qualifications

• Demonstrated knowledge of the drug development process
• Good Clinical Practice
• Study design and clinical research methodology
• Solid medical writing skills
• Proven ability to influence within team and across functionally
• Exhibit strong analytical and influencing skills
• Ability to communicate concise and clear messages
• Strong presentation skills