Senior Manager, Internal Medicine, Clinical Scientist (Ophthalmology)

Role Summary

The Senior Manager, Internal Medicine, Clinical Scientist leads the development, evaluation, planning, and execution of clinical studies and ensures the integrity and interpretation of study data within a clinical development program. Works in a matrix, cross-functional environment and may contribute to candidate development across early and late phase programs. Reports to the Associate Director/Director, Clinical Sciences and collaborates closely with Medical Directors to provide scientific expertise to design and deliver on clinical studies and programs.

Responsibilities

• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam
• Develops/maintains understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late stage assets; Assists with development of the Expanded Synopsis and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments
• Assists with and may author/review documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and may support the development of regulatory documents; may perform quality review
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
• Collaborates with internal functions and external vendors to promote clinical study integrity
• Exhibits strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supports identification and/or identifies critical risks and mitigations
• Promotes consistent first line medical/clinical data review techniques and conventions across assigned studies; Reviews clinical data review plan and medical monitoring plan for assigned studies

Qualifications

• Required: BS/MS/PhD/PharmD in a related field
• Required: ≥ 8 years of pharmaceutical clinical drug development experience
• Required: Experience in Ophthalmology clinical trials
• Preferred: Other levels considered depending on experience

Skills

• Demonstrated ability to influence within team and may influence cross functionally
• Exhibit strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills
• Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways
• Strong management, interpersonal and problem-solving skills
• Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology and medical writing skills; knowledge of clinical development processes, regulatory requirements and ICH/GCP guidelines; proven track record in clinical trial process improvements
• Considerable organizational awareness, including significant experience working cross-functionally

Education

• BS/MS/PhD/PharmD in a related field