Senior Manager, Internal Medicine, Clinical Scientist (Cardio, Metabolic, & Renal)

Role Summary

The Senior Manager, Internal Medicine, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Sr. Manager reports to the Associate Director/Director, Clinical Sciences and collaborates closely with Medical Director(s) to provide scientific expertise necessary 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: ≥ 8 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience
• Preferred: Experience in cardiovascular, renal, or metabolic disease

Skills

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

Education

• BS/MS/PhD/PharmD in a related field