Senior Manager, Internal Medicine, Clinical Scientist (Immune/Inflammatory)

Senior Manager, Internal Medicine, Clinical Scientist

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) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

A typical day as a Senior Manager in Clinical Sciences may include:

• 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

This role may be for you if:

• 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 & medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements
• Considerable organizational awareness, including significant experience working cross-functionally

To be considered for this role, you must have a BS/MS/PhD/PharmD in a related field. Additionally, ≥ 8 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. We are seeking experience in one or more of the following therapeutic areas – Immune/Inflammatory related clinical trials.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.