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Associate Director, Clinical Scientist, Oncology - Basking Ridge, NJ, United States - Regeneron Pharmaceuticals, Inc
Description
We are seeking a Associate Director to join out Oncology Clinical Development department.The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program.
The Associate Director 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 Associate Director reports to the 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.
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; Member of the Clinical Study Team and Global Clinical SubTeamMaintains proficient 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 as well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
Identifies opportunities for process improvements.
Resolves novel problems requiring creative application of advanced skill, training, and education
May serve as a peer coach learning how to mentor and provides guidance to junior members of department and cross-functional team members as appropriate
To be considered for this role, you must have a Bachelor's Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) is preferred.
≥ 10 years of pharmaceutical clinical drug development experience.We are seeking proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs.
Strong cross-functional management, interpersonal and problem-solving skills. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. The salary ranges provided are shown in accordance with U.
