We are seeking an Associate Director to join our 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 Directors (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.
As an Associate Director, a typical day may include the following:
- May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
- Contributes to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; may represent function in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam
- Maintains 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; able to conceive and communicate strategy proposals well-grounded in supporting literature.
- 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; adjudicate and resolve cross-functional comments with minimal support
- 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
This role may be for you if:
- Ability to lead activities within a matrix environment; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to Influence within team and may influence across functionally
- Demonstrates initiative, creativity, and innovation skills. Directly or indirectly contributes to the development of innovations; 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. Other levels considered depending on 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Company's business.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$170,100.00 - $277,500.00
