Director, Program Operations Leader, Early Clinical Trial Development

Initial Therapeutics, Inc.; Armonk (NY); Hybrid; USD 198,000 - 330,000; Full time

Job summary

An established industry player is seeking a Program Operations Leader to drive the operational strategy for complex clinical programs. This role involves leading clinical trial management activities, ensuring compliance with regulations, and managing budgets and timelines. The ideal candidate will possess advanced leadership and interpersonal skills, a strong analytical mindset, and a proven track record in the pharmaceutical industry. Join a diverse and inclusive culture that values your contributions and offers comprehensive benefits, including wellness programs and equity awards.

Benefits

Health and Wellness Programs

Fitness Centers

Equity Awards

Annual Bonuses

Paid Time Off

Qualifications

• 12 years of experience in the pharmaceutical industry, including 8 years in Clinical Trial Management.
• Experience with early phase clinical trials is highly preferred.

Responsibilities

• Lead and implement operational strategy for clinical programs.
• Manage clinical trial management staff and oversee budget and timelines.
• Coordinate clinical study timelines and provide operational insights.

Skills

Interpersonal Skills

Leadership Skills

Analytical Skills

Budget Management

Project Management

Education

Bachelor's Degree

Job description

For US locations, this role is on-site 4 days per week and 1 day from home. Remote work is not an option for this role.

The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence.

In a typical day, you will:

• Be responsible for the overall success of the clinical study team(s) within a program(s)
• Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to partners as requested
• Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Coordinates clinical study timelines within a clinical program(s)
• Provides input and operational insight into Clinical Study Concepts (CSC)
• Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
• Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of standard processes within CTM
• Leads all aspects of clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate

This job may be for you if you have:

• Advanced interpersonal & leadership skills
• Ability to provide operational strategic direction and guidance for clinical programs
• Applies sophisticated technical knowledge to solve highly complex issues
• An understanding of relevant industry trends
• Strong analytical skills with a data driven approach to planning, executing, and problem solving
• Advanced interpersonal skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads)
• Budget management expertise and strong financial competence
• Consistent track record of building, leading and developing productive teams and collaborations
• Expert project management skills, cross-functional engagement and organizational skills

To be considered, you must have a Bachelor's degree and minimum of 12 years relevant pharmaceutical industry experience, 8 years within Clinical Trial Management. Experience with early phase clinical trials is highly preferred.

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

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)

$198,000.00 - $330,000.00