Associate Director Precision Medicine Clinical Laboratory Operations

Initial Therapeutics, Inc.; Armonk (NY); On-site; USD 154,800 - 252,800; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Job summary

An established industry player is looking for an Associate Director in Precision Medicine Clinical Laboratory Operations. This pivotal role involves overseeing clinical laboratory project management across various therapeutic areas, ensuring timely study starts and effective risk management. The ideal candidate will leverage their extensive experience in clinical trials and laboratory operations to collaborate with cross-functional teams, driving successful outcomes in early and late-stage programs. With a focus on strategic oversight and stakeholder collaboration, this position offers a unique opportunity to impact innovative research initiatives in a dynamic environment. If you're a proactive leader with a strong background in clinical operations, this role is your chance to shine.

Qualifications

• 10+ years of pharmaceutical experience in matrix interaction.
• 5+ years experience with Clinical Trials and clinical sample collection.

Responsibilities

• Manage clinical laboratory project timelines and risks.
• Collaborate with cross-functional teams for clinical deliverables.

Skills

Leadership

Project Management

Clinical Trials

Risk Management

Collaboration

Education

Bachelor's Degree

Tools

Clinical Laboratory Management

Biospecimen Logistics

Job description

The Associate Director, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to provide strategic oversight of laboratory deliverables across the portfolio, ensuring that study start timelines are met, provide risk management and collaborate with stakeholders for all aspects of clinical laboratory deliverables (from study conduct, sample management testing to launch). This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.

As an Associate Director, a typical day may include the following:

1. Perform strategic and clinical laboratory portfolio management for Regeneron clinical trials.

2. Review clinical laboratory operations timelines and risks and be able to manage and communicate risks and ensure study starts and data delivery are aligned with expectations.

3. Be a subject matter expert on central and specialty laboratory processes and leverage this knowledge to be a trusted stakeholder and ensure clinical laboratory deliverables.

4. Work closely with stakeholders including Precision Medicine Strategy Leads and Clinical Laboratory Strategy Management team, to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies, identifying and tracking risks and decisions, creating mitigation plans.

5. Inform and shape clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines.

6. Develop strong relationships and trust with internal and cross-functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads and others within Global Development to manage and implement program level clinical laboratory management.

7. Oversee operational aspects of clinical trial laboratory implementation and communicate effectively both externally and internally. Where needed, identify solutions for barriers to success in the clinical laboratory space.

8. Demonstrate relevant knowledge and understanding of clinical laboratory trial requirements on the program and execute strategic operational decisions. Ensure the laboratory portion of the studies are harmonized for assigned program from onset to final delivery.

9. Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction. Demonstrate authority for the studies related to the program. Established as a leader for the program and can dive into the details when required, with attention to detail.

10. Bridge laboratory clinical trial operations work through research teams and tech centers at Regeneron, managing timelines for the lab delivery in clinical trials and other human sample projects to ensure seamless execution and adherence to project deadlines.

11. Provide subject matter expertise on human sample management projects, including acquiring samples from outside sources and executing new project ideas to support innovative research initiatives.

12. Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment, design and develop processes to address identified gaps.

13. Lead and facilitate decision-making forums for clinical lab strategy within the portfolio, while identifying and adjusting new processes as required with forward-thinking, big-picture skill sets.

This role may be for you if:

1. You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment.

2. You demonstrate strong leadership skills and possess a high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success.

To be considered for this role, you must have a Bachelors degree and a minimum of 10 years pharmaceutical experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams. Minimum of 5 years experience with Clinical Trials, focus on clinical sample collection. Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested. We need a strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required. We are seeking clinical study knowledge, demonstrated by knowledge in science and technology.

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.

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)

$154,800.00 - $252,800.00