Associate Director, Clinical Operations and Trial Support

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Associate Director, Clinical Operations and Trial Support to be located in Spring House, PA.

Purpose:

This position is for a leader of the global clinical operations and trial support team within the Bioanalytical Discovery and Development Sciences (BDDS). The team works with internal bioanalytical groups in the US and Belgium and external partners to ensure the completion of all bioanalytical activities related to clinical study protocols and central lab scope of work (SOW), data deliveries and sample management. The team works to support all therapeutic areas within Johnson & Johnson, spanning nonclinical studies to post-market clinical development.

Lead a team and provide input to operational plans with measurable contribution towards the achievement of short-term department results.

You will be responsible for:

• Manages other Managers, Supervisors, and/or individual contributors in a matrix environment, and is accountable for conducting effective performance management and meaningful career development conversations.
• Contributes to the execution of clinical operational and trial support strategy for an area of bioanalytics, pharmacokinetics, clinical pharmacology and pharmacometrics to meet research objectives and support product development and registration.
• Oversight of team that collaborates cross functionally with internal bioanalytical groups and external partners to ensure the completion of all bioanalytical activities related to clinical study protocols and SOW, data deliveries and sample management.
• Provides support for preclinical or clinical studies that support discovery, clinical candidate selection, development and approval of medicines.
• Review and provide comments on the technical documents (protocols, statement of works and lab manuals) from internal groups, Central Laboratories, and outsourced bioanalytical laboratories for studies where the department conducts analyses, receives results, or has oversight of an external laboratory.
• The team works to ensure data transfer agreements are in place per departmental guidelines.
• Guides clinical development activities in the area of clinical operational and trial support; innovates to improve process efficiency and quality.
• Ensures compliance with company standard operation procedures and other regulatory guidelines.
• Represents J&J at industry conferences and associations.
• Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within established timelines and budgets.
• Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

Qualifications / Requirements:

• Minimum of a bachelor’s degree and 8-10 years of work experience.
• Minimum of 2-4 years of people leadership is preferred.
• Experience managing colleagues in a pharmaceutical or CRO bioanalytical group is required.
• Excellent communication, interpersonal skills, networking skills, a high level of organizational ability, and attention to detail are required.
• Experience reviewing lab-based technical documents (e.g., Protocols, Statements of Work, and/or Lab Manuals) is required.
• Experience working in