Director, Early Development, Global Clinical Operations

Johnson & Johnson; North Carolina; On-site; USD 160,000 - 276,000; Full time

Job summary

A leading healthcare company is seeking a Director of Early Development in Global Clinical Operations to manage and direct clinical trials. This role includes oversight of resources, budget, and compliance with regulatory standards while driving team development and fostering strong relationships across various departments. Ideal candidates will bring over 10 years of experience in the pharmaceutical sector and a proven record in leadership and project management.

Benefits

Medical, dental, and vision insurance

401(k) retirement plan

Vacation - up to 120 hours per calendar year

Annual performance bonus

Qualifications

• Bachelor's degree or equivalent required; advanced degree preferred.
• Minimum of 10 years’ experience in the pharmaceutical industry.
• Excellent communication and leadership skills.

Responsibilities

• Define the GCO ED strategy for the region.
• Accountability for planning and execution of clinical trials.
• Manage and develop GCO ED team.

Skills

Leadership

Communication

Project Management

Financial Management

Regulatory Knowledge

Education

Bachelor's degree in Life Sciences

Master’s degree in a scientific discipline

Tools

MS Office

Job description

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:

Enterprise Management

Job Sub Function:

R&D Management

Job Category:

People Leader

All Job Posting Locations:

La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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 Director, Early Development, Global Clinical Operations to be located in Spring House, PA; Titusville, Raritan, NJ or La Jolla, CA.

Purpose: The Director Early Development (ED), Global Clinical Operations (GCO) is accountable for defining the strategy and operational management of trial coordination and site management activities of the GCO ED team in the countries within the region. The candidate will ensure the successful country and regional execution of early development and clinical pharmacology (ED&CP) trials, including resource allocation, adherence to timelines and budget, compliance with all GCO SOPs, policies and regulatory requirements.

The candidate is responsible for the line management and the development of their staff, e.g.

Functional Managers (FM), Trial Managers (TM), Site Managers (SM), Site Strategy Leads (SSL), Clinical Trials Assistants (CTA) and any other GCO ED&CP staff in their reporting line.

The candidate supports Human Resources development programs which include Performance and Development management, talent management and training requirements. The candidate ensures alignment of goals with organizational and assigned trial objectives.

For countries where the staff involved in early development and clinical pharmacology trials do not report into the Director Early Development, the accountability for delivery of early development and clinical pharmacology trials is shared with the respective GCO country heads. For these countries the Director Early Development is responsible for ensuring that these countries fulfill the criteria needed for conducting early development and clinical pharmacology trials and has oversight responsibilities for the conduct and delivery of these trials.

As member of the GCO Early Development Community of Practice and GCO Regional Leadership Team, he/she will be responsible for contributing to the development of the GCO ED strategy, contribute to overall GCO strategy, develop capabilities and implementation of innovative creative solutions.

Reports to the VP GCO for the Region.

You will be responsible for:

• Define the GCO ED strategy for the region, aligned with GCO and R&D strategies, to set up the GCO ED team for success.
• Overall accountability for the planning, preparation, execution and close out of early development and clinical pharmacology clinical trials in the region.
• Ensures all operational objectives are met in compliance with all relevant ICH-GCP regulations, guidelines including Health Care Compliance, internal SOPs, Work Instructions, and Policies.
• Appropriate and timely escalation of issues to GCO leadership. Report (suspicion) of fraud or scientific/ethical misconduct.
• Ensures that GCO ED Functional Managers have proper connectivity with the local Health Authority agencies for activities related to GCO early development and clinical pharmacology trials.
• Authorized representative to sign contracts, agreements, and PO’s.
• Accountable for local and/or regional annual budget process in compliance with financial processes (i.e., reporting) and responsible for maintenance of the Affiliate Funding contract.
• Member of GCO Regional Leadership Team.
• Build strong relationships with regional/local GCO Heads, Regional/local Q&C Managers, GCO ED Functional Managers, GCO Business Operations, Site Strategy Lead, Delivery
• Units, Bio-research Quality & Compliance (BRQC), Integrated Data Analytics and Reporting (iDAR), Clinical Supplies Unit (CSU), R&D Procurement (JRP) (including Contract & Grants), Medical Affairs and other internal/external business partners as required).
• Contributes to shaping an attractive clinical trials environment through active involvement with Pharma Industry Associations, Medicines Agencies, Health Authorities in countries where early development and/or clinical pharmacology trials are conducted.
• Collaborates with the on-country capabilities and study placement. Oversees or sets study feasibility strategy for the region.
• Ensures the site selection processes are in alignment with business and country strategic goals.
• Leads GCO ED quality and productivity metrics review for the region and ensures documentation of remediation plans in the Quarterly Quality Review (QQR) Report and oversees the implementation of the remediation plans.
• Leads and/or contributes to the design, development and evaluation of the Clinical
• Operations processes and standards to improve clinical trial management. Ensures rollout of new procedures.

Duties & Responsibilities related to country oversight

Oversight responsibilities for countries where staff involved in early development and clinical pharmacology trials do not report into the Director Early Development

• Act or delegate a Primary point of contact (PPOC) for country heads/functional managers and for ED-TDLs for early development and clinical pharmacology trials in the region.
• Ensure staff assigned to early development and clinical pharmacology trials are adequately trained on the ED operating model.
• Ensure feasibility assessment, site selection and recruitment plans are aligned with GCO ED requirements and strategy.
• Provide guidance on process for conducting and documenting site assessments and sign off reports.
• Review productivity and quality metrics and ensures documentation of remediation plans in the QQR Report and oversees the implementation of the remediation plans.
• Follow up on general issues escalated by the ED-TDL/PDL.
• Ensures Accompanied Site Visits are planned and conducted for all SMs assigned to early development and clinical pharmacology trials.

Functional Management Responsibilities

• Evaluates and projects overall resource needs for GCO ED in region, and requests resources as appropriate.
• Strong interaction with Flex Resource managers to ensure qualified staff is assigned in timely manner, and to provide feedback on Flex Resource performance. Works with Flex Resource managers to on-board and off-board staff.
• Interviews, hires, develops, and trains staff.
• For employees: Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment.
• Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company policies supported by documentation in training compliance systems.
• Communicates with staff on program changes, policy changes and priority shifts.
• Oversees staff involved in local Health Authority site inspections and follow-up activities including CAPA generation.
• Review and approve expenses; assure expenses in compliance with the company’s policies. 9 Strongly demonstrates Leadership Behaviors in alignment with Leadership Imperatives.

• Fosters an environment that encourages the sharing of ideas, information, and best practices (internal and external to the organization).
• Provides mentorship as needed (outside of direct reports).

Principal Relationships:

Reports to VP GCO of the region.

Primary interfaces: GCO ED Functional Managers, Site Strategy Leads, GCO Regional VP, GCO Business Operations, ED PDLs, GCO late development country heads, Regional/local Q&C Managers.

Other Internal Interfaces: Delivery Units, Bio-reseach Quality & Compliance (BRQC),

Integrated Data Analytics and Reporting (iDAR), Clinical Supplies Unit (CSU), Janssen R&D Procurement (JRP) (including Contract & Grants), Medical Affairs and other internal/external business partners as required).

External Interfaces: CRO Functional Management, Flex staff providers, Health Authorities, Local Pharma Industry Associations, Investigational Sites and others.

Qualifications

Education:

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Master’s degree is preferred.

Experience/Skills:

• Minimum of 10 years’ experience in the pharmaceutical industry, at a CRO or hospital including extensive clinical research experience (experience in early development preferred).
• Experience in working within the applicable geographical area is preferred.
• Excellent communication and leadership skills and proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. A proven track record of people and project management. Strong in hiring, training, development and evaluation of leaders and people managers. Strong decision-making and financial management skills and the innate flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Demonstrated experience in transitioning an organization into high performance organization in response to business needs.
• Leading in issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations / FDA CFRs (if applicable).
• Strong ability to synthesize and evaluate data generated from various reports and sources.
• Demonstrated skills in interfacing with various internal and external (e.g. hospital boards, agencies, ethics committees, health authorities, etc.) stakeholders. Experience working with CRO partnerships is required. Influential in improving the clinical research environment at country level. Visionary Leader who can influence organizational culture to improve adoption of future state.
• Operates with limited supervision.
• Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

The expected pay range for this position is $160,000 to $276,000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on June 25, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

$160,000-$276,000

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.