Associate Director, Site Enablement - Oncology Delivery Unit

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

2d•$137,000 - $235,750•Remote

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Delivery Unit - Oncology. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Associate Director, Site Enablement - Oncology Delivery Unit (DU) will be accountable for accountable for the operational management and successful country execution of all phases of clinical trials within the assigned therapeutic area(s),or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Associate Director will support the Country Head in shaping and managing local organizational structure to ensure its optimal efficiency. This individual will be responsible for line management of Local Trial Managers (LTMs), Site Managers (SMs), Clinical Trial Assistants (CTA) and/or other DU staff (including Manager, Clinical Operations), as required. May also mentor less experienced Functional Managers (FM)/Clinical Research Managers (CRM) and assume cross border oversight, if required. Oversee staff performance, development, training, project assignments, workload distribution and support issue resolution with direct reports. Ensure alignment of local goals with organizational objectives. Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/Global Development (GD) overall.

Requirements

A minimum of a Bachelor's degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
A minimum of 8 years of clinical research experience within the pharmaceutical industry, Contract Research Organization (CRO) and/or investigational site is required.
A minimum of 2 years of line management experience is required.
Experience in the Oncology (Solid Tumor and/or Hematology) Therapeutic Area is required.
Knowledge of the drug development process, clinical research operations and regulatory requirements, including ICH-GCP, Health Care Compliance (HCC) and applicable regulations, is required.
Financial management skills (e.g., budgeting, forecasting, risk analysis, etc.) required.
Must have excellent communication, interpersonal and leadership skills, with the proven ability to foster team productivity and cohesiveness.
Must have strong decision-making, issue resolution and negotiating skills.
Must have flexibility to work in a fast-changing environment and operate under limited supervision.
The ability to evaluate data generated from various reports and sources is required.
The ability to effectively communicate with various internal and external stakeholders (e.g., investigational sites, ethics committees, health authorities, etc.) is required.
The ability to collaborate with all levels of management and handle multiple priorities within a matrix environment is required.
This position will require up to 10% travel.

Nice To Haves

Experience managing a medium (5-9) to large (10+) size team of direct reports is preferred.
Experience managing and executing clinical trials is preferred.

Responsibilities

Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
Evaluate and forecast resource needs for assigned portfolio and/or other specific areas of responsibility, as required and agreed with local DU management accordingly.
Deployment of the One Delivery Model through collaboration and oversight of vendors.
Accountable for the acquisition of new talents and development of human resources.
Guide direct reports in issue resolution and communication with involved stakeholders.
Lead organizational changes and effectively communicate on priority shifts as required.
Review and approve expenses in compliance with the company policies.
Demonstrate leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives.
Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
Define, execute or support long-term strategy in alignment with DU, GD and Johnson & Johnson Innovative Medicine (JJIM) R&D strategies to position the local and global DU organization for success.
Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other areas of responsibility, as required.
Accountable for ensuring relevant operational objectives are met in conformance to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
Contribute to Corrective and Preventative Action (CAPA) and issue resolution in accordance with required timelines.
Shape and maintain strong relationships within local DU department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other areas of responsibility, as required.
Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
Review operational and quality metrics regularly and drive follow-up actions as appropriate.
Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/GD overall.
Foster a culture of continuous improvement and innovation within the local DU team.
Model Credo based culture within the local DU team.

Benefits

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.
Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
Vacation - 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year
Holiday pay, including Floating Holidays - 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours