Functional Manager GCO ED&CP
Johnson & Johnson
Tilburg, Netherlands
6 dagen geleden

Job Description

Position Title : Functional Manager GCO ED&CP

Location : Netherlands, Tilburg

Position Summary :

The Early Development & Clinical Pharmacology (ED&CP) Functional Manager I (FM I) is accountable for strategic and operational management and successful country execution of early development and clinical pharmacology (phase 0-IIa) trials across multiple therapeutic areas, including resource allocation, adherence to timelines and budget, compliance with relevant SOPs, policies, Health Care Compliance and local regulatory requirements.

The ED&CP FM I will be shaping and managing local organizational ED&CP structure to ensure its optimal efficiency and demonstrates an effective issue management.

This individual has line management responsibility for Trial Managers (TMs), Site Managers (SMs), Clinical Trial Assistants (CTAs) and / or other GCO staff as the need arises.

Coordinates staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports.

Ensures alignment of local goals with organizational objectives.

Drives innovative solutions and process improvements for ED&CP organization and GCO / GD overall.

Principal 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 area of responsibility, as required and agreed with Global Head ED&CP / US head ED&CP accordingly.
  • Support the flexible resourcing model and collaborate with Flex Resource managers to hire qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
  • Interview, hire, develop and train staff.
  • Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance, as required.
  • Support direct reports in issue resolution and communication with different stakeholders like Ethics Committees, Health Authorities, Investigational Sites and study management team.
  • Support local implementation of organizational changes and effectively communicate on priority shifts.
  • Review and approve expenses in compliance with the company policies.
  • Demonstrate leadership behaviours in alignment with J&J 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 and execute long term strategy in alignment with GD, ED&CP organization and Janssen R&D strategies to position the local and global ED&CP organization for success.
  • Accountable for attracting, planning, execution and monitoring of ED&CP clinical trials (from feasibility to close-out) and ensuring inspection-readiness for assigned portfolio and / or other area of responsibility as required.
  • Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
  • Accountable for appropriate and timely issue escalation and reporting of (suspicion) of fraud, scientific / ethical misconduct and health care compliance breach.
  • Contribute to CAPA and issue resolution in accordance with required timelines.

  • Shape and maintain strong relationships within ED&CP organization, local GCO department, local R&D head and Local Operating Company and other key internal and external stakeholders
  • Develop country ED&CP capabilities and collaborates with Global Program Leader (GPL) and Regional Therapeutic Area Expert (RTAE) for an effective study placement within the multiple therapeutic area(s) and / or other area of responsibility, as required.
  • Accountable for robust feasibility process and oversight of sites selection to deliver on ED&CP country commitments and strategic goals
  • Lead regular metrics review and drive necessary follow-up actions.
  • Ensure adequate quality oversight and inspection readiness within the different therapeutic area(s) and / or other area of responsibility, as required
  • Oversight of local ED&CP budget and accurate financial reporting in compliance with financial processes.
  • Collaborates with local R&D Head and Late Development FM to implement specific local processes / regulatory requirements applicable for both LD and ED&CP teams.
  • Contribute to development, evaluation and implementation of new processes and systems to improve ED&CP studies management.
  • Foster a culture of continuous improvement and innovation within the local ED&CP team
  • Model Credo based culture within the local ED&CP team
  • Qualifications

    We would love to hear from YOU, if you have :

    Bachelor's degree or equivalent required, preferably in Life Sciences Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

    Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site. ED&CP previous clinical trial experience is preferred.

    Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.

    Experience in mentoring / coaching others (line management experience desirable). Skilled in leading, hiring, training, developing and evaluating people.

    Proven decision-making and financial management skills.

    Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.

    Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.

    Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders investigational sites, ethics committees, health authorities, etc.).

    Flexible mindset and ability to work at a fast paced in a fast-changing environment in different therapeutic areas. Operates under limited supervision.

    Proficient in English language. Computer literacy. 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.

    Are you ready to make an impact?

    If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

    We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing.

    You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

    About Janssen, the Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working diligently to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.

    We focus on areas of medicine where we can make the biggest difference : Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    Ready to be part of something great? Don't forget to apply. We want YOU!

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