J&J Family of Companies Functional Manager Early Development & Clinical Pharmacology (ED&CP) in Global Clinical Operations (GCO) in Breda, Netherlands

Functional Manager Early Development & Clinical Pharmacology (ED&CP) in Global Clinical Operations (GCO)

Description

Global Clinical Operations is recruiting a Functional Manager GCO ED&CP for Belgium and the Netherlands. In this position, you will be responsible for:

• The direct functional management of a regional team of ED&CP Trial Managers (TMs), Site Managers (SMs) and Clinical Trial Assistants (CTA).

• Setting goals & objectives for direct reports, performance evaluation, coaching/mentoring, overseeing staff training and development, study assignments, workload distribution and accompanied site visits.

• Feasibility assessment for studies considered to be placed in the region and the development of relationships with key investigators.

• Execution of phase 0, I and IIa clinical studies by direct staff from feasibility assessment to database lock according to protocol, SOPs, regulations and adherence to timelines and budget.

• Evaluating and projecting resource needs for your assigned portfolio in collaboration with other ED&CP Functional Managers and Clinical Program Leaders.

• Recruitment of new staff.

• Developing the capabilities in your region for conducting ED&CP trials from different therapeutic areas.

• Maintaining excellent working relationships with various internal and external stakeholders.

• Providing expertise regarding local health care systems and clinical research regulations

• Participating and/or leading global initiatives as well as driving local (country specific) special initiatives as needed and guiding rollout of new process and procedures.

• Participating in clinical research initiatives with stakeholders from outside the company (i.e., Pharmaceutical Chambers, Medical Societies, Advocacy Groups, Regulatory Bodies, etc.).

Qualifications

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

• Minimum of 8 years’ experience in the pharmaceutical industry, at a CRO or hospital including extensive clinical research experience.

• Experience in early development and/or clinical pharmacology clinical research is preferred.

• Proven ability of people management

• Strong communication and leadership skills to foster team productivity, talent development and cohesiveness.

• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.

• Flexible and independent mindset with the ability to lead and implement change.

• Strong ability to synthesize and evaluate data generated from various reports and sources.

• Proficient in English language.

• Strong knowledge of MS Office.

• Location: The Netherlands or Belgium

Primary Location

Belgium-Antwerp-Beerse

Other Locations

Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Clinical Trial Coordination

Requisition ID

1700184217W