Associate Director, Data Management Leader Neu

Festanstellung nicht angegeben n/a Bachelor

Janssen Research & Development, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director, Data Management Leader. This position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Chesterbrook, PA; Beerse, Belgium; Leiden, Netherlands; Breda, Netherlands; High Wycombe, United Kingdom; or Allschwil, Switzerland.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Associate Director, Data Management Leader (DML) within the Integrated Data Analytics and Reporting (IDAR) organization will propose the Data Management strategy of one or more programs of medium to high complexity within a disease area and/or therapeutic area or region. Oversee the planning and execution of all data management activities across multiple clinical trials for the programs/regions assigned. Supervise full-time Global Data Managers (GDM) assigned to their programs and execute associated hiring, onboarding, coaching and performance management responsibilities. Identify assignments for flex staff and assess effectiveness of flex staff as appropriate.

This position will serve as the data management primary point of contact for the Global Program Leader (GPL) and is accountable to the GPL for data management at the program/region level. Escalate data management issues and propose solutions to the Functional Lead (FL), the GPL and IDAR Therapeutic Area Lead (TAL), as needed. The DML may work with the IDAR TAL and other IDAR leads to develop IDAR strategies for a program. Provide leadership and expertise to the department in relevant technical areas and cross-functional initiatives. Provide input and/or leadership into the development of departmental policies, processes, training, and/or standards.

Principal Responsibilities:

  • Accountable for data management strategy, planning, execution of activities of medium to high complexity within one or more programs/regions.
  • Planning, execution and completion of all data management activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned programs/regions.
  • Serve as the data management primary point of contact to the GPL for each assigned trial/program/region. In collaboration with IDAR TAL and TA FL, define the data management strategy, including the choice of external service provider for the assigned programs.
  • Contribute to the development of data management vendor contracts and R&D Company business planning budget estimates.
  • Evaluate resource demand and ensure updates to functional planning systems.
  • Anticipation, prevention and early detection of issues impacting data management deliverables for a program/region. Manage program/region level data management issue resolution activities and escalates to GPL, IDAR TAL, and TA FL as needed.
  • Collaborate with IDAR staff and vendors to monitor work and ensure delivery of milestones that meet pre-defined expectations.
  • Collaborate with internal cross-functional colleagues and external partners to define the data integration strategy for a program as appropriate.
  • Collaborate with external partners on data management related deliverables for co-development programs.
  • Take a leadership role for data management related aspects of regulatory agency inspections and Johnson & Johnson internal audits. Coordinate real time inspection readiness for all data management deliverables, as necessary.
  • Lead the data management team meeting for each program, as needed.
  • Provide leadership by attracting and retaining top talent, developing team members and ensuring organizational effectiveness, transparency and communication.
  • Accountable for performance management, career development and salary administration for direct reports and will make decisions appropriate to this type of oversight and management.
  • Provide supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
  • Provide input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model. Perform interviews and proposes hiring decisions.
  • Ensure staff compliance with department Standard Operating Procedures (SOPs), policies and regulatory guidance documents.
  • Contribute to the development and maintenance of departmental policies, procedures, training and standards.
  • May serve as a process, standard or system owner.

Qualifications

  • A minimum of Bachelor’s degree is required, preferably in a Scientific discipline. Advanced degree (Master’s, PhD is preferred).
  • A minimum of 7 years of relevant data management experience within the Pharmaceutical, Contract Research Organization (CRO) or Biotech industries is required.
  • Knowledge of data management practices (including tools and processes) and relevant regulatory guidelines is required.
  • Knowledge of regulatory guidance documents, such as Good Clinical Practices (GCP)/International Council for Harmonization (ICH) requirements and relevant clinical R&D concepts is required.
  • Therapeutic Area (TA) experience and portfolio knowledge is required.
  • People management experience is required.
  • Experience working on cross-functional teams required.
  • The ability to collaborate with all levels of management and influence decision-making across a matrix environment is required.
  • Project management experience is preferred.
  • Experience with outsourcing strategies preferred.
  • Experience with contract oversight is preferred.
  • Must have excellent verbal and written communication skills.
  • Must have excellent leadership, decision-making and negotiating skills.
  • Must have the ability to foster team productivity and cohesiveness, act as a change agent, and adapt to a rapidly changing organization and business environment.
  • Must have the ability to demonstrate innovative thinking to allow for optimal design and execution of clinical development strategies.
  • This position will require up to 10% travel.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Raritan- Other Locations
United States-Pennsylvania-Chesterbrook, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Switzerland-Basel-City-Basel, Netherlands-North Brabant-Breda, Netherlands-South Holland-Leiden, United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
3659200920

Am 22.11.2020 veröffentlicht. Originalanzeige