Area Head, Global Site Management & Monitoring Nordics/ BeNeLux/ UK/ Switzerland/ Austria

Req #: 1804312
Location:Boudry, NeuchatelCH
Job Category:Clinical Development
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene R&D Sarl
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibities may include, but are not limited to:

Execution:

• Execute tasks and responsibilities that deliver corporate goals and drive goal setting for the team members


• Assure staff’s adherence to SOPs, WPs, GCP, EU and local regulations as well as compliance standards


• Identify, prepare and deliver training at a regional and global level on complex organizational topics. (e.g. corporate initiatives)


• Line manage and develop others. Give clear, motivating and constructive feedback; provide challenging assignments to facilitate individual development; willingly share expertise and experience with others. Serve as a resource, coach and mentor.


• Provide specific project / study support as appropriate.


• Manage resource requirements ensuring appropriate levels of resources are available for the execution and oversight of clinical trials

• Make decisions independently and action them appropriately


• Set own priorities for activities that are required to achieve the corporate objectives


• Identify, develop and implement initiatives and best practices


• Identify process improvements, gain approval and as appropriate, drive the development and execution of processes and documentation to support the changes

Communication:

• Set clear expectations and provide appropriate autonomy and performance measurements

• Provide constructive feedback and can motivate others


• Influence key stakeholders outside of the team and capitalize on established relationships / networks


• Inform team members and cross functional parties on a timely basis of programs / project updates.


• Excellent oral and written skills and ability to effectively apply these skills

Teamwork:

• Collaborate with both regional and international Medical, Clinical Operations colleagues, Affiliates and other relevant departments to support clinical programs, ensuring effective management of Celgene sponsored studies


• Act as a Subject Matter Expert and escalation resource to other functional areas (e.g. Affiliates, study teams & CRO)

• Demonstrate a strong business acumen and the ability to view issues from multiple functional perspectives


• Ability to navigate in a complex internal structure / environment and commit to the targets and deliver despite unforeseen events


• Demonstrate advanced leadership skills for individuals and teams across the organization


• Capitalize on broad, well established relationships and networks


• Provide constructive feedback and has the ability to motivate others

• Serve as resource or mentor on operational issues


• Model and promote positive team behaviors in a cross-functional atmosphere


• Develop / maintain relationships with external partners / stakeholder as needed


• Collaborate with colleagues within Clinical Operations and from other functions to maximize efficiencies, share and apply best practices

Innovation:

• Set own priorities for activities that are required to achieve the corporate objectives


• Identify, recommend, and where appropriate, implement solutions to problems and/or issues with personnel and / or processes across departments.

• Act as a change agent in a rapidly transforming organization


• Open-minded to new ways and new ideas


• Provide direction for quality improvements and strategies

Adaptability:

• Respond resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute. Translate the organization’s vision and strategies into meaningful plans for the function, connecting them to the mission of each team.


• Perform other duties as assigned by management

• Identify critical issues internally and externally that may impact execution of the clinical trials in their region or beyond

Strategy:

• Provide strategic and operational input regarding adequacy and feasibility of clinical programs and studies of the development program

• Recognize market opportunities for both new and current products, acts accordingly and takes risk when opportunities arise


• Display a willingness to challenge the status quo and take risks


• Make sound decisions that align with Celgene’s goals and strategy


• Maintain focus on strategic objectives while accomplishing operational goals


• May be considered a strategic expert within the function


• Drive strategic planning and execution of insourced monitoring activities across multiple clinical programs to ensure timely and high-quality project deliverables


• Strategically assess study / program metrics and ensures implementation of appropriate measures as necessary to support project or program targets / deliverables

Risk Management:

• Provide CRO oversight as appropriate


• Identify and action trend and metric issues for broader impact through root-cause analysis when necessary, develop, direct and implement mitigation strategies, and ensure resolution.

• Can solve multiple problems with varying degrees of complexity

• Identify and where appropriate create local / regional process solutions that may be able to be applied globally

Global Mindset:

• Collaborate cross-functionally regionally and globally with a view to ensuring trials meet timelines and quality


• Assess, propose, and implement solutions for the impact of new laws and regulations


• Ability to think globally and act locally with sensitivity to cultural differences


• Proactively keep up to date with business environment and therapeutic areas


• Consider global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.


• Cultivate networks of people across a variety of functions, locations, and geographies.


• Develop and maintain effective working relationships with people across cultures

Skills/Knowledge Required:

• Experienced clinical R&D professional with knowledge of industry trends and experience in leading and driving operational programs and initiatives


• Ability to establish a team strategy and link team and employee objectives to the strategy


• Proven track record to drive multi-national teams to deliver on business and program goals


• Disease / therapeutic knowledge / expertise highly desirable


• In depth knowledge of ICH/GCP, regulatory guidelines / directives and drug development process


• Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial/marketing)


• Have a solid understanding of the cross functional components that impact clinical trials and integrate appropriate input arising from internal and external team members into the clinical operation strategy


• Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation and execution


• Ability to lead and drive program planning and delivery in collaboration with CRO partners


• Understanding of financial and resourcing principles and utilization of this knowledge to make sound business decisions.

• Demonstrated ability to make independent decisions and manage conflicting priorities in a fast-paced environment. Must be responsive and willing to take ownership of issues and drive solutions

• Proven communication, coaching and interpersonal skills, at all levels of the organization


• Team player able to work closely with a global team and open to sharing information and best practices with the team


• Demonstrated quality-driven orientation and execution focus. Strong track record of working collaboratively to tackle cross-functional business issues


• Ability to work in multicultural teams. Effective teamwork and teambuilding skills transferable across functional levels


• Time management - ability to effectively multi-task and prioritize in matrix environment

PREREQUISITES

• Clinical / healthcare scientific degree (advance degree preferred or equivalent industry experience)


• Minimum of 10 years of operations and research management experience, including 5 years of line management experience.


• Knowledge of European regulatory requirements and regulations/laws pertaining to GCP