Global Clinical Operations, Strategy Implementation Leader
EMD Serono, Inc. - Billerica, MA

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.


Global Implementation of major GCO projects, e.g. the CRO Partnership, at Merck/EMD Serono

Overall accountability for the planning and implementation of the outsourcing strategy at Merck Serono (or other major projects as applicable and line with company strategy and priorities)

Define and maintain a project plan for enterprise-wide implementation of the CRO Partnership , including operational, financial as well as legal aspects

Apply in-depth understanding to implement best project management practices to the successful implementation of the outsourcing strategy

Design and apply state of the art Change Management approach and practices to ensure assimilation and enterprise-wide acceptance of the strategy

Interact with the functions to collect requirements and feedback for the continuous improvement of the process landscape

Develop all tools and processes to ensure consistency in implementation

To represent the Project in front of Merck Serono or CRO Senior Leadership with regards to all matters of Partnership Implementation

Provides key strategic input towards the implementation of innovative CRO Alliance Model

Ensure timely implementation and transition of all trials and clinical programs into the new operating model

Ensure development of all communication and training materials as well as conduct of change management interventions, communication or training of all affected stakeholders (with internal or external partners as applicable).

Develop all tools and process to allow the highly effective oversight and management of the partnership (includes Governance charters, KPI generating tools, reports, templates, etc.

Strategy Implementation Leadership at EMD/Merck Serono

Lead and drive a large cross-functional team that together with our Partner CRO and other external partners, like e.g. Change Management consultants, establishes industry-leading best practices for the way sponsors and CROs collaborate.

Translate project management methods and processes into operational workflows to allow an efficient use of the tools during and also after the implementation.

Ensure the fast adaptation to organizational changes.

Design, develop, test and implement new clinical trial processes and enhancements based on a continuous evaluation of their use and usability in supporting the clinical development processes at EMD/Merck Serono.

Continuous refinement of the model over time

Proactive collaboration with all key stakeholders in particular with Corporate Procurement and Controlling.

Removal of all barriers precluding successful implementation of the strategy.

Provide mentorship to the Excellence Management staff in Clinical Strategic Partnering


Critical role that drives high implementation of transformation process in GDM with anticipated total financial efficiency gains of 20% over 3 years for a global spent of > € 200 mio per annum.


Ensures implementation of major GDM strategic project – CRO Partnership Model

Ensures continuous improvement and lean mentality in broader organization in line with the partnership model


Critical stakeholder management across the R&D value chain: Decision makers, function heads, and teams

Builds cross-functional partnerships and influences without authority

Routine collaboration with and influence management of senior stakeholders (L2)

Represents company at industry conferences

Represents company with external collaborators, for CRO Partnership Model as well as industry benchmarking




Advanced scientific degree (MS or PhD) or equivalent industry experience

Highly developed written and verbal communications skills in English, second language a benefit


6-10 years of experience in various aspects of clinical development process especially clinical operations, outsourcing and strategic alliances

Several years of international experience and demonstrated success in leadership/managerial position(s) involving influence and interaction with other departments

Demonstrated success as change leader with international change management experience

Complex project management experiences

Sound awareness of the pharmaceutical business and trends in the industry


Strong leadership, and influencing skills effective at a senior level in the organization

Clear results orientation

Strong analytical skills and ability to understand complex processes and to problem solve effectively

Ability to lead and follow several projects at the same time.

Adaptability and flexibility to switch between projects, priorities if necessary

Strong interpersonal skills and ability to interact constructively with all functions and management levels in the organization.

Excellent top class verbal and written communication skills with proven ability to put together well-structured presentations for various forums.

Capability to participate in complex strategy formulation. Lateral thinking capability is vital.

Ability to represent the company and to negotiate at all levels both internally and externally

Facilitation and mediation skills

Effective conflict resolution skills

ADA REQUIREMENTS (mandatory for US employees)

Normal and routine office duties

Position requires both domestic and international travel up to 50% of time

Equal Employment Opportunity

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination


EMD Serono - 17 months ago - save job - block
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