Job Detail

JOB DESCRIPTION

Job Description

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.

The Oncology Clinical Director is a therapeutic and disease area expert who is responsible for supporting clinical development activities across the Europe, Middle East and Africa (EMEA) region. This position will report to the Oncology Therapeutic Area Head, European Clinical Development.

Primary Activities:

• Responsible for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs being developed within the Oncology therapeutic area.


• Provide EU perspective and input on protocol design and support recruitment and study management activities in the EMEA region including global study program leadership.


• Responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring of Phase I to IV clinical trials, as well as analysis, interpretation and reporting of final clinical trial results.


• Responsibilities also include presentation of research findings at international scientific meetings and providing European clinical insights from a network of scientific leaders and oncology societies into our development programs.


• He/she will be a member of relevant Clinical Sub Teams, Clinical Science Study Management (CSSM) teams and an ad hoc attendee at Product Development Team (PDT) meetings, also influencing and supporting across Clinical Development, Clinical trial operations, Regulatory affairs, Safety Risk management and Business Development & Licensing functions regionally.


• He / She will work closely and align with the relevant Global Product Development Teams / Clinical Science Study Management indication specific leads on EMEA regional clinical trial responsibilities


• To provide clinical support to the EMEA Global Clinical Trial Organisation, Regulatory affairs, incl. Regulatory Policy, Scientific Affairs, Medical Affairs and Business Development & Licensing functions within our Research and Development division for the Oncology Therapeutic area.


• Identifies, establishes and maintains collaborative scientific relationships with key investigators, institutions, groups and consortia to identify and address scientific needs and stay abreast of current scientific trends in Oncology.


• The Clinical Director will also contribute to establishing Oncology Clinical Development Strategies and executing on short- and long-term research objectives.


• Support in creating a community of physicians within the organisation – from Development to country based Medical Directors, Medical Affairs Managers and Medical Science Liaisons.


• Fully comply with all company policies and applicable laws, regulations, and ethical standards.

Qualifications: 

Education:

Required:

• MD or PhD

Preferred:

• MD


• Additional advance degree , eg. MSc, PhD

Experience and skills:

Required: 

• Board certified / eligible in oncology related clinical field and/or Industry Oncology Clinical Development experience


• Strong interpersonal skills, as well as the ability to function in a multidisciplinary team environment 


• Excellent communication and writing skills


• Strong analytical skills

 Preferred:

• Research background in design and implementation of clinical studies, familiarity with biostatistics, and/or EMA/FDA regulatory review process is desirable


• Clinical/translational research experience with evidence of strong scientific productivity such as authorship on published manuscripts


• Proven leadership skills with ability to create and work in high performance teams and/or matrix organization


• Must be able to collaborate to resolution and articulate clear scientific strategy


• Prior pharmaceutical industry experience 

 Travel requirements: extensive travel within the region/international

Professional Competencies

Business Acumen

Demonstrates skill incorporating financial data and deep industry knowledge to identify key business opportunities. Demonstrates skill using business knowledge and knowledge of -our company’s operations to weigh risks and trade-offs for implementing industry innovations. Demonstrates the ability to utilize industry trends and knowledge of our company’s operations to determine own function’s strengths and weaknesses. Demonstrates the ability to provide guidance to others when interpreting financial data and insight to our company’s structure and operations.

Working Across Boundaries

Demonstrates the ability to champion global integration and coalition around core business strategies. Demonstrates skill in influencing others to pursue alignment among their divisions/geographical locations. Demonstrates the ability to provide guidance to others on implementing corporate practices while tailoring them to the region.

Strategic Thinking

Demonstrates the ability to champion the evolution and implementation of policies, practices and core values for the continued success of our company. Demonstrates industry foresight that allows prediction of future trends and challenges, identification of long-term opportunities and the development of a strategic plan to lead the organization going forward. Demonstrates the ability to champion innovation as a core business strategy providing guidance to others on developing a more strategic mind set and promoting innovation in their function. Demonstrates the ability to obtain strategic alignment from key stakeholders around new initiatives and development of a shared vision for the organization.

Project Management

Demonstrates the ability to effectively scope, assign tasks and allocate resources for meeting goals within project budget. Demonstrates the ability to foresee possible risks to project goals and deadlines and create pre-emptive solutions. Demonstrates the ability to provide guidance to others in project management and task completion. Demonstrates the ability to create accountability among project team members to drive on-time delivery of products.

Productive Communication

Demonstrates the ability to deliver sensitive and difficult messages with tact, diplomacy, and understanding of the target audience. Demonstrates the ability to connect with others on a personal level while remaining sensitive to individual differences in order to influence others’ and inspire their support.

Demonstrates the ability to act as our company spokesperson, often being called upon to deliver high impact or significant business information to external audiences.

Problem Solving

Demonstrates the ability to identify and integrate patterns, trends and inconsistencies across multiple data sources to determine their broader implications. Demonstrates the ability to coach others in the use of problem-solving tools and techniques encouraging others to think creatively to achieve new solutions.

Demonstrates the ability to quickly identify potential sources of problems and develop imaginative solutions. Demonstrates the ability to make unique, insightful observations that help drive solutions.

Demonstrates the ability to accelerate the decision-making process around complex issues by generating original, user friendly solutions.

Functional Competencies

Research Design & Execution

Oversees and/or executes the design, planning, and performance of innovative scientific/research/ development activities leveraging leading-edge approaches (eg, adaptive study design) to the most complex projects. Viewed as subject matter expert in identifying and developing leading edge research tools, methodologies and data management tools and standards for research activity execution. Engages with external stakeholders as a subject matter expert and brings innovative techniques to our company and encourages their application.

Data Analysis, Interpretation & Communication

Plans, designs, and executes advanced analysis and advises on the use of available technologies and tools. Teaches/coaches others to synthesize and critically evaluate data to inform decisions related to experiment/study plans and priorities. Leverages the use of data to communicate insightful and persuasive results to a variety of audiences and effectively authors complex written documents (eg, memos, slide decks, strategy documents).

Collaboration & Partnering

Collaborates with existing, and builds new relationships with, internal stakeholders. Serves as a key R&D contact across all our company’s functions to diversify thinking and drive innovation. Seeks new, dynamic relationships with external stakeholders that add value, diversity, and innovation to our company’s pipeline. Expert in navigating industry-leading collaborations/partnerships, and creatively inspires diverse groups of internal and external stakeholders to follow a specific course of action or align around a vision/path forward.

         

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R36232