Executive Director, Clinical Research, UK

Executive Director, Clinical Research, UK & Ireland

This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.

Job Description

Our Clinical Research team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

As an Executive Director of Clinical Research, you will be the Clinical Operations lead for the UK & Ireland and responsible for the execution of all Clinical Trials in scope for the cluster operations. As a leader, you will act as a role model to create an empowering, compliant, collaborative, and innovation-focused work environment.

You will ensure adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready clinical studies whilst being accountable for trial quality, audit responses and completion of CAPAs. You will ensure a single point of contact for managing clinical trial execution in all its aspects across phases in scope of Global Clinical Trial Operations for the UK&I.

Your role will be based at our Moorgate, London offices where we operate a hybrid working model.

In this role, you will:

Lead the UK&I Clinical Trial Operations leadership team, leading strategic development of the UK&I to deliver clinical trials as per our growing global clinical research pipeline requirement

Be the strategic cluster representative for initiatives at all levels of the organization

Build and lead the cluster team to effectively manage resources, ensuring appropriately skilled and high performing teams to effectively deliver the study portfolio across our therapy areas to achieve on our objectives

Lead the strategic development and management of institutional & investigator relationships in conjunction with our company's research division's Therapy Areas

Work with our regional and global colleagues, developing and executing the Clinical Trial Operations strategy for the UK&I - such as Industry associations

Lead and Manage the UK&I Clinical Trials Organisation:

Recruit, hire, proactively manage and develop talent – in addition to creating an empowering, compliant, collaborative, and innovation-focused work environment

Proactively identify new opportunities and gaps to support emerging needs and addresses them by reallocating and training of existing staff and/or external recruitment

Build a culture of quality and compliance through training, oversight, and collaboration

Oversight to ensure appropriate scientific and operational training for staff members

Lead and oversee:

Clinical Trial Operations and research division's goals, initiatives and expectations

Development and delivery of company standards in the UK&I

Activities of all cluster level teams, programs and studies

Country level operational study budgets

Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs

Responsible and supports development of audit responses and completion of CAPAs.

Collaborate, Support and Engage Key External Stakeholders:

Functional Service Provider (FSP): Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio

Support the development and management of Investigator and operational relationships in conjunction with all research division's Therapy Areas, and when appropriate – Human Health colleagues

Contribute to the program life-cycle management through effective study allocation and execution (prioritising programs, working with Key Opinion Leaders etc.).

Quality / Compliance Adherence / Standard:

Ensure that compliance, quality and timeline objectives are met for all trials executed in the cluster.

Sets clear performance standards and holds self and organisation accountable for achieving results.

Work collaboratively in a matrix organisation with all groups within Clinical Trials, especially with Clinical Sciences and Study Management in our US headquarters, Clinical Quality Managers and Regional Operations Teams, to deliver objectives

Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council.

To be successful in this role, you will need:

Bachelor's degree in Science or equivalent healthcare experience is required, advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA) is preferred.

Significant experience in Clinical Trials.

Proven leadership experience, preferably in the pharmaceutical or biotech company.

Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders in a matrix organization.

Strategic thinking

Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery.

A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.

Strong Communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication.

High emotional intelligence

Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

Positive proven success in people management

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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

This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.

Job Description

Our Clinical Research team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

As an Executive Director of Clinical Research, you will be the Clinical Operations lead for the UK & Ireland and responsible for the execution of all Clinical Trials in scope for the cluster operations. As a leader, you will act as a role model to create an empowering, compliant, collaborative, and innovation-focused work environment.

You will ensure adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready clinical studies whilst being accountable for trial quality, audit responses and completion of CAPAs. You will ensure a single point of contact for managing clinical trial execution in all its aspects across phases in scope of Global Clinical Trial Operations for the UK&I.

Your role will be based at our Moorgate, London offices where we operate a hybrid working model.

In this role, you will:

• Lead the UK&I Clinical Trial Operations leadership team, leading strategic development of the UK&I to deliver clinical trials as per our growing global clinical research pipeline requirement
• Be the strategic cluster representative for initiatives at all levels of the organization
• Build and lead the cluster team to effectively manage resources, ensuring appropriately skilled and high performing teams to effectively deliver the study portfolio across our therapy areas to achieve on our objectives
• Lead the strategic development and management of institutional & investigator relationships in conjunction with our company's research division's Therapy Areas
• Work with our regional and global colleagues, developing and executing the Clinical Trial Operations strategy for the UK&I - such as Industry associations

Lead and Manage the UK&I Clinical Trials Organisation:

• Recruit, hire, proactively manage and develop talent – in addition to creating an empowering, compliant, collaborative, and innovation-focused work environment
• Proactively identify new opportunities and gaps to support emerging needs and addresses them by reallocating and training of existing staff and/or external recruitment
• Build a culture of quality and compliance through training, oversight, and collaboration
• Oversight to ensure appropriate scientific and operational training for staff members

Lead and oversee:

• Clinical Trial Operations and research division's goals, initiatives and expectations
• Development and delivery of company standards in the UK&I
• Activities of all cluster level teams, programs and studies
• Country level operational study budgets
• Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs
• Responsible and supports development of audit responses and completion of CAPAs.

Collaborate, Support and Engage Key External Stakeholders:

• Functional Service Provider (FSP): Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio
• Support the development and management of Investigator and operational relationships in conjunction with all research division's Therapy Areas, and when appropriate – Human Health colleagues
• Contribute to the program life-cycle management through effective study allocation and execution (prioritising programs, working with Key Opinion Leaders etc.).

Quality / Compliance Adherence / Standard:

• Ensure that compliance, quality and timeline objectives are met for all trials executed in the cluster.
• Sets clear performance standards and holds self and organisation accountable for achieving results.
• Work collaboratively in a matrix organisation with all groups within Clinical Trials, especially with Clinical Sciences and Study Management in our US headquarters, Clinical Quality Managers and Regional Operations Teams, to deliver objectives
• Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council.

To be successful in this role, you will need:

• Bachelor's degree in Science or equivalent healthcare experience is required, advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA) is preferred.
• Significant experience in Clinical Trials.
• Proven leadership experience, preferably in the pharmaceutical or biotech company.

Competency Expectations:

• Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders in a matrix organization.
• Strategic thinking
• Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong Communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication.
• High emotional intelligence
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of our company.
• Positive proven success in people management

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/21/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/21/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R296808

Send me alerts about jobs like this.

Please enter your email address to continue setting up an email alert for similar jobs to this one. By entering your email address and clicking apply you will sign up to Jobs4 and agree to our terms and conditions .

Job Overview

ID:

1139098

Date Posted:

Posted 1 day ago

Expiration Date:

03/07/2024

Location:

Ec1

Competitive

Send me alerts about jobs like this.

Please enter your email address to continue setting up an email alert for similar jobs to this one. By entering your email address and clicking apply you will sign up to Jobs4 and agree to our terms and conditions .

Share

Complete the form below to send this job to a friend.

Job Location

Complete the form below to report this job.

#J-18808-Ljbffr

---