Director, Global Clinical Supply Project Management (Hybrid)
Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Research & Development Division portfolio of clinical trials.
GCS supports more than 300 Phase I-IV clinical trials run in-house, 400
outsourced or run by partners, and 300
our company's ISS clinical trials.
GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites across more than 60
countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures.
The GCS Clinical Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.
Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical study demand into supply plans and are accountable for all delivery of clinical finished goods materials to initiate trials on time and maintain patient continuity of supply.
Reporting to the Section Head of one of the Therapeutic Areas, the incumbent will have responsibility to manage a team of Clinical Supply Planning Managers (CSPM) responsible for managing supporting clinical supply programs, protocols and/or inventory.
Responsibilities may also include assignments of varying phase, complexity, priority & involvement with external collaboration partners.
Primary
Responsibilities:
Manages, directs, and influences clinical supply planning strategy, design and execution for multiple highly complex programs ensuring scientific consistency and quality development across multiple key clinical programs within a Portfolio.
Accountable to Sr.
Management for communication of progress, status updates, mitigation plans and escalation of issues for clinical supply deliverables across the portfolio for Phase I thru Phase IV including IIS and collaborative studies.
Facilitates strategic and operational input, maintenance and continued evaluation of clinical supply chain plans across programs.
Partners with key stakeholders to align with the vision and strategy and to ensure clinical supply timelines and deliverables are met across programs (including joint ventures, collaborations, due diligence, etc.
).
Partners with key stakeholders on leadership teams to build alliances, drive the direction of the business, leverage best practices, and develop leading indicator values for risk, change control, and business continuity.
Keeps abreast of pharmaceutical industry best practices, regulatory and GMP requirements and corporate strategies that impact the organizationManages the multi-million dollar clinical supply drug product budget across the assigned Portfolio.
Works cross-functionally with Clinical Research and Operations, Business Analytics, Finance, and other critical stakeholders to support the needs, influence and drive business performance, and ensure effective planning strategies for clinical supplies.
Responsible for resource management and deployment for the Portfolio, including hiring and staffing.
Determines resource needs through the review of authorized and anticipated clinical development activities and applied knowledge of functional area and/or specific resource demands.
Manages and provides feedback and developmental opportunities for direct reports and staff.
Provides mentoring for planning managers and team leads.
Functions as representative or leads cross-functional /cross-divisional projects and initiatives.
Additional
Responsibilities:
Coach and mentor staff in the nuances of managing a development project:
management of team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, coaching on our Research & Development Division/ our company's processes relating to development team management, PM skills, and team management.
Strengthen messaging via exhibition of our company's Leadership Behaviors (teach by example).
Work to ensure that PM best practices are being employed across projects.
Participate in continuous improvement projects that require extensive product development experience and understanding of our company's procedures and policies, and which significantly impact the work and / or effectiveness of PM.
These projects can relate to optimizing PM capabilities, systems, and operations (e,g.
, leading efforts to improve planning systems / platforms, etc.
) or to improving the functioning of teams and / or development processes.
These efforts may be within GCS or cross functional to assist other partner areas with their process improvement needs Required Education and
Experience:
Bachelor's degree with 15
years'; or Master's degree with 12
years'; or relevant career experience.
At least 5 years of experience in project management Strong understanding of drug development, clinical research, and/or clinical supply chain activities.
Strong interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.
People management and strong leadership skills.
Understanding of MRP systems and demand planning principles Strong organizational, time management and problem-solving skills Results oriented with the proven ability to execute on collaborative projects and develop subject matter expertise Exceptional written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.
Demonstrated ability to prioritize tasks and initiatives appropriately to mitigate supply risks.
Proficiency in Microsoft Excel, PowerPoint, and Word.
Experience with change management and leading process improvement initiatives.
Preferred Experience and Skills:
Extensive experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.
Demonstrates ability to resolve conflicts and engage in decision making as well as partner and influence across functional areas and organizations Strong knowledge of the principles of project management and clinical customer relationship management.
Knowledge of drug development, production, distribution, shipping, destruction, and reconciliation processes and procedures.
Knowledge of order management, supply chain operations and document control.
Familiarity with data analytics/visualization software.
Familiarity with SAP as an ERP/MRP system.
Familiarity with GMP requirements, quality procedures, and SOP execution.
We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world.
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.
Who we are We are known as Merck & Co.
, Inc.
, Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.
For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.
Here, you have that opportunity.
You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.
Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$159,200.
00 - $250,700.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/A Recommended Skills Business Analysis Business Continuity Business Process Improvement Change Control Change Management Clinical Research Estimated Salary: $20 to $28 per hour based on qualifications.
GCS supports more than 300 Phase I-IV clinical trials run in-house, 400
outsourced or run by partners, and 300
our company's ISS clinical trials.
GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites across more than 60
countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures.
The GCS Clinical Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.
Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical study demand into supply plans and are accountable for all delivery of clinical finished goods materials to initiate trials on time and maintain patient continuity of supply.
Reporting to the Section Head of one of the Therapeutic Areas, the incumbent will have responsibility to manage a team of Clinical Supply Planning Managers (CSPM) responsible for managing supporting clinical supply programs, protocols and/or inventory.
Responsibilities may also include assignments of varying phase, complexity, priority & involvement with external collaboration partners.
Primary
Responsibilities:
Manages, directs, and influences clinical supply planning strategy, design and execution for multiple highly complex programs ensuring scientific consistency and quality development across multiple key clinical programs within a Portfolio.
Accountable to Sr.
Management for communication of progress, status updates, mitigation plans and escalation of issues for clinical supply deliverables across the portfolio for Phase I thru Phase IV including IIS and collaborative studies.
Facilitates strategic and operational input, maintenance and continued evaluation of clinical supply chain plans across programs.
Partners with key stakeholders to align with the vision and strategy and to ensure clinical supply timelines and deliverables are met across programs (including joint ventures, collaborations, due diligence, etc.
).
Partners with key stakeholders on leadership teams to build alliances, drive the direction of the business, leverage best practices, and develop leading indicator values for risk, change control, and business continuity.
Keeps abreast of pharmaceutical industry best practices, regulatory and GMP requirements and corporate strategies that impact the organizationManages the multi-million dollar clinical supply drug product budget across the assigned Portfolio.
Works cross-functionally with Clinical Research and Operations, Business Analytics, Finance, and other critical stakeholders to support the needs, influence and drive business performance, and ensure effective planning strategies for clinical supplies.
Responsible for resource management and deployment for the Portfolio, including hiring and staffing.
Determines resource needs through the review of authorized and anticipated clinical development activities and applied knowledge of functional area and/or specific resource demands.
Manages and provides feedback and developmental opportunities for direct reports and staff.
Provides mentoring for planning managers and team leads.
Functions as representative or leads cross-functional /cross-divisional projects and initiatives.
Additional
Responsibilities:
Coach and mentor staff in the nuances of managing a development project:
management of team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, coaching on our Research & Development Division/ our company's processes relating to development team management, PM skills, and team management.
Strengthen messaging via exhibition of our company's Leadership Behaviors (teach by example).
Work to ensure that PM best practices are being employed across projects.
Participate in continuous improvement projects that require extensive product development experience and understanding of our company's procedures and policies, and which significantly impact the work and / or effectiveness of PM.
These projects can relate to optimizing PM capabilities, systems, and operations (e,g.
, leading efforts to improve planning systems / platforms, etc.
) or to improving the functioning of teams and / or development processes.
These efforts may be within GCS or cross functional to assist other partner areas with their process improvement needs Required Education and
Experience:
Bachelor's degree with 15
years'; or Master's degree with 12
years'; or relevant career experience.
At least 5 years of experience in project management Strong understanding of drug development, clinical research, and/or clinical supply chain activities.
Strong interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.
People management and strong leadership skills.
Understanding of MRP systems and demand planning principles Strong organizational, time management and problem-solving skills Results oriented with the proven ability to execute on collaborative projects and develop subject matter expertise Exceptional written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.
Demonstrated ability to prioritize tasks and initiatives appropriately to mitigate supply risks.
Proficiency in Microsoft Excel, PowerPoint, and Word.
Experience with change management and leading process improvement initiatives.
Preferred Experience and Skills:
Extensive experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.
Demonstrates ability to resolve conflicts and engage in decision making as well as partner and influence across functional areas and organizations Strong knowledge of the principles of project management and clinical customer relationship management.
Knowledge of drug development, production, distribution, shipping, destruction, and reconciliation processes and procedures.
Knowledge of order management, supply chain operations and document control.
Familiarity with data analytics/visualization software.
Familiarity with SAP as an ERP/MRP system.
Familiarity with GMP requirements, quality procedures, and SOP execution.
We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world.
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.
Who we are We are known as Merck & Co.
, Inc.
, Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.
For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.
Here, you have that opportunity.
You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.
Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$159,200.
00 - $250,700.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/A Recommended Skills Business Analysis Business Continuity Business Process Improvement Change Control Change Management Clinical Research Estimated Salary: $20 to $28 per hour based on qualifications.
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