Associate Director, Non Clinical Safety | Project Management
Job DescriptionSummary, Focus and PurposeAs an Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group, the successful candidate will be responsible for closely collaborating with Discovery Program Leaders (Discovery Team Reps), Compound Leaders (Early Development and Product Development Team Reps), and Therapeutic Area Leaders to support the technical, operational, and scientific aspects of drug development in NDS.
You will work cross-functionally in a highly matrixed organization to ensure successful and efficient coordination of nonclinical safety data in support of our Research & Development Division supporting discovery and development programs.
Key FunctionsThe primary focus of the position is the management/support of a diverse portfolio of drug programs in discovery, development (regulated GLP toxicology studies), and post marketing products.
You will be a key component that drives NDS execution of strategic aspects of drug development both internally/externally.
Interfacing with Operations - Project Planning (NDS) and impacted functional areas (e.
g.
in vivo/in vitro laboratories, outsourcing) on changes in study designs or timelinesRequesting studies and providing compound and study design information in the NDS study scheduling systemInteracting with Central Pharmacy (NDS) and other areas in Preclinical Development (PCD) and Discovery on drug supply, allocation or materials, formulation, and stability mattersDetermining drug requirements for NDS studiesRequesting, tracking, and assisting with the development of regulatory packages including but not limited to PSURs/DSURs, IBs, IND/IMPDs, and WMAsTracking regulatory agency comments and resolutionsProviding monthly tracking in a pipeline management tool for the status, issues, and resolution plans on all active programsEnsuring that program issues are appropriately escalated to NDS managementStandardizing and optimizing procedures and processes involved in compound development within NDS and across PCDTraining new Discovery Program Leaders and Compound Leaders in particular components of drug developmentResponsibility for independent projects/assignments related to nonclinical drug discovery and developmentEducation and ExperienceB.
A.
/B.
S.
or equivalent in biological, chemical or pharmaceutical/medical/regulatory sciences and five years of experience in NDS or similar functionPreferred:
M.
A.
/M.
S.
/MBA in the above sciences, business, or project management accreditation and 2
years of experience in NDS or similar functionExperience Skills KnowledgeUnderstanding of drug discovery and development processes, particularly as it relates to nonclinical aspects of discovery and development as well as familiarity with the broad scope of safety assessment studies that support drug discovery, clinical development, and marketing approvalEvidence of strong cross-functional collaborative skills and have the ability to maintain effective interactions in a matrixed environmentExcellent verbal and written communication skills and efficient organizational skillsEvidence of relevant project management skill-set along with the ability to execute program/independent projects, and balance activities for multiple projects simultaneouslyCapacity and flexibility to immediately and independently take on new urgent assignments, balance other work accordingly, and interface with other areas as needed to accomplish the assignmentHave a positive and open mindset and willingness to seek proactive and ongoing input from stakeholders, a passion to develop and learn new aspects of drug development, and is open to different ideas or ways of workingWe 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.
Residents of ColoradoClick here to request this role s pay range.
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 Supplement Pay 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.
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:
$118,640.
00 - $186,800.
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:
YesHazardous Material(s):
SummaryLocation:
USA - Pennsylvania - West Point; USA - New Jersey - Rahway; USA - California - South San Francisco (Grand Ave); USA - Massachusetts - Boston (MA Parcel B Laboratory)Type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
You will work cross-functionally in a highly matrixed organization to ensure successful and efficient coordination of nonclinical safety data in support of our Research & Development Division supporting discovery and development programs.
Key FunctionsThe primary focus of the position is the management/support of a diverse portfolio of drug programs in discovery, development (regulated GLP toxicology studies), and post marketing products.
You will be a key component that drives NDS execution of strategic aspects of drug development both internally/externally.
Interfacing with Operations - Project Planning (NDS) and impacted functional areas (e.
g.
in vivo/in vitro laboratories, outsourcing) on changes in study designs or timelinesRequesting studies and providing compound and study design information in the NDS study scheduling systemInteracting with Central Pharmacy (NDS) and other areas in Preclinical Development (PCD) and Discovery on drug supply, allocation or materials, formulation, and stability mattersDetermining drug requirements for NDS studiesRequesting, tracking, and assisting with the development of regulatory packages including but not limited to PSURs/DSURs, IBs, IND/IMPDs, and WMAsTracking regulatory agency comments and resolutionsProviding monthly tracking in a pipeline management tool for the status, issues, and resolution plans on all active programsEnsuring that program issues are appropriately escalated to NDS managementStandardizing and optimizing procedures and processes involved in compound development within NDS and across PCDTraining new Discovery Program Leaders and Compound Leaders in particular components of drug developmentResponsibility for independent projects/assignments related to nonclinical drug discovery and developmentEducation and ExperienceB.
A.
/B.
S.
or equivalent in biological, chemical or pharmaceutical/medical/regulatory sciences and five years of experience in NDS or similar functionPreferred:
M.
A.
/M.
S.
/MBA in the above sciences, business, or project management accreditation and 2
years of experience in NDS or similar functionExperience Skills KnowledgeUnderstanding of drug discovery and development processes, particularly as it relates to nonclinical aspects of discovery and development as well as familiarity with the broad scope of safety assessment studies that support drug discovery, clinical development, and marketing approvalEvidence of strong cross-functional collaborative skills and have the ability to maintain effective interactions in a matrixed environmentExcellent verbal and written communication skills and efficient organizational skillsEvidence of relevant project management skill-set along with the ability to execute program/independent projects, and balance activities for multiple projects simultaneouslyCapacity and flexibility to immediately and independently take on new urgent assignments, balance other work accordingly, and interface with other areas as needed to accomplish the assignmentHave a positive and open mindset and willingness to seek proactive and ongoing input from stakeholders, a passion to develop and learn new aspects of drug development, and is open to different ideas or ways of workingWe 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.
Residents of ColoradoClick here to request this role s pay range.
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 Supplement Pay 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.
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:
$118,640.
00 - $186,800.
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:
YesHazardous Material(s):
SummaryLocation:
USA - Pennsylvania - West Point; USA - New Jersey - Rahway; USA - California - South San Francisco (Grand Ave); USA - Massachusetts - Boston (MA Parcel B Laboratory)Type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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