Senior Director, Data Management Portfolio Delivery OncologyHematology

Warren, OH - USA

Monthly Salary: $ 216100 - 360200

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

Regeneron is seeking a Senior DirectorData Management Portfolio Deliveryfor our Oncology/Hematology therapeutic areas.

In this role a typical day might include:

The Senior DirectorData Management Portfolio Deliveryis a member of the Data ManagementSeniorLeadership Team(DMSLT)andcontributesto the visiondirectionand strategyof theline functionin support of theadvancementofRegeneronsclinical incumbent willberesponsible forleading managing and developinga team of highly engaged data managers and portfolio leads. Additionallythis role is accountable foreffective oversight andtimelydelivery of all clinical data management activitiesfrom study start-upthrough archivalacrossmultiple studies inone or moretherapeutic area(s)ensuringfit-for-purpose clinical dataandcompliance withRegeneron procedures and applicable regulatory requirements.
This positionrequiresadvanced knowledge of Electronic Data Capturesystemsrelated applicationsindustrystandardsand regulatory requirementsas well asprogressiveexperienceworking onPhase I-IV studiesandparticipatinginregulatory submissions and health authorityinspectionswithin the medical device and/orpharmaceutical industry.
TheSenior Director Data ManagementPortfolio Deliverywillcollaboratecloselywith the Clinical Data Management Central Services Clinical Data Operations and External DataAcquisitionand Delivery Teams alongwith internalstakeholders and externalvendorsatdifferent levelsto ensurecontinuousimprovement and successful outcomes forstudies/programs.

This role might be for you if you can/have:

Contribute to theoverallvision direction and strategy for Data Managementline functionand assigned therapeutic area(s).
Accountableforoperational execution anddelivery of quality fit-for-purpose data in support of statistical analyses acrossstudieswithinassigned therapeutic area(s); provide comprehensive and effective oversight of FSPsandexternalpartners.
Perform evaluation of resource demand and allocationacrossstudies/programsto ensure adequate staffing andhigh levelsof productivity in support of departmentalobjectivesand corporate level portfolio delivery goals; select and recruit top industry talent and provide constructive performance appraisals to ensure professional growth and development.
Monitor groups performance with respect to qualityadherence to standardscompliance with the established SOPs WIsandapplicable regulations; ensurecontinuousinspectionreadiness.
Proactivelyidentifyissuesand propose solutions to mitigate operational risksand/or escalationsfor the function; providestrongleadershipsupport for critical study data management milestones.
Lead strategic cross-functional initiatives to promote increased process efficiency and operational excellence; drive optimization of technology systems and processes focusing on decreased cycle times improvedqualityand inspection readiness.
Liaise withinternal and external stakeholdersto foster strong relationships and ensure effective cross-functional collaboration and communication throughoutdrugdevelopment process.
Author and contribute to the development of global clinical data management SOPs/WIs andcorrespondingdepartmental training curricula.
Demonstrate company values and act as a role model by promoting competence collaboration innovation respectownershipand accountability.
Maintain awareness of Clinical Data Management emerging trends technologysolutionsand industry best practices through peer relationships with thought leaders in the industry; represent Regeneron in professional associations and forums.

To be considered for this opportunity you must have the following:

BachelorsDegree required Advanceddegreedesirable.
15 years of clinical data management experience in a pharmaceutical or biotech setting.
10 years of functional leadership
8yearsof people managementleadershipand mentoring experience
Leadership experience in Clinical DataManagementor related field leadingmidsizedglobal data managementgroups acrossvarioustherapeutic areas.
Expertisein clinical datamanagementprocesses industry bestpracticesand clinical data systems (EDC eSourceeCOA IRT Clinical Data Repository medical terminology coding solutions laboratory normal range repositories).
Advancedknowledge of clinical data management principlestechnologiesregulationsand best practices including21 CFR Part 11 ICH-GCP GuidelinesGxPcomplianceand GDPRrelated to data acquisition processinghandlingand reportingused in drug development.
Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry.
Demonstrated success in solving complex business problems strategic thinking organizational design leading through periods ofsignificant change i.e. operating model shiftsdynamic portfolioexpansioncompanyand/or asset acquisitions.
Ability to build relationships with key internal and external stakeholders atleadership levels and across levels by negotiating effectively managing conflictsescalationsand collaborating successfully.
Provenability toestablishhighlymotivated andperformingteams with a focus on transformationinnovationand operational excellence.
Excellent interpersonal oral and written communication skills.
Ability to adjustina fast-pacedenvironment.
May require up to 25% travel.

#GDBDMJobs

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$216100.00 - $360200.00

Required Experience:

Exec

Regeneron is seeking a Senior DirectorData Management Portfolio Deliveryfor our Oncology/Hematology therapeutic areas.In this role a typical day might include:The Senior DirectorData Management Portfolio Deliveryis a member of the Data ManagementSeniorLeadership Team(DMSLT)andcontributesto the visio...

Regeneron is seeking a Senior DirectorData Management Portfolio Deliveryfor our Oncology/Hematology therapeutic areas.

In this role a typical day might include:

The Senior DirectorData Management Portfolio Deliveryis a member of the Data ManagementSeniorLeadership Team(DMSLT)andcontributesto the visiondirectionand strategyof theline functionin support of theadvancementofRegeneronsclinical incumbent willberesponsible forleading managing and developinga team of highly engaged data managers and portfolio leads. Additionallythis role is accountable foreffective oversight andtimelydelivery of all clinical data management activitiesfrom study start-upthrough archivalacrossmultiple studies inone or moretherapeutic area(s)ensuringfit-for-purpose clinical dataandcompliance withRegeneron procedures and applicable regulatory requirements.
This positionrequiresadvanced knowledge of Electronic Data Capturesystemsrelated applicationsindustrystandardsand regulatory requirementsas well asprogressiveexperienceworking onPhase I-IV studiesandparticipatinginregulatory submissions and health authorityinspectionswithin the medical device and/orpharmaceutical industry.
TheSenior Director Data ManagementPortfolio Deliverywillcollaboratecloselywith the Clinical Data Management Central Services Clinical Data Operations and External DataAcquisitionand Delivery Teams alongwith internalstakeholders and externalvendorsatdifferent levelsto ensurecontinuousimprovement and successful outcomes forstudies/programs.

This role might be for you if you can/have:

Contribute to theoverallvision direction and strategy for Data Managementline functionand assigned therapeutic area(s).
Accountableforoperational execution anddelivery of quality fit-for-purpose data in support of statistical analyses acrossstudieswithinassigned therapeutic area(s); provide comprehensive and effective oversight of FSPsandexternalpartners.
Perform evaluation of resource demand and allocationacrossstudies/programsto ensure adequate staffing andhigh levelsof productivity in support of departmentalobjectivesand corporate level portfolio delivery goals; select and recruit top industry talent and provide constructive performance appraisals to ensure professional growth and development.
Monitor groups performance with respect to qualityadherence to standardscompliance with the established SOPs WIsandapplicable regulations; ensurecontinuousinspectionreadiness.
Proactivelyidentifyissuesand propose solutions to mitigate operational risksand/or escalationsfor the function; providestrongleadershipsupport for critical study data management milestones.
Lead strategic cross-functional initiatives to promote increased process efficiency and operational excellence; drive optimization of technology systems and processes focusing on decreased cycle times improvedqualityand inspection readiness.
Liaise withinternal and external stakeholdersto foster strong relationships and ensure effective cross-functional collaboration and communication throughoutdrugdevelopment process.
Author and contribute to the development of global clinical data management SOPs/WIs andcorrespondingdepartmental training curricula.
Demonstrate company values and act as a role model by promoting competence collaboration innovation respectownershipand accountability.
Maintain awareness of Clinical Data Management emerging trends technologysolutionsand industry best practices through peer relationships with thought leaders in the industry; represent Regeneron in professional associations and forums.

To be considered for this opportunity you must have the following:

BachelorsDegree required Advanceddegreedesirable.
15 years of clinical data management experience in a pharmaceutical or biotech setting.
10 years of functional leadership
8yearsof people managementleadershipand mentoring experience
Leadership experience in Clinical DataManagementor related field leadingmidsizedglobal data managementgroups acrossvarioustherapeutic areas.
Expertisein clinical datamanagementprocesses industry bestpracticesand clinical data systems (EDC eSourceeCOA IRT Clinical Data Repository medical terminology coding solutions laboratory normal range repositories).
Advancedknowledge of clinical data management principlestechnologiesregulationsand best practices including21 CFR Part 11 ICH-GCP GuidelinesGxPcomplianceand GDPRrelated to data acquisition processinghandlingand reportingused in drug development.
Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry.
Demonstrated success in solving complex business problems strategic thinking organizational design leading through periods ofsignificant change i.e. operating model shiftsdynamic portfolioexpansioncompanyand/or asset acquisitions.
Ability to build relationships with key internal and external stakeholders atleadership levels and across levels by negotiating effectively managing conflictsescalationsand collaborating successfully.
Provenability toestablishhighlymotivated andperformingteams with a focus on transformationinnovationand operational excellence.
Excellent interpersonal oral and written communication skills.
Ability to adjustina fast-pacedenvironment.
May require up to 25% travel.