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Job Details


Merck & Co, Inc

Senior Director, Global Clinical Supply Planning

Science and Research

Clinical Research Director

No

Rahway, New Jersey, United States

Job Description

The Global Clinical Supply (GCS) organization, within our company's Research Laboratories (Research Division), is accountable for managing the 'end-to-end' integrated clinical supply chain across all of the Research Division's portfolio to enable the execution of any clinical trial using a company asset. GCS supports more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced or run by partners, as well as our company's IIS clinical trials (200+) and External Collaborations (~200+). GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites accross more than 60+ countries, all in accordance with US and WW regulations, company policies and standard operating procedures.

In collaboration with the Executive Director of GCS Planning, the Senior Director Lead is responsible for the overall strategy, supervision and conduct of all operational clinical supply planning activities including all planning management and line management of colleagues.

Primary responsibilities:

  • Manage, direct, and influence clinical supply planning strategy, design and execution across the portfolio (Phase I thru Phase IV including IIS, collaborative and acquisition activities) ensuring scientific consistency and quality development. Accountable to Sr. Management for communication of progress, status updates, mitigation plans and escalation of issues for clinical supply deliverables and will facilitate strategic and operational input, maintenance and continued evaluation of clinical supply chain plans across the portfolio.

  • 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. Responsible for ensuring that direct reports maintain appropriate levels of knowledge and skill in order to effectively lead and support.

Additional responsibilities:

  • 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.

  • Significantly contributes to, leads and/or creates, development of departmental and project strategy and cross-functional /cross-divisional projects and initiatives.

  • Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

  • Provides critical input and/or direction into decisions as to how we invest our time, resources and spend across the functional area.

  • Drives business and project deliverables across the group through application of depth of expertise in own discipline and broad knowledge of other disciplines and acts as a resource for colleagues across multiple areas and sites providing real-time, proactive advice and guidance.

  • Collaborates with other leads to provide comprehensive oversight of the entire development portfolio.

  • Builds and enables effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness and acts as a Global Clinical Supply point of contact for global business functions.

  • 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, including ensuring the multi-million-dollar clinical supply drug product budget is supported across the Portfolio.

  • Contributes to the development and/ or revision of company policies, SOPs and training materials.

  • Keeps abreast of pharmaceutical industry best practices, regulatory and GMP requirements and corporate strategies that impact the organization.

Preferred Education and/or Experience:

  • Bachelor’s or Master’s degree with 8+ years’ relevant career experience.

  • Expert knowledge and understanding of Pharmaceutical and/or clinical drug development.

  • People management, excellent leadership and interpersonal skills.

Preferred Experience and Skills:

  • Superior oral (including presentation) and written communication skills applied in a global environment.

  • Excellent project management and organizational skills.

  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion and ability to negotiate.

  • Ability to partner and influence across functional areas and organizations and lead cross-functional teams of business professionals within and outside our Research Division.

  • Ability to analyze, interpret and solve complex problems.

  • Ability to think strategically and objectively and with creativity and innovation.

  • Ability to organize and manage multiple tasks at one time and meet deadlines.

NOTICE FOR INTERNAL APPLICANTS

In 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 HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description

L'organisation mondiale des approvisionnements cliniques, au sein des laboratoires de recherche de notre entreprise (Division de la recherche), est responsable de la gestion de la chaîne d'approvisionnement clinique intégrée dans l'ensemble du portefeuille de la division Recherche pour permettre l'exécution de tout essai clinique utilisant un actif de l'entreprise. L'organisation mondiale des approvisionnements cliniques prend en charge plus de 300 essais cliniques de phase I-IV menés en interne, plus de 400 externalisés ou gérés par des partenaires, ainsi que les essais cliniques IIS de notre société (200+) et les collaborations externes (~200+). L'organisation mondiale des approvisionnements cliniques est responsable de la planification, de l'approvisionnement, de l'étiquetage, de l'emballage et de la livraison des fournitures cliniques aux sites cliniques dans plus de 60 pays, le tout conformément aux réglementations américaines et mondiales, aux politiques de l'entreprise et aux procédures opérationnelles standard.

En collaboration avec le directeur exécutif, le(la) Directeur(rice) principal(e), Planification mondiale des approvisionnements cliniques est responsable de la stratégie globale, de la supervision et de la conduite de toutes les activités opérationnelles de planification des approvisionnements cliniques, y compris toute la gestion de la planification et la gestion hiérarchique des collègues.

Responsabilités principales :

Gérer, diriger et influencer la stratégie, la conception et l'exécution de la planification des approvisionnements cliniques dans l'ensemble du portefeuille (Phase I à Phase 4, y compris IIS, les activités de collaboration et d'acquisition) en garantissant la cohérence scientifique et le développement de la qualité. Responsable devant la direction principale de la communication des progrès, des mises à jour de l'état, des plans d'atténuation et de l'escalade des problèmes liés aux livrables d'approvisionnement clinique et facilitera la contribution stratégique et opérationnelle, la maintenance et l'évaluation continue des plans de chaîne d'approvisionnement clinique dans l'ensemble du portefeuille.

Responsable de la gestion et du déploiement des ressources pour le portefeuille, y compris l'embauche et la dotation en personnel. Détermine les besoins en ressources grâce à l'examen des activités de développement clinique autorisées et prévues et des connaissances appliquées du domaine fonctionnel et/ou des demandes de ressources spécifiques. Gère et fournit de la rétroaction et des opportunités de développement aux employé(e)s et le personnel. Fournit un mentorat aux gestionnaires de planification et aux chefs d’équipe. Responsable de veiller à ce que les subordonnés directs maintiennent des niveaux appropriés de connaissances et de compétences afin de diriger et de soutenir efficacement.

Responsabilités supplémentaires :

  • Collabore avec les principales parties prenantes pour s'aligner sur la vision et la stratégie et pour garantir que les délais d'approvisionnement clinique et les livrables sont respectés dans l'ensemble des programmes (y compris les coentreprises, les collaborations, la diligence raisonnable, etc.).
  • Collabore avec les principales parties prenantes des équipes de direction pour bâtir des alliances, déterminer l'orientation de l'entreprise, tirer parti des meilleures pratiques et développer des valeurs d'indicateurs avancés pour le risque, le contrôle des changements et la continuité des activités.
  • Contribue de manière significative, dirige et/ou crée, le développement de la stratégie du département et du projet et des projets et initiatives interfonctionnels/interdivisions.
  • Dirige, pilote, facilite et/ou soutient les activités de remédiation, de prévention ainsi que l'amélioration des processus et la formation, selon les besoins.
  • Fournit une contribution et/ou une orientation essentielle aux décisions quant à la manière dont nous investissons notre temps, nos ressources et nos dépenses dans le domaine fonctionnel.
  • Pilote les livrables commerciaux et de projets à travers le groupe en appliquant une expertise approfondie dans sa propre discipline et une vaste connaissance d'autres disciplines et agit comme une ressource pour les collègues de plusieurs domaines et sites en fournissant des conseils et des orientations proactifs en temps réel.
  • Collabore avec d'autres responsables pour assurer une surveillance complète de l'ensemble du portefeuille de développement.
  • Établit et permet des relations de travail efficaces avec les principales parties prenantes afin d'assurer et de maintenir la clarté des rôles et l'efficacité commerciale et agit en tant que point de contact de l'approvisionnement clinique mondial pour les fonctions commerciales mondiales.
  • Travaille de manière interfonctionnelle avec la recherche clinique et les opérations, l'analyse commerciale, la finance et d'autres parties prenantes essentielles pour répondre aux besoins, influencer et stimuler les performances de l'entreprise, et garantir des stratégies de planification efficaces pour les fournitures cliniques, notamment en garantissant le coût de plusieurs millions de dollars. Le budget des produits pharmaceutiques d’approvisionnement clinique en dollars est soutenu dans l’ensemble du portefeuille.
  • Contribue à l'élaboration et/ou à la révision des politiques, des procédures opératoires normalisées et du matériel de formation de l'entreprise.
  • Se tient au courant des meilleures pratiques de l'industrie pharmaceutique, des exigences réglementaires et Bonnes Pratiques de Fabrication et des stratégies d'entreprise qui ont un impact sur l'organisation.

Expérience requise :

  • Baccalauréat ou maîtrise avec plus de 8 années d'expérience professionnelle pertinente.
  • Connaissance et compréhension expertes du développement de médicaments pharmaceutiques et/ou cliniques.
  • Gestion des personnes, excellent leadership et compétences interpersonnelles.

Expérience et compétences requises:

  • Compétences supérieures en communication orale (y compris la présentation) et écrite appliquées dans un environnement mondial.
  • Excellentes compétences en matière de gestion de projet et d'organisation.
  • Excellentes compétences en matière de travail d'équipe et de leadership, y compris une expertise en matière de résolution de conflits, une discrétion et une capacité de négociation.
  • Capacité à établir des partenariats et à influencer des domaines fonctionnels et des organisations et à diriger des équipes interfonctionnelles de professionnels au sein et à l'extérieur de notre division de recherche.
  • Capacité à analyser, interpréter et résoudre des problèmes complexes.
  • Capacité à penser de manière stratégique et objective, avec créativité et innovation.
  • Capacité à organiser et gérer plusieurs tâches en même temps et à respecter les délais.

Nous sommes une société biopharmaceutique axée sur la recherche. Notre mission est fondée sur le simple fait que nous « respectons la science » et que les meilleurs médicaments peuvent impacter considérablement notre monde. Et nous croyons qu’une entreprise axée sur les recherches scientifiques de classe mondiale peut réussir en apportant des innovations aux médicaments et aux vaccins qui ont des effets concrets sur nos patients partout dans le monde.

US 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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, 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 - $250,700.00

Available 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.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R270002