Senior Manager, Clinical Supply

Cerevel Therapeutics, LLC

Boston, MA, USA Remote

Full time

Sep 9

Full Job Description

Company Overview

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.

Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

Reporting to Head of Clinical Supplies, the Senior Manager will manage day to day clinical supply activities and logistics within the Clinical Supply Operations group. This position will design, develop, and implement the clinical supplies strategy to ensure adequate study drug is available for all Cerevel clinical trials. This position is responsible for enabling the on-time delivery of clinical supplies for both medium and high complexity programs with significant technical and geographic complexity across the Cerevel portfolio. Primary focus of this role includes oversight of suppliers, software systems including forecasting and planning tools, inventory management system, and Interactive Response Technology Systems (IRT) to support Cerevel’s pipeline. Work closely with CMC, Clinical Operations, Regulatory, and QA to ensure clinical supplies for assigned programs are manufactured, packaged, labeled and distributed on time to support both early and late phase clinical trials. This includes but is not limited to assuring availability of drug product, interpreting clinical protocols, development of study and program forecasts and supply plans, and generation and maintenance of study-level budgets. This individual will work utilizing Cerevel’s outsourced model and the management of CMO and IRT vendors.

Key Responsibilities

  • Work with clinical study teams to develop clinical supply forecasts and supply plans and timelines
  • Monitor drug expiry and the appropriate inventory re-supply strategies for assigned clinical programs
  • Manage supply plan, inventory management, production, distribution, returns & destruction
  • Drive label creation and approval process, including translations for all countries, on assigned studies
  • Develop and implement a qualification software solution technology for forecasting and planning of Clinical Supply Chain pipeline
  • Oversight of key suppliers, working with Procurement by adopting Supplier Relationship Management tools (SRM) to key suppliers and compliance standards in supplier selection
  • Manage temperature excursions during transportation on assigned study
  • Manage return and destruction of IMPs from sites to depots for assigned study

Required Qualifications

  • Seven (7+) years of experience in managing Phase 1- Phase 3 global clinical trials in the Pharmaceutical and/or Biotech industry
  • Strong expertise in Excel, and IT solutions for inventory management, forecasting, planning, and simulation
  • Knowledge of import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance
  • Experienced working with third-party CMO clinical supply operations
  • Strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW and global country requirements
  • Knowledge of proper GMP/GXP trial documentation and identify what is required to be stored in the Trial Master File (TMF) regarding study drug documentation
  • Deep understanding of GMP/GXP requirements in clinical supplies
  • Strong project management, interpersonal, and communication skills
  • Ability to partner with the business functions in order to enable high quality outcomes

Desired Qualifications

  • Desire to work in a fast-pace, dynamic environment
  • Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations
  • Team player; effective listening, evaluation of issues and communication of mitigations
  • A high degree of autonomy; takes accountability for work
  • Very organized and efficient; delivers high-quality work

Education

  • B.S./M.S. in a scientific field

Company COVID-19 Vaccination Policy

  • The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law


#LI-EW1 Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.


Company Overview

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.

Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

Reporting to Head of Clinical Supplies, the Senior Manager will manage day to day clinical supply activities and logistics within the Clinical Supply Operations group. This position will design, develop, and implement the clinical supplies strategy to ensure adequate study drug is available for all Cerevel clinical trials. This position is responsible for enabling the on-time delivery of clinical supplies for both medium and high complexity programs with significant technical and geographic complexity across the Cerevel portfolio. Primary focus of this role includes oversight of suppliers, software systems including forecasting and planning tools, inventory management system, and Interactive Response Technology Systems (IRT) to support Cerevel’s pipeline. Work closely with CMC, Clinical Operations, Regulatory, and QA to ensure clinical supplies for assigned programs are manufactured, packaged, labeled and distributed on time to support both early and late phase clinical trials. This includes but is not limited to assuring availability of drug product, interpreting clinical protocols, development of study and program forecasts and supply plans, and generation and maintenance of study-level budgets. This individual will work utilizing Cerevel’s outsourced model and the management of CMO and IRT vendors.

Key Responsibilities

  • Work with clinical study teams to develop clinical supply forecasts and supply plans and timelines
  • Monitor drug expiry and the appropriate inventory re-supply strategies for assigned clinical programs
  • Manage supply plan, inventory management, production, distribution, returns & destruction
  • Drive label creation and approval process, including translations for all countries, on assigned studies
  • Develop and implement a qualification software solution technology for forecasting and planning of Clinical Supply Chain pipeline
  • Oversight of key suppliers, working with Procurement by adopting Supplier Relationship Management tools (SRM) to key suppliers and compliance standards in supplier selection
  • Manage temperature excursions during transportation on assigned study
  • Manage return and destruction of IMPs from sites to depots for assigned study

Required Qualifications

  • Seven (7+) years of experience in managing Phase 1- Phase 3 global clinical trials in the Pharmaceutical and/or Biotech industry
  • Strong expertise in Excel, and IT solutions for inventory management, forecasting, planning, and simulation
  • Knowledge of import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance
  • Experienced working with third-party CMO clinical supply operations
  • Strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW and global country requirements
  • Knowledge of proper GMP/GXP trial documentation and identify what is required to be stored in the Trial Master File (TMF) regarding study drug documentation
  • Deep understanding of GMP/GXP requirements in clinical supplies
  • Strong project management, interpersonal, and communication skills
  • Ability to partner with the business functions in order to enable high quality outcomes

Desired Qualifications

  • Desire to work in a fast-pace, dynamic environment
  • Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations
  • Team player; effective listening, evaluation of issues and communication of mitigations
  • A high degree of autonomy; takes accountability for work
  • Very organized and efficient; delivers high-quality work

Education

  • B.S./M.S. in a scientific field

Company COVID-19 Vaccination Policy

  • The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law


#LI-EW1 Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

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