Skip to main content

This job has expired

You will need to login before you can apply for a job.

Associate Director, Clinical Supply Chain

Employer
Day One Biopharmaceuticals
Location
Remote - Work From Home anywhere in US
Start date
Apr 11, 2024

View more

Discipline
Clinical, Clinical Research, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time

Job Details

ASSOCIATE DIRECTOR, CLINICAL SUPPLY CHAIN    
 
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
                                                                                   
 POSITION SUMMARY: 
 
The Associate Director, Clinical Supply Chain role will perform all clinical supply chain activities through all stages of a clinical trial, from start-up through study close-out.   

This position will report to the Chief of Technical Operations.

This position has the potential to be fully remote. Occasional travel will be required for in-person meetings.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
 
·       Oversee clinical supply activities including planning, labeling, packaging, and distribution of Clinical Trial Material (CTM) for multiple projects.
·       Interface with internal functions (i.e. Clinical Operations, Regulatory, GMP Quality Assurance, Manufacturing) to interpret CTM needs from study protocols, define packaging and labeling configurations, support regulatory filings, create, and maintain CTM documentation.
·       Partner with external vendors (Contract Manufacturing Organizations (CMOs), Contract Clinical Distributors (CCDs)) to plan and implement protocol specific CTM strategies from project start through package configuration, label design and development, GMP production campaigns, distribution to clinical sites, and study close-out.
·       Participate in design and implementation of Interactive Response Technology (IRT) systems for CTM management.
·       Coordinate CTM shipping and logistics activities including defining regional depot locations, management of shipments of CTM between storage depots and to clinical trial sites.
·       Review temperature logs for CTM distribution and storage and investigate temperature deviations according to SOP.
·       Monitor CTM inventory levels and collaborate with CMC team to define CTM manufacturing schedules which meet ongoing clinical trial product demand and in alignment with study start-up timelines.
·       Generate clinical demand forecasts, conduct supply availability analysis, and communicate results to key stakeholders.
·       Participate in review, development, and revision of department SOP.
·       Prepare annual and ad hoc budget projections for assigned projects.
·       Manage and mentor the supply chain specialists and monitor work to support supply of clinical studies.
 
QUALIFICATIONS
 
 ·      BA or BS in a Science or Logistics field or equivalent experience in Clinical Supply Chain
·       8+ years of experience working in the pharmaceutical industry.
·       6+ years of direct experience in clinical supply chain.
·       Proficiency in MS Office, including Word, Excel and PowerPoint
·       Knowledgeable and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s, and EU Annex 13, and EU CTR Annex 6.
·       Must be able to achieve deliverables with high precision.
·       Ability to work independently on projects within a team-oriented environment.
·       Innovative thinker with ability to solve complex problems. 
 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
 
COMPENSATION AND BENEFITS
 
The salary range for this position is $170,000 - $180,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
 
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
 
DISCLAIMER
 
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
 
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.
 
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.
 

Company

Day One Biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine. We are a unique company created to find and develop new therapies that meet the critical needs of people of all ages living with cancer – starting from the biology of childhood cancer. Our distinctive approach, together with our trusted network of pediatric oncology investigators, gives us an unparalleled ability to advance promising discoveries for patients of any age. We are ready to pursue the full potential of our therapies to improve the greatest number of lives as quickly as possible.

Company info
Website
Phone
1-650-484-0899
Location
2000 Sierra Point Parkway
Suite 501
Brisbane
CA
94005
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert