Sr Clinical Supplies Manager - EXELIXIS
Valley Forge, PA
About the Job
SUMMARY/JOB PURPOSE:The Senior Clinical Supplies Manager oversees all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites.Essential Duties And Responsibilities:Lead effort for clinical supply management functionality
Monitor and manage clinical supply activities through IRT from study start-up through study closure
Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO’s for assigned studies, ensuring the project timeline is met or exceeded
Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases
In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan
Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials
Work cross-functionally to develop IRT to develop specifications and perform UAT
Design and/or review label text to meet product requirements and ensure compliance with US and international regulations
Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners
Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors
Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness
Utilize appropriate software and IT systems to effectively manage key project activities
Supervisory Responsibilities:NoneEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education/Experience:BS/BA degree in related discipline and a minimum of nine years of related experience; or, MS/MA degree in related discipline and a minimum of seven years of related experience; or, Equivalent combination of education and experience
Certification in assigned areas is a plus
Experience/The Ideal for Successful Entry into Job:Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution
Clinical Supply management experience using contract manufacturing companies strongly preferred
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRSKnowledge/Skills:Willingness to work in a fast paced, evolving environment.Knowledge of GMP batch record development, review, and approval processes
Knowledge of Interactive Voice/Web response systems for use in clinical studies
Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.Working knowledge of GMP/GCP/GLP regulations required
Excellent project management and communication skills.JOB COMPLEXITY:Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways
May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Networks with key contacts outside own area of expertise.Working Conditions:20% travel to vendor sites, team meetings, and/or other offices.If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!Our compensation reflects the cost of labor across several U.S
geographic markets, and we pay differently based on those defined markets
The base pay range for this position is $138,000 - $196,000 annually
The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location
The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.SummaryLocation: King of Prussia, PAType: Full time
Monitor and manage clinical supply activities through IRT from study start-up through study closure
Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO’s for assigned studies, ensuring the project timeline is met or exceeded
Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases
In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan
Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials
Work cross-functionally to develop IRT to develop specifications and perform UAT
Design and/or review label text to meet product requirements and ensure compliance with US and international regulations
Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners
Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors
Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness
Utilize appropriate software and IT systems to effectively manage key project activities
Supervisory Responsibilities:NoneEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education/Experience:BS/BA degree in related discipline and a minimum of nine years of related experience; or, MS/MA degree in related discipline and a minimum of seven years of related experience; or, Equivalent combination of education and experience
Certification in assigned areas is a plus
Experience/The Ideal for Successful Entry into Job:Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution
Clinical Supply management experience using contract manufacturing companies strongly preferred
Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRSKnowledge/Skills:Willingness to work in a fast paced, evolving environment.Knowledge of GMP batch record development, review, and approval processes
Knowledge of Interactive Voice/Web response systems for use in clinical studies
Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.Working knowledge of GMP/GCP/GLP regulations required
Excellent project management and communication skills.JOB COMPLEXITY:Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways
May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Networks with key contacts outside own area of expertise.Working Conditions:20% travel to vendor sites, team meetings, and/or other offices.If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!Our compensation reflects the cost of labor across several U.S
geographic markets, and we pay differently based on those defined markets
The base pay range for this position is $138,000 - $196,000 annually
The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location
The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan
Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.SummaryLocation: King of Prussia, PAType: Full time
Source : EXELIXIS