Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Clinical Project Manager III
N Waukegan Rd North Chicago, IL 60048 US
Posted: 06/10/2024
2024-06-10
2024-07-26
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 607684
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 86-96/hr
*Depending on experience
Primary responsibilities include the following:
• Conduct Health Economics and Outcomes Research projects under the supervision of the manager to support the Value Proposition to Regulators, Payers, Patients, Prescribers, and Policy-makers.
• Provides HEOR strategic expertise under the supervision of the manager, to support clinical trial design and efficient implementation of HEOR-related contributions (e.g., COAs).
• Applies extensive technical knowledge and experience to plan, execute, and interpret research and data collection activities.
• Independently identifies appropriate internal and external data resources and external experts to execute strategies and research activities led by HEOR.
• Assures alignment of research activities with Scientific Research Annual Plan; communicates any changes from plan in timely manner.
• Actively participates in cross-functional meetings (e.g., Pipeline Commercialization Model teams, Global Brand Teams) as subject matter expert for tactical discussions and proactively escalates foreseeable challenges/issues back to manager in a timely manner. Must be able to influence activities in a matrix organization.
• Develops and maintains effective cross-functional working relationships to assure effective teamwork with assigned teams.
• Monitors scientific, regulatory and reimbursement/access trends, events and policies for their potential to affect current research responsibilities in order to provide advice/guidance on best course of action.
• Ability to write study protocols with a high scientific standard and able to defend the protocol methodologies at the HEOR Protocol Review Committee review meetings.
• Experience in drafting of study reports, creation of presentation materials from study reports, ability to present scientific research to non-scientific audiences.
Candidate Requirements:
• M.S. or Ph.D. in health economics, health services research, pharmaceutical sciences, or related discipline.
• Experience in conducting and reviewing prospective/retrospective observational studies; economic modeling studies; familiarity with COA/PRO development, validation research and clinical trial implementation.
• Experience with industry cross-collaboration amongst functions involved in product launches (medical affairs, commercial/marketing, market access, clinical development, regulatory, etc.).
• Minimum 5+ years of full-time pharmaceutical industry or consulting experience in HEOR required.
• Experience in immunology is a plus.
What are the top 3-5 skills, experience or education required for this position:
• Experience in devising robust HEOR-related evidence-based strategies to inform early asset programs, enable differentiated product labeling and positioning, and help optimize reimbursement and access.
• Experience in conducting HEOR-related projects (e.g., real-world evidence [RWE] generation, economic modeling, perform literature reviews), including the ability to develop study protocols and output reports (e.g., manuscripts, posters, final reports, data on file).
• Ability to guide early clinical trial design with COA strategies in alignment with Regulatory, Commercial and Market Access objectives, with the ability to lead HEOR contributions to clinical trial documents (e.g., protocols, protocol manuals, clinical study reports).
• Strong communicator and ability to work semi-autonomously with strong reliability and sense of accountability for their work.
• Ability to manage multiple projects spanning pipeline and on-market indications across multiple indications in a fast-paced environment.
Daily Work Schedule Expectations: Average of 8 hours per day during typical business hours (8-5 CT), with infrequent need for earlier/later meetings to accommodate global geographies.
*CO/NYC candidates might not be considered
*Depending on experience
Primary responsibilities include the following:
• Conduct Health Economics and Outcomes Research projects under the supervision of the manager to support the Value Proposition to Regulators, Payers, Patients, Prescribers, and Policy-makers.
• Provides HEOR strategic expertise under the supervision of the manager, to support clinical trial design and efficient implementation of HEOR-related contributions (e.g., COAs).
• Applies extensive technical knowledge and experience to plan, execute, and interpret research and data collection activities.
• Independently identifies appropriate internal and external data resources and external experts to execute strategies and research activities led by HEOR.
• Assures alignment of research activities with Scientific Research Annual Plan; communicates any changes from plan in timely manner.
• Actively participates in cross-functional meetings (e.g., Pipeline Commercialization Model teams, Global Brand Teams) as subject matter expert for tactical discussions and proactively escalates foreseeable challenges/issues back to manager in a timely manner. Must be able to influence activities in a matrix organization.
• Develops and maintains effective cross-functional working relationships to assure effective teamwork with assigned teams.
• Monitors scientific, regulatory and reimbursement/access trends, events and policies for their potential to affect current research responsibilities in order to provide advice/guidance on best course of action.
• Ability to write study protocols with a high scientific standard and able to defend the protocol methodologies at the HEOR Protocol Review Committee review meetings.
• Experience in drafting of study reports, creation of presentation materials from study reports, ability to present scientific research to non-scientific audiences.
Candidate Requirements:
• M.S. or Ph.D. in health economics, health services research, pharmaceutical sciences, or related discipline.
• Experience in conducting and reviewing prospective/retrospective observational studies; economic modeling studies; familiarity with COA/PRO development, validation research and clinical trial implementation.
• Experience with industry cross-collaboration amongst functions involved in product launches (medical affairs, commercial/marketing, market access, clinical development, regulatory, etc.).
• Minimum 5+ years of full-time pharmaceutical industry or consulting experience in HEOR required.
• Experience in immunology is a plus.
What are the top 3-5 skills, experience or education required for this position:
• Experience in devising robust HEOR-related evidence-based strategies to inform early asset programs, enable differentiated product labeling and positioning, and help optimize reimbursement and access.
• Experience in conducting HEOR-related projects (e.g., real-world evidence [RWE] generation, economic modeling, perform literature reviews), including the ability to develop study protocols and output reports (e.g., manuscripts, posters, final reports, data on file).
• Ability to guide early clinical trial design with COA strategies in alignment with Regulatory, Commercial and Market Access objectives, with the ability to lead HEOR contributions to clinical trial documents (e.g., protocols, protocol manuals, clinical study reports).
• Strong communicator and ability to work semi-autonomously with strong reliability and sense of accountability for their work.
• Ability to manage multiple projects spanning pipeline and on-market indications across multiple indications in a fast-paced environment.
Daily Work Schedule Expectations: Average of 8 hours per day during typical business hours (8-5 CT), with infrequent need for earlier/later meetings to accommodate global geographies.
*CO/NYC candidates might not be considered
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