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nasdaq:hrtx www.herontx.com www.herontx.com Sep 9th, 2020 12:00AM Senior Medical Director, Clinical Research Open Clinical - Operations San Diego, California, United States San Diego CA USA Aug 25th, 2020 12:00AM <p>The Senior Medical Director, Clinical Research will be responsible for overseeing the company’s clinical development work for assigned programs and associated clinical trials. Establishes a clinical research development strategy for assigned programs and oversees clinical research planning including development of clinical trial protocols and data analysis strategies. Responsible for review, development and compilation of various clinical reports and regulatory filings. Develops functional plans for managing clinical research activities according to the strategic plan for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical research activities.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Develops clinical strategies including Phase 1 through 4 for assigned programs, and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines.</li> <li>Provides leadership and/or supervises project leaders for company’s development programs and works with Program Management to ensure all company functional areas are working together to complete timelines on time.</li> <li>Leads the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.</li> <li>Ensures that the relevant clinical development plans, protocols, reports, publications and regulatory documents are of the highest scientific, operational and ethical standards and are of highest quality, and completed on time.</li> <li>Collaborates with Clinical Operations, Biometrics and Data Management to ensure the adequate internal and external coordination of resources and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.  </li> <li>Collaborates with Clinical Operations to ensure the identification, recruitment and selection of appropriate clinical investigators and contract research organizations.</li> <li>Collaborate with Pharmacovigilance for ongoing safety monitoring and review and consultation regarding adverse events.</li> <li>Lead the planning and development of clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy.</li> <li>Review and consult on in-licensing opportunities for the company.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>MD required (oncologist preferred, surgical or anesthesiology background highly desirable) with a minimum of 5 years in a clinical or pharmaceutical setting.</li> <li>Background in Clinical Research; experience with CINV products preferred.</li> <li>5 years of experience leading clinical development activities in the pharmaceutical and/or biotech industry.</li> <li>Experience with Medical Affairs desirable, including launch preparation or support for a recently approved product, particularly in oncology or pain management areas.</li> <li>A successful track record of leading clinical development and registration of product candidates.</li> <li>Thorough knowledge of FDA requirements and good clinical practices.</li> <li>Ability to interpret and evaluate clinical data and synthesize and condense to inform Executive Management.</li> <li>Proven ability as a strong manager, mentor and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability and mutual respect.</li> <li>Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization.</li> <li>Possesses a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.</li> <li>Ability to operate in a cross-functional matrix environment.</li> <li>Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, the media, and management.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Sep 9th, 2020 02:17AM Sep 9th, 2020 02:17AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Sep 10th, 2020 12:00AM Senior Medical Director, Clinical Research Open Clinical - Operations San Diego, California, United States San Diego CA USA Aug 25th, 2020 12:00AM <p>The Senior Medical Director, Clinical Research will be responsible for overseeing the company’s clinical development work for assigned programs and associated clinical trials. Establishes a clinical research development strategy for assigned programs and oversees clinical research planning including development of clinical trial protocols and data analysis strategies. Responsible for review, development and compilation of various clinical reports and regulatory filings. Develops functional plans for managing clinical research activities according to the strategic plan for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical research activities.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Develops clinical strategies including Phase 1 through 4 for assigned programs, and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines.</li> <li>Provides leadership and/or supervises project leaders for company’s development programs and works with Program Management to ensure all company functional areas are working together to complete timelines on time.</li> <li>Leads the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.</li> <li>Ensures that the relevant clinical development plans, protocols, reports, publications and regulatory documents are of the highest scientific, operational and ethical standards and are of highest quality, and completed on time.</li> <li>Collaborates with Clinical Operations, Biometrics and Data Management to ensure the adequate internal and external coordination of resources and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.  </li> <li>Collaborates with Clinical Operations to ensure the identification, recruitment and selection of appropriate clinical investigators and contract research organizations.</li> <li>Collaborate with Pharmacovigilance for ongoing safety monitoring and review and consultation regarding adverse events.</li> <li>Lead the planning and development of clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy.</li> <li>Review and consult on in-licensing opportunities for the company.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>MD required (oncologist preferred, surgical or anesthesiology background highly desirable) with a minimum of 5 years in a clinical or pharmaceutical setting.</li> <li>Background in Clinical Research; experience with CINV products preferred.</li> <li>5 years of experience leading clinical development activities in the pharmaceutical and/or biotech industry.</li> <li>Experience with Medical Affairs desirable, including launch preparation or support for a recently approved product, particularly in oncology or pain management areas.</li> <li>A successful track record of leading clinical development and registration of product candidates.</li> <li>Thorough knowledge of FDA requirements and good clinical practices.</li> <li>Ability to interpret and evaluate clinical data and synthesize and condense to inform Executive Management.</li> <li>Proven ability as a strong manager, mentor and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability and mutual respect.</li> <li>Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization.</li> <li>Possesses a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.</li> <li>Ability to operate in a cross-functional matrix environment.</li> <li>Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, the media, and management.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Sep 10th, 2020 02:36AM Sep 10th, 2020 02:36AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Sep 8th, 2020 12:00AM Senior Medical Director, Clinical Research Open Clinical - Operations San Diego, California, United States San Diego CA USA Aug 25th, 2020 12:00AM <p>The Senior Medical Director, Clinical Research will be responsible for overseeing the company’s clinical development work for assigned programs and associated clinical trials. Establishes a clinical research development strategy for assigned programs and oversees clinical research planning including development of clinical trial protocols and data analysis strategies. Responsible for review, development and compilation of various clinical reports and regulatory filings. Develops functional plans for managing clinical research activities according to the strategic plan for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical research activities.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Develops clinical strategies including Phase 1 through 4 for assigned programs, and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines.</li> <li>Provides leadership and/or supervises project leaders for company’s development programs and works with Program Management to ensure all company functional areas are working together to complete timelines on time.</li> <li>Leads the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.</li> <li>Ensures that the relevant clinical development plans, protocols, reports, publications and regulatory documents are of the highest scientific, operational and ethical standards and are of highest quality, and completed on time.</li> <li>Collaborates with Clinical Operations, Biometrics and Data Management to ensure the adequate internal and external coordination of resources and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.  </li> <li>Collaborates with Clinical Operations to ensure the identification, recruitment and selection of appropriate clinical investigators and contract research organizations.</li> <li>Collaborate with Pharmacovigilance for ongoing safety monitoring and review and consultation regarding adverse events.</li> <li>Lead the planning and development of clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy.</li> <li>Review and consult on in-licensing opportunities for the company.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>MD required (oncologist preferred, surgical or anesthesiology background highly desirable) with a minimum of 5 years in a clinical or pharmaceutical setting.</li> <li>Background in Clinical Research; experience with CINV products preferred.</li> <li>5 years of experience leading clinical development activities in the pharmaceutical and/or biotech industry.</li> <li>Experience with Medical Affairs desirable, including launch preparation or support for a recently approved product, particularly in oncology or pain management areas.</li> <li>A successful track record of leading clinical development and registration of product candidates.</li> <li>Thorough knowledge of FDA requirements and good clinical practices.</li> <li>Ability to interpret and evaluate clinical data and synthesize and condense to inform Executive Management.</li> <li>Proven ability as a strong manager, mentor and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability and mutual respect.</li> <li>Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization.</li> <li>Possesses a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.</li> <li>Ability to operate in a cross-functional matrix environment.</li> <li>Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, the media, and management.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Sep 8th, 2020 03:31PM Sep 8th, 2020 03:31PM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Sep 11th, 2020 12:00AM Senior Medical Director, Clinical Research - CINV Open Clinical - Operations San Diego, California, United States San Diego CA USA Sep 10th, 2020 12:00AM <p>The Senior Medical Director, Clinical Research will be responsible for overseeing the company’s clinical development work for assigned programs and associated clinical trials. Establishes a clinical research development strategy for assigned programs and oversees clinical research planning including development of clinical trial protocols and data analysis strategies. Responsible for review, development and compilation of various clinical reports and regulatory filings. Develops functional plans for managing clinical research activities according to the strategic plan for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical research activities.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Develops clinical strategies including Phase 1 through 4 for assigned programs, and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines.</li> <li>Provides leadership and/or supervises project leaders for company’s development programs and works with Program Management to ensure all company functional areas are working together to complete timelines on time.</li> <li>Leads the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.</li> <li>Ensures that the relevant clinical development plans, protocols, reports, publications and regulatory documents are of the highest scientific, operational and ethical standards and are of highest quality, and completed on time.</li> <li>Collaborates with Clinical Operations, Biometrics and Data Management to ensure the adequate internal and external coordination of resources and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.  </li> <li>Collaborates with Clinical Operations to ensure the identification, recruitment and selection of appropriate clinical investigators and contract research organizations.</li> <li>Collaborate with Pharmacovigilance for ongoing safety monitoring and review and consultation regarding adverse events.</li> <li>Lead the planning and development of clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy.</li> <li>Review and consult on in-licensing opportunities for the company.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>MD required (oncologist preferred, surgical or anesthesiology background highly desirable) with a minimum of 5 years in a clinical or pharmaceutical setting.</li> <li>Background in Clinical Research; experience with CINV products preferred.</li> <li>5 years of experience leading clinical development activities in the pharmaceutical and/or biotech industry.</li> <li>Experience with Medical Affairs desirable, including launch preparation or support for a recently approved product, particularly in oncology or pain management areas.</li> <li>A successful track record of leading clinical development and registration of product candidates.</li> <li>Thorough knowledge of FDA requirements and good clinical practices.</li> <li>Ability to interpret and evaluate clinical data and synthesize and condense to inform Executive Management.</li> <li>Proven ability as a strong manager, mentor and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability and mutual respect.</li> <li>Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization.</li> <li>Possesses a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.</li> <li>Ability to operate in a cross-functional matrix environment.</li> <li>Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, the media, and management.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Sep 11th, 2020 02:23AM Sep 11th, 2020 02:23AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Oct 26th, 2020 12:00AM Area Business Manager - Alabama Open Sales Oncology Sep 17th, 2020 12:00AM <p>The ABM is the primary customer contact within an assigned territory responsible for promoting oncology supportive care products in oncology clinics and hospitals and for launching and selling the Company’s lead product candidate, HTX-011, a dual acting post-operative pain analgesic, in the ambulatory surgery center (ASC) market with a specific focus on pain management.  Key responsibilities include developing and implementing strategies for introducing new products, maintaining and growing the business in assigned accounts through execution of marketing strategies, communicating reimbursement processes, pulling through account level GPO contracts, promoting thought-leader and advocate development, and building strong relationships with other key personnel to drive product sales. This includes engagement of targeted oncologists and surgeons along with ancillary staff, willingness/ or experience working in Operating Room (OR) settings to educate customers on proper use of products during procedures/ cases, working with reimbursement and office management to ensure product reimbursement, in-servicing all staff to ensure safe and appropriate drug administration.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Achieve or exceed sales objectives in assigned geography that aligns to the overall commercial brand strategy. Analyze territory and account trends to develop and implement strategically targeted account-specific territory business plans that reflect an in-depth understanding of local market forces.</li> <li>Establish and maintain professional relationships with targeted opinion leaders (e.g. oncologists, nurses, surgeons, anesthesiologists, pharmacists, and other critical medical staff) for both oncology/supportive care and pain management products.</li> <li>Ensure Heron products are on formulary when applicable as well as embedded within EMR systems, on appropriate protocols and standing orders to ensure product accessibility and pull-through.</li> <li>Maintain an updated working knowledge of Heron products, relevant disease states, and competitor products in order to provide comprehensive clinical knowledge to customer contacts.</li> <li>Collaborate cross functionally to strategize, implement and manage contracts, and identify emerging trends that help shape future contracts and alternatives to the business model. Understand national and local reimbursement policies for the assigned region; communicate changes proactively to key accounts and to internal stakeholders.</li> <li>Develop and implement special programs within territory to maximize sales opportunities (e.g. reimbursement tools, speaker programs, symposia, etc.) partnering with cross-functional teams as appropriate.</li> <li>Lead cross-functional teams to develop long-term relationships with key accounts and stakeholders within the marketplace.</li> <li>Complete assigned administrative tasks, including customer records, in a timely, accurate, legible, and organized manner.</li> <li>Ensure compliance with corporate policies and procedures and applicable FDA and OIG legal standards and requirements as well as PhRMA Code.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>A. or B.S. degree in relevant field or equivalent experience required.</li> <li>Minimum of 3 years of sales or account management experience in the pharmaceutical or medical device industry. Experience in the assigned territory/accounts highly preferred.</li> <li>Demonstrated superior selling skills and proven sales performance track record of meeting or exceeding goals. Experience in contract implementation and management preferred.</li> <li>Demonstrated strong business skills to understand and analyze business and market drivers, and develop, execute and adjust business plans.</li> <li>Demonstrated skills at building and maintaining strong professional relationships with key customers, office staff and other influential stakeholders. Experience working alongside physicians and staff in the operating room preferred.  Willingness to learn the operating room selling environment including but not limited to assisting with product demonstrations in operating room.</li> <li>Demonstrated experience developing relationships with hospital pharmacies and getting on P&T including experience building a coalition across different groups to get a product on formulary.</li> <li>Demonstrated understanding of EMR, CPOE, ASC and HOPD systems.</li> <li>Excellent communication and interpersonal skills; self-motivated with a sense of urgency, well-organized, strong problem-solving abilities.</li> <li>Demonstrated in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position Heron products compliantly versus competition.</li> <li>Ability to understand and articulate the oncology buy and bill & ASC bundled payment environment including the billing and reimbursement process preferred.</li> <li>Knowledge and experience of legal and compliance framework related to the pharma/biotech industries preferred.</li> <li>Ability to work effectively in a team-oriented, cross-functional environment while maintaining an entrepreneurial spirit on a consistent basis. Foster team effectiveness and accomplishments of joint goals by sharing knowledge, experience and information.</li> <li>Familiarity with Qlik and Veeva platforms preferred.</li> <li>Candidates must satisfy reasonable credentialing requirements, including, but not limited to vaccinations and background checks, where applicable.</li> <li>Must be willing to travel by car or plane as needed to visit customers, attend conferences, or corporate meetings. Must possess a valid motor vehicle operator’s license in good standing.  Must be available to work in the evenings and weekends, as required.  Position will require up to 70% travel.</li> </ul> <p><em>The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Oct 26th, 2020 03:38AM Oct 26th, 2020 03:38AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Oct 24th, 2020 12:00AM Area Business Manager - Alabama Open Sales Oncology Sep 17th, 2020 12:00AM <p>The ABM is the primary customer contact within an assigned territory responsible for promoting oncology supportive care products in oncology clinics and hospitals and for launching and selling the Company’s lead product candidate, HTX-011, a dual acting post-operative pain analgesic, in the ambulatory surgery center (ASC) market with a specific focus on pain management.  Key responsibilities include developing and implementing strategies for introducing new products, maintaining and growing the business in assigned accounts through execution of marketing strategies, communicating reimbursement processes, pulling through account level GPO contracts, promoting thought-leader and advocate development, and building strong relationships with other key personnel to drive product sales. This includes engagement of targeted oncologists and surgeons along with ancillary staff, willingness/ or experience working in Operating Room (OR) settings to educate customers on proper use of products during procedures/ cases, working with reimbursement and office management to ensure product reimbursement, in-servicing all staff to ensure safe and appropriate drug administration.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Achieve or exceed sales objectives in assigned geography that aligns to the overall commercial brand strategy. Analyze territory and account trends to develop and implement strategically targeted account-specific territory business plans that reflect an in-depth understanding of local market forces.</li> <li>Establish and maintain professional relationships with targeted opinion leaders (e.g. oncologists, nurses, surgeons, anesthesiologists, pharmacists, and other critical medical staff) for both oncology/supportive care and pain management products.</li> <li>Ensure Heron products are on formulary when applicable as well as embedded within EMR systems, on appropriate protocols and standing orders to ensure product accessibility and pull-through.</li> <li>Maintain an updated working knowledge of Heron products, relevant disease states, and competitor products in order to provide comprehensive clinical knowledge to customer contacts.</li> <li>Collaborate cross functionally to strategize, implement and manage contracts, and identify emerging trends that help shape future contracts and alternatives to the business model. Understand national and local reimbursement policies for the assigned region; communicate changes proactively to key accounts and to internal stakeholders.</li> <li>Develop and implement special programs within territory to maximize sales opportunities (e.g. reimbursement tools, speaker programs, symposia, etc.) partnering with cross-functional teams as appropriate.</li> <li>Lead cross-functional teams to develop long-term relationships with key accounts and stakeholders within the marketplace.</li> <li>Complete assigned administrative tasks, including customer records, in a timely, accurate, legible, and organized manner.</li> <li>Ensure compliance with corporate policies and procedures and applicable FDA and OIG legal standards and requirements as well as PhRMA Code.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>A. or B.S. degree in relevant field or equivalent experience required.</li> <li>Minimum of 3 years of sales or account management experience in the pharmaceutical or medical device industry. Experience in the assigned territory/accounts highly preferred.</li> <li>Demonstrated superior selling skills and proven sales performance track record of meeting or exceeding goals. Experience in contract implementation and management preferred.</li> <li>Demonstrated strong business skills to understand and analyze business and market drivers, and develop, execute and adjust business plans.</li> <li>Demonstrated skills at building and maintaining strong professional relationships with key customers, office staff and other influential stakeholders. Experience working alongside physicians and staff in the operating room preferred.  Willingness to learn the operating room selling environment including but not limited to assisting with product demonstrations in operating room.</li> <li>Demonstrated experience developing relationships with hospital pharmacies and getting on P&T including experience building a coalition across different groups to get a product on formulary.</li> <li>Demonstrated understanding of EMR, CPOE, ASC and HOPD systems.</li> <li>Excellent communication and interpersonal skills; self-motivated with a sense of urgency, well-organized, strong problem-solving abilities.</li> <li>Demonstrated in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position Heron products compliantly versus competition.</li> <li>Ability to understand and articulate the oncology buy and bill & ASC bundled payment environment including the billing and reimbursement process preferred.</li> <li>Knowledge and experience of legal and compliance framework related to the pharma/biotech industries preferred.</li> <li>Ability to work effectively in a team-oriented, cross-functional environment while maintaining an entrepreneurial spirit on a consistent basis. Foster team effectiveness and accomplishments of joint goals by sharing knowledge, experience and information.</li> <li>Familiarity with Qlik and Veeva platforms preferred.</li> <li>Candidates must satisfy reasonable credentialing requirements, including, but not limited to vaccinations and background checks, where applicable.</li> <li>Must be willing to travel by car or plane as needed to visit customers, attend conferences, or corporate meetings. Must possess a valid motor vehicle operator’s license in good standing.  Must be available to work in the evenings and weekends, as required.  Position will require up to 70% travel.</li> </ul> <p><em>The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Oct 24th, 2020 01:58AM Oct 24th, 2020 01:58AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Oct 22nd, 2020 12:00AM Area Business Manager - Alabama Open Sales Oncology Sep 17th, 2020 12:00AM <p>The ABM is the primary customer contact within an assigned territory responsible for promoting oncology supportive care products in oncology clinics and hospitals and for launching and selling the Company’s lead product candidate, HTX-011, a dual acting post-operative pain analgesic, in the ambulatory surgery center (ASC) market with a specific focus on pain management.  Key responsibilities include developing and implementing strategies for introducing new products, maintaining and growing the business in assigned accounts through execution of marketing strategies, communicating reimbursement processes, pulling through account level GPO contracts, promoting thought-leader and advocate development, and building strong relationships with other key personnel to drive product sales. This includes engagement of targeted oncologists and surgeons along with ancillary staff, willingness/ or experience working in Operating Room (OR) settings to educate customers on proper use of products during procedures/ cases, working with reimbursement and office management to ensure product reimbursement, in-servicing all staff to ensure safe and appropriate drug administration.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Achieve or exceed sales objectives in assigned geography that aligns to the overall commercial brand strategy. Analyze territory and account trends to develop and implement strategically targeted account-specific territory business plans that reflect an in-depth understanding of local market forces.</li> <li>Establish and maintain professional relationships with targeted opinion leaders (e.g. oncologists, nurses, surgeons, anesthesiologists, pharmacists, and other critical medical staff) for both oncology/supportive care and pain management products.</li> <li>Ensure Heron products are on formulary when applicable as well as embedded within EMR systems, on appropriate protocols and standing orders to ensure product accessibility and pull-through.</li> <li>Maintain an updated working knowledge of Heron products, relevant disease states, and competitor products in order to provide comprehensive clinical knowledge to customer contacts.</li> <li>Collaborate cross functionally to strategize, implement and manage contracts, and identify emerging trends that help shape future contracts and alternatives to the business model. Understand national and local reimbursement policies for the assigned region; communicate changes proactively to key accounts and to internal stakeholders.</li> <li>Develop and implement special programs within territory to maximize sales opportunities (e.g. reimbursement tools, speaker programs, symposia, etc.) partnering with cross-functional teams as appropriate.</li> <li>Lead cross-functional teams to develop long-term relationships with key accounts and stakeholders within the marketplace.</li> <li>Complete assigned administrative tasks, including customer records, in a timely, accurate, legible, and organized manner.</li> <li>Ensure compliance with corporate policies and procedures and applicable FDA and OIG legal standards and requirements as well as PhRMA Code.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>A. or B.S. degree in relevant field or equivalent experience required.</li> <li>Minimum of 3 years of sales or account management experience in the pharmaceutical or medical device industry. Experience in the assigned territory/accounts highly preferred.</li> <li>Demonstrated superior selling skills and proven sales performance track record of meeting or exceeding goals. Experience in contract implementation and management preferred.</li> <li>Demonstrated strong business skills to understand and analyze business and market drivers, and develop, execute and adjust business plans.</li> <li>Demonstrated skills at building and maintaining strong professional relationships with key customers, office staff and other influential stakeholders. Experience working alongside physicians and staff in the operating room preferred.  Willingness to learn the operating room selling environment including but not limited to assisting with product demonstrations in operating room.</li> <li>Demonstrated experience developing relationships with hospital pharmacies and getting on P&T including experience building a coalition across different groups to get a product on formulary.</li> <li>Demonstrated understanding of EMR, CPOE, ASC and HOPD systems.</li> <li>Excellent communication and interpersonal skills; self-motivated with a sense of urgency, well-organized, strong problem-solving abilities.</li> <li>Demonstrated in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position Heron products compliantly versus competition.</li> <li>Ability to understand and articulate the oncology buy and bill & ASC bundled payment environment including the billing and reimbursement process preferred.</li> <li>Knowledge and experience of legal and compliance framework related to the pharma/biotech industries preferred.</li> <li>Ability to work effectively in a team-oriented, cross-functional environment while maintaining an entrepreneurial spirit on a consistent basis. Foster team effectiveness and accomplishments of joint goals by sharing knowledge, experience and information.</li> <li>Familiarity with Qlik and Veeva platforms preferred.</li> <li>Candidates must satisfy reasonable credentialing requirements, including, but not limited to vaccinations and background checks, where applicable.</li> <li>Must be willing to travel by car or plane as needed to visit customers, attend conferences, or corporate meetings. Must possess a valid motor vehicle operator’s license in good standing.  Must be available to work in the evenings and weekends, as required.  Position will require up to 70% travel.</li> </ul> <p><em>The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Oct 22nd, 2020 02:48AM Oct 22nd, 2020 02:48AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Sep 13th, 2020 12:00AM Senior Medical Director, Clinical Research - CINV Open Clinical - Operations San Diego, California, United States San Diego CA USA Sep 10th, 2020 12:00AM <p>The Senior Medical Director, Clinical Research will be responsible for overseeing the company’s clinical development work for assigned programs and associated clinical trials. Establishes a clinical research development strategy for assigned programs and oversees clinical research planning including development of clinical trial protocols and data analysis strategies. Responsible for review, development and compilation of various clinical reports and regulatory filings. Develops functional plans for managing clinical research activities according to the strategic plan for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical research activities.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Develops clinical strategies including Phase 1 through 4 for assigned programs, and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines.</li> <li>Provides leadership and/or supervises project leaders for company’s development programs and works with Program Management to ensure all company functional areas are working together to complete timelines on time.</li> <li>Leads the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.</li> <li>Ensures that the relevant clinical development plans, protocols, reports, publications and regulatory documents are of the highest scientific, operational and ethical standards and are of highest quality, and completed on time.</li> <li>Collaborates with Clinical Operations, Biometrics and Data Management to ensure the adequate internal and external coordination of resources and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.  </li> <li>Collaborates with Clinical Operations to ensure the identification, recruitment and selection of appropriate clinical investigators and contract research organizations.</li> <li>Collaborate with Pharmacovigilance for ongoing safety monitoring and review and consultation regarding adverse events.</li> <li>Lead the planning and development of clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy.</li> <li>Review and consult on in-licensing opportunities for the company.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>MD required (oncologist preferred, surgical or anesthesiology background highly desirable) with a minimum of 5 years in a clinical or pharmaceutical setting.</li> <li>Background in Clinical Research; experience with CINV products preferred.</li> <li>5 years of experience leading clinical development activities in the pharmaceutical and/or biotech industry.</li> <li>Experience with Medical Affairs desirable, including launch preparation or support for a recently approved product, particularly in oncology or pain management areas.</li> <li>A successful track record of leading clinical development and registration of product candidates.</li> <li>Thorough knowledge of FDA requirements and good clinical practices.</li> <li>Ability to interpret and evaluate clinical data and synthesize and condense to inform Executive Management.</li> <li>Proven ability as a strong manager, mentor and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability and mutual respect.</li> <li>Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization.</li> <li>Possesses a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.</li> <li>Ability to operate in a cross-functional matrix environment.</li> <li>Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, the media, and management.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Sep 13th, 2020 03:05AM Sep 13th, 2020 03:05AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Oct 25th, 2020 12:00AM Manager / Senior Manager, Quality Assurance Open Quality Assurance San Diego, California, United States San Diego CA USA Oct 8th, 2020 12:00AM <p>Perform detailed documentation review of clinical and commercial contract manufacturing production records for GMP compliance and execution according to the approved master batch/device records. Determination and approval of QA lot disposition decisions. Review and approve Heron Quality System documents, as well as review or collection of data for regulatory submissions and IND/NDA maintenance requirements (APR, NDA annual report, product complaints, etc.). Ensure GMP record organization and retrievable storage of approved documents and records.</p> <h3><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></h3> <ul> <li>Review and approve master batch records for contract manufacturing organization excipients, drug product, drug/device combination product, and clinical labeling operations.</li> <li>Review and approve change request to ensure the proposed changes are clearly described, justified, and validated or verified as completed per the pre-approved change request. </li> <li>GMP/QA review of QC stability and test method protocols and reports.</li> <li>Perform technical assessments and QA approval of deviations, investigations, and corrective actions.</li> <li>Lead GMP investigations for proper closure and identification of corrective actions.</li> <li>Review of executed production records and QC testing results to determine QA disposition decisions (API, excipients, drug product, drug/device combination final products, training kits, and clinical labeling batches).</li> <li>Organize/Archive executed batch record documentation, manufacturing records, analytical data documentation, labeling and packaging records.</li> <li>Review and disposition of open and blinded clinical labeling production lots.</li> <li>Revise and/or approve standard operating procedures and other controlled documents as necessary. </li> <li>Perform product Complaint Investigations.</li> <li>Review data for and/or sections of regulatory submissions. </li> <li>Provide annual product quality review and NOA annual report data collection and analysis.</li> <li>Communicate/collaborate with Heron Therapeutics Subject Matter Experts and contract manufacturing organizations on quality related issues supporting Heron QA.</li> <li>Maintain QA Operations logs, databases, and generate Quality metrics.</li> <li>Support or perform internal and supplier qualification audits, as requested.</li> <li>Contributing work necessary for regulatory inspections.</li> <li>Review of R&O documents as requested. </li> </ul> <h3><strong><u>REQUIREMENTS:</u></strong></h3> <ul> <li>Minimum BA/BS in Chemistry, Life Sciences (Biology, Pharmacology, etc.), or Chemical Engineering.</li> <li>5+ years of experience in the pharmaceutical or biopharmaceutical industry.</li> <li>Demonstrated understanding of cGMPs and ability to practically apply them internally and with CMOs.</li> <li>Good understanding of Quality principles, industry practices, and US and EU standards with demonstrated ability to apply these to GXP operations internally and at CMOs and Suppliers. </li> <li>Understanding of pharmaceutical formulation, aseptic filling, commercial, and clinical labeling and packaging.</li> <li>Independent decision making with a high degree of initiative. </li> <li>Able to correctly communicate with verbal and written communication and with the ability to influence others and lead complex QA projects.</li> <li>Motivated self-starter; detail, records, and results-oriented.</li> <li>Well organized and efficient with ability to manage multiple priorities.</li> <li>Innovative thinker and problem solver with ­­­­­integrity. </li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> Oct 25th, 2020 10:38AM Oct 25th, 2020 10:38AM Heron Therapeutics Pharmaceuticals & Biotechnology
nasdaq:hrtx www.herontx.com www.herontx.com Sep 15th, 2020 12:00AM Senior Medical Director, Clinical Research - CINV Open Clinical - Operations San Diego, California, United States San Diego CA USA Sep 10th, 2020 12:00AM <p>The Senior Medical Director, Clinical Research will be responsible for overseeing the company’s clinical development work for assigned programs and associated clinical trials. Establishes a clinical research development strategy for assigned programs and oversees clinical research planning including development of clinical trial protocols and data analysis strategies. Responsible for review, development and compilation of various clinical reports and regulatory filings. Develops functional plans for managing clinical research activities according to the strategic plan for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical research activities.</p> <p><strong><u>ESSENTIAL DUTIES & RESPONSIBILITIES:</u></strong></p> <ul> <li>Develops clinical strategies including Phase 1 through 4 for assigned programs, and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines.</li> <li>Provides leadership and/or supervises project leaders for company’s development programs and works with Program Management to ensure all company functional areas are working together to complete timelines on time.</li> <li>Leads the strategic definition and tactical development of clinical trials programs, including protocol writing, interpretation of clinical data, and literature reviews.</li> <li>Ensures that the relevant clinical development plans, protocols, reports, publications and regulatory documents are of the highest scientific, operational and ethical standards and are of highest quality, and completed on time.</li> <li>Collaborates with Clinical Operations, Biometrics and Data Management to ensure the adequate internal and external coordination of resources and that all people, systems, processes and materials required for clinical trials are available and appropriately prepared.  </li> <li>Collaborates with Clinical Operations to ensure the identification, recruitment and selection of appropriate clinical investigators and contract research organizations.</li> <li>Collaborate with Pharmacovigilance for ongoing safety monitoring and review and consultation regarding adverse events.</li> <li>Lead the planning and development of clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy.</li> <li>Review and consult on in-licensing opportunities for the company.</li> </ul> <p><strong><u>REQUIREMENTS:</u></strong></p> <ul> <li>MD required (oncologist preferred, surgical or anesthesiology background highly desirable) with a minimum of 5 years in a clinical or pharmaceutical setting.</li> <li>Background in Clinical Research; experience with CINV products preferred.</li> <li>5 years of experience leading clinical development activities in the pharmaceutical and/or biotech industry.</li> <li>Experience with Medical Affairs desirable, including launch preparation or support for a recently approved product, particularly in oncology or pain management areas.</li> <li>A successful track record of leading clinical development and registration of product candidates.</li> <li>Thorough knowledge of FDA requirements and good clinical practices.</li> <li>Ability to interpret and evaluate clinical data and synthesize and condense to inform Executive Management.</li> <li>Proven ability as a strong manager, mentor and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability and mutual respect.</li> <li>Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization.</li> <li>Possesses a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.</li> <li>Ability to operate in a cross-functional matrix environment.</li> <li>Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, the media, and management.</li> <li>Ability to travel up to 25% of the time.</li> </ul> <p><em>The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.</em></p> <p><em>Heron Therapeutics is an EEO/AA/Disability/Veterans Employer.</em></p> <p> </p> Sep 15th, 2020 04:21AM Sep 15th, 2020 04:21AM Heron Therapeutics Pharmaceuticals & Biotechnology

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