Sumitomo Pharma
Director, Medical Affairs Strategy (Hematology/Oncology)
Sumitomo Pharma, Lansing, Michigan, United States, 48900
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
Job Overview
The Director, Medical Affairs Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy.
In this role, individuals are responsible for Medical Affairs strategic direction and management for Pipeline Hematology/Oncology asset(s), leading the Medical Affair planning for both internal company programs and external facing interactions. The job will oversee the management peri-, pre-, and post-launch activities related to Medical Affairs function.
This individual will lead program coordination with Clinical Development leadership to ensure alignment between Medical Affairs, Advocacy, Translational Medicine, and Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also collaborate with company outreach and patient advocacy efforts to ensure that Medical Affairs activities align with these patient focused programs.
Job Duties and Responsibilities
Ensure leadership and alignment of all Medical Affairs activities and budgets for Pipeline Hematology/Oncology Product(s) within SMPA.
Manage the development of Medical Affairs strategic plans and scientific platforms in support of Pipeline Hematology/Oncology Product(s).
Represent the Oncology Products Medical Strategy Team within the Medical Affairs leadership and executive leadership teams, including presentations at the Global Medical Affair Monthly and Global Product Development Monthly Meetings.
Serve as Subject Matter Expert within Medical Affairs Team provide medical training, evaluation, motivation, and control of activities in alignment with the company’s corporate strategies and objectives.
Lead cross-functional medical alignment with the US Field Medical team, Medical Communications & Operations, Japan medical affairs colleagues, RWE (Real World Evidence) & HEOR (Health Economics and Outcomes Research) for SMPA and ex-US colleagues (Basel and Canada).
Develop and direct the implementation of plans that will be executed through multi-modal medical education channels, including publications, presentations, congresses, advisory boards, CME (Continuing Medical Education), medical symposia, and other channels in support of combination therapy commercialization.
Manage the development and implementation of detailed scientific Publication Plans, Medical Advisory Boards, and Patient Advisory Boards upon review and approval of Legal and Compliance process.
Represent the Medical Affairs department on the lifecycle team to provide medical affairs input to Clinical Development and Clinical Operation’s needs.
Proactively seek and create relationships directly with key opinion leaders, prominent clinical investigators, and scientific advisory groups in designated therapeutic area, providing them with credible, fair, balanced, scientific information about product development, research activities, and therapy(s)
Upon submission of NDA (New Drug Application) and approval of the VP of Medical Affairs, work closely with the commercial organization to bring the medical and pharmacoeconomic perspectives to commercial strategies and tactics, aligning with Marketing & Market Access to collaborate.
Partner with the Clinical Development organization for ongoing and post-marketing clinical development activities.
Provide detailed and compliant medical review and approval of external resources, communications, and publications – ensuring medical accuracy, relevance, and fair-balance.
Define and attend relevant medical and scientific conferences to help coordinate medical affairs activities, as well as support speakers and presenters, ensure the success of publication/communication goals, and participate in the collection and reporting of competitive intelligence within company guidelines.
Provide input into budget and long-term Medical Education programming or Medical Sponsorships.
Develop Areas of Research Interest that supports a robust and active Investigator Initiated Study program.
Ensure that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
Serves as Medical Affairs Lead on select therapeutics topics, and provides input into developing scientific messages,
Provide feedback on Medical Information response documents.
Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of medical activities - up to 30% travel.
Key Core Competencies
Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees.
Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company.
Must have excellent interpersonal skills, with experience in conflict management and relationship building.
Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions.
Mentorship attitude with the capability to work cross-functionally with peers and other colleagues, as appropriate.
Capable of translating broad corporate objectives into actionable medical and scientific strategies.
Proven record of accomplishment of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements.
Experience representing a broad range of stakeholders in the development and communication of medical activities and plans.
Education and Experience
Advanced degree in medical science (MD, PharmD, PhD) or equivalent professional hematology/oncology clinical experience; with knowledge of the acute myeloid leukemia (AML) landscape is required.
8-10+ years of relevant professional experience in biotech, pharmaceutical industry, or related healthcare experience.
Medical Affairs and strategic planning experience within a matrix team environment is considered a plus.
Strong organizational skills, and familiarity working on PCs and the Microsoft Office Suite.
The base salary range for this role is $187,800 to $234,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data
: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance
:Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements
: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.
Our
Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people
worldwide
Our
Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and
ideas
Job Overview
The Director, Medical Affairs Strategy (Hematology/Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director, Medical Affairs Strategy.
In this role, individuals are responsible for Medical Affairs strategic direction and management for Pipeline Hematology/Oncology asset(s), leading the Medical Affair planning for both internal company programs and external facing interactions. The job will oversee the management peri-, pre-, and post-launch activities related to Medical Affairs function.
This individual will lead program coordination with Clinical Development leadership to ensure alignment between Medical Affairs, Advocacy, Translational Medicine, and Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also collaborate with company outreach and patient advocacy efforts to ensure that Medical Affairs activities align with these patient focused programs.
Job Duties and Responsibilities
Ensure leadership and alignment of all Medical Affairs activities and budgets for Pipeline Hematology/Oncology Product(s) within SMPA.
Manage the development of Medical Affairs strategic plans and scientific platforms in support of Pipeline Hematology/Oncology Product(s).
Represent the Oncology Products Medical Strategy Team within the Medical Affairs leadership and executive leadership teams, including presentations at the Global Medical Affair Monthly and Global Product Development Monthly Meetings.
Serve as Subject Matter Expert within Medical Affairs Team provide medical training, evaluation, motivation, and control of activities in alignment with the company’s corporate strategies and objectives.
Lead cross-functional medical alignment with the US Field Medical team, Medical Communications & Operations, Japan medical affairs colleagues, RWE (Real World Evidence) & HEOR (Health Economics and Outcomes Research) for SMPA and ex-US colleagues (Basel and Canada).
Develop and direct the implementation of plans that will be executed through multi-modal medical education channels, including publications, presentations, congresses, advisory boards, CME (Continuing Medical Education), medical symposia, and other channels in support of combination therapy commercialization.
Manage the development and implementation of detailed scientific Publication Plans, Medical Advisory Boards, and Patient Advisory Boards upon review and approval of Legal and Compliance process.
Represent the Medical Affairs department on the lifecycle team to provide medical affairs input to Clinical Development and Clinical Operation’s needs.
Proactively seek and create relationships directly with key opinion leaders, prominent clinical investigators, and scientific advisory groups in designated therapeutic area, providing them with credible, fair, balanced, scientific information about product development, research activities, and therapy(s)
Upon submission of NDA (New Drug Application) and approval of the VP of Medical Affairs, work closely with the commercial organization to bring the medical and pharmacoeconomic perspectives to commercial strategies and tactics, aligning with Marketing & Market Access to collaborate.
Partner with the Clinical Development organization for ongoing and post-marketing clinical development activities.
Provide detailed and compliant medical review and approval of external resources, communications, and publications – ensuring medical accuracy, relevance, and fair-balance.
Define and attend relevant medical and scientific conferences to help coordinate medical affairs activities, as well as support speakers and presenters, ensure the success of publication/communication goals, and participate in the collection and reporting of competitive intelligence within company guidelines.
Provide input into budget and long-term Medical Education programming or Medical Sponsorships.
Develop Areas of Research Interest that supports a robust and active Investigator Initiated Study program.
Ensure that all interactions and activities in the US adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
Serves as Medical Affairs Lead on select therapeutics topics, and provides input into developing scientific messages,
Provide feedback on Medical Information response documents.
Ability to travel (domestic and some international) to attend scientific congresses, participate in internal meetings, and meet key stakeholders in the development of medical activities - up to 30% travel.
Key Core Competencies
Excellent verbal and written communication skills, as the position will interface with key opinion leaders and a wide range of internal employees.
Ability to effectively communicate, collaborate and deliver excellent work in a fast-paced, and rapidly changing dynamic company.
Must have excellent interpersonal skills, with experience in conflict management and relationship building.
Ability to analyze complex issues critically and develop realistic and accomplishable plans and solutions.
Mentorship attitude with the capability to work cross-functionally with peers and other colleagues, as appropriate.
Capable of translating broad corporate objectives into actionable medical and scientific strategies.
Proven record of accomplishment of detailed, medically accurate, and scientifically relevant writing and review skills in line with compliance requirements.
Experience representing a broad range of stakeholders in the development and communication of medical activities and plans.
Education and Experience
Advanced degree in medical science (MD, PharmD, PhD) or equivalent professional hematology/oncology clinical experience; with knowledge of the acute myeloid leukemia (AML) landscape is required.
8-10+ years of relevant professional experience in biotech, pharmaceutical industry, or related healthcare experience.
Medical Affairs and strategic planning experience within a matrix team environment is considered a plus.
Strong organizational skills, and familiarity working on PCs and the Microsoft Office Suite.
The base salary range for this role is $187,800 to $234,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data
: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance
:Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements
: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.
Our
Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people
worldwide
Our
Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and
ideas