Medical Director jobs at Novo Nordisk

A clinical-stage biopharmaceutical company focused on developing innovative therapies in oncology and immunology. The organization is committed to advancing science and improving patient outcomes through a robust pipeline and strategic medical engagement. Position Summary The MSL/Field Medical Director serves as a key field-based representative of the Medical Affairs team, responsible for scientific exchange, clinical education, and research support across a defined geographic territory. This role is non-promotional and centers on building peer-to-peer relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), and clinical investigators. The FMD plays a critical role in executing medical strategy, gathering field insights, and supporting clinical development initiatives. Key Responsibilities Scientific Engagement & External Stakeholder Support Serve as the primary clinical/scientific resource for HCPs and KOLs within the assigned region. Provide high-quality, balanced, and timely scientific information on disease states and company products/pipeline. Facilitate scientific exchange and maintain relationships with external experts in relevant therapeutic areas. Deliver clinical and scientific presentations in accordance with regulatory and compliance guidelines. Capture and communicate field insights to internal stakeholders to inform strategy and development. Respond to unsolicited medical information requests in the field. Support pharmacovigilance activities per company SOPs. Collaborate with leadership to develop and execute a regional medical plan. Lead or contribute to special projects such as training, advisory boards, and internal education initiatives. Training & Internal Education Maintain deep scientific and clinical expertise in oncology and other relevant therapeutic areas. Stay current on competitive landscape, clinical practice trends, and study methodologies. Support internal teams (e.g., commercial, clinical development) with scientific training and education as needed. Research & Clinical Trial Support Support investigator-initiated research and HCP-led data generation projects. Assist in the review and follow-up of submitted IITs. Collaborate with clinical operations on company-sponsored trials, including site selection and initiation activities. Communicate site-level insights to internal teams to support trial execution and strategy. Professional Organization & Advocacy Engagement Partner with internal colleagues to build relationships with professional societies, advocacy groups, and large clinical networks. Support medical affairs initiatives such as publications, advisory boards, and medical education programs. Health Economics & Outcomes Research (HEOR) Collaborate with Market Access and Medical Affairs to engage decision-makers and support evidence generation. Identify treatment pathways and opportunities for real-world data collection. Present scientific and value-based information to healthcare decision-makers (e.g., MCOs, PBMs, IDNs) when appropriate. Qualifications Education & Experience Advanced degree in a medical or scientific field (MD, DO, PharmD, PhD, NP, PA preferred). Minimum 8 years of relevant experience in oncology, immunology, or related therapeutic areas. At least 5 years in a field-facing medical role (e.g., MSL, FMD) within pharma or biotech. Experience in solid tumors preferred; GU and lung cancer experience strongly preferred. Clinical trial experience required. Valid driver's license required. Territory: MT, ID, UT, WY, CO, ND, SD, NE, KS, MO, and IA Skills & Competencies Strong knowledge of clinical research, treatment guidelines, and regulatory frameworks. Excellent communication, presentation, and interpersonal skills. Ability to build and maintain relationships with external stakeholders. Proven ability to work cross-functionally and independently. Strategic thinking and problem-solving skills. Proficiency in Microsoft Office and CRM/insights tracking systems. Commitment to compliance and teamwork within Medical Affairs. Compensation Entry-Level: $207,000 Highly Experienced: $240,000

Base Salary: $145K-$215K USD + Bonus | Full-Time | Remote A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting-edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune-mediated conditions. Be part of a team where innovation meets purpose-and help shape the next generation of therapies. Key Responsibilities Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications. Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards. Own budgets, timelines, and risk mitigation plans for all clinical programs. Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality teams. Drive inspection readiness and ensure audit preparedness. Qualifications Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role. Proven track record managing global trials and CROs. Strong knowledge of GCP, ICH, and regulatory requirements. Immunology or inflammatory disorder experience preferred. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

Hematologist Oncologist Opportunity MD CLINICS/MARY BIRD PERKINS ALEXANDRIA, LA Job Details: Occupation: Physician Specialty: Hematology/Oncology Employment: Full-Time Opportunity: Private Practice, Outpatient/Inpatient Board Certifications: BE/BC Degree: MD/DO Ideal Candidate: Experienced Physicians and Fellows are encouraged to apply. J1/H1B Visa candidates encouraged to apply. Will treat both Hematology and Medical Oncology patients. About the Role: MD Clinics, in partnership with Mary Bird Perkins, is proud to serve our community with a shared commitment to high-quality healthcare. As members of the community, we strive to bring care that's both affordable and approachable, because we believe deeply in the health and well-being of our neighborhood. We offer a unique Hematology/Oncology role in Alexandria that blends outpatient and inpatient care, working alongside a team of compassionate physicians. You'll serve a deeply appreciative patient population, including rural communities reached by three mobile Cancer Buses, making this a profoundly rewarding clinical experience. Our center delivers comprehensive, integrated cancer care with on-site infusion services, advanced imaging capabilities including PET, CT, and MRI, a specialty pharmacy, and an in-house lab. Alexandria offers a relaxed, family-friendly lifestyle with a low cost of living and a strong sense of community. Nestled along the Red River, it blends Southern charm with cultural richness, home to art museums, historic sites, and vibrant festivals. Outdoor enthusiasts enjoy nearby Kisatchie National Forest, while food lovers savor authentic Cajun and Creole cuisine. With easy access to regional airports and a central location in the state, Alexandria provides both convenience and comfort for professionals looking to make a meaningful impact while enjoying a balanced life. Recruitment Package: Top-Tier Compensation: $450K-$550K Base Salary, No cap on earning potential. Exact compensation may vary based on skills, experience, and location. Professional Growth: Enjoy CME reimbursement to further your education and skills. Comprehensive Benefits: Full employee benefits include: Medical, Dental, Vision, Short-Term and Long-Term Disability, Life, and Accidental Death. Secure Future: Robust retirement savings plan. Peace of Mind: We cover your malpractice insurance. Work-Life Balance: Paid time off, to ensure you maintain a healthy work-life balance. Community Care: Make a real difference by caring for patients in their local communities. Career Advancement: Seize leadership opportunities for career growth within our organization. Innovative Research: Enroll patients in cutting-edge clinical trials. Academic Excellence: Present and participate in research at prestigious conferences. Supportive Environment: Join a physician-led and managed organization that values clinical autonomy, work-life balance, and quality patient care while prioritizing your professional development and well-being. About the Practice and their Mission: MD Clinics is rooted in the principle of compassionate medical care. We are a patient-first experience dedicated to our communities with a focused desire to provide comprehensive and world-class services navigating complex care with the organizational strength and technical excellence of our healthcare team. MD Clinics is constantly striving for a transformational change in the way medical care is delivered, received, and perceived, to better the lives of our patients and communities we serve. In partnership with Louisiana's leading cancer care organization, Mary Bird Perkins Cancer Center, for over 50 years, has delivered on our mission of compassion and excellence to improve survivorship and lessen the burden of cancer through expert treatment, compassionate care, early detection, research, and education. The practice offers Hematology/Medical Oncology, Radiation Oncology, Palliative Care, and Clinical Trials & Research programs. Mary Bird Perkins Cancer Center is a proud partner of OneOncology. OneOncology is a national partnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Through OneOncology, partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. OneOncology's non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. If you would like to apply or learn more about this opportunity, please email your CV to ****************************** I look forward to speaking with you!

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified. **Candidate may reside in one of these areas: Denver, CO; St. Louis, MO; Minneapolis, MN.** **Territory covers: WY, CO, NM, ND, SD, NE, KS, MN, IA, MO, IL, IN** **Responsibilities** + Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience. + Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information. + Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups. + Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs). + Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc. + Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes + Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development + As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives. + Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes. + Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends. + Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications. + Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested. + Performing and completing administrative responsibilities, including reporting requirements in a timely fashion **Qualifications** + Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred + Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed] + Active clinical care, clinical research, or academia experience preferred + Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care. + Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution + Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred. + Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter. + Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-REMOTE _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US_ **Title** _Regional Medical Affairs Director - Great Plains_ **ID** _2025-2266_ **Category** _Medical Affairs_ **Type** _Full-Time_

The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified. **Candidate to reside in Houston, TX** **Territory covers: TX, LA, MS** **Responsibilities** + Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience. + Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information. + Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups. + Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs). + Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc. + Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes + Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development + As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives. + Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes. + Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends. + Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications. + Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested. + Performing and completing administrative responsibilities, including reporting requirements in a timely fashion **Qualifications** + Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred + Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed] + Active clinical care, clinical research, or academia experience preferred + Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care. + Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution + Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred. + Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter. + Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-REMOTE _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US_ **Title** _Regional Medical Affairs Director - Gulf Coast_ **ID** _2025-2267_ **Category** _Medical Affairs_ **Type** _Full-Time_

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Regional Medical Affairs Director (RMAD) is a member of a field-based team which is an extension of the US Regional Medical Affairs organization and is responsible for developing and enhancing professional relationships with specified key thought-leaders (KTLs), institutions, and organizations in their assigned geographical region. A RMAD focuses on medical & scientific engagement with identified healthcare and decision maker stakeholders by providing medical and scientific support via scientific exchange, addressing customers medical and scientific informational needs, and collaborating in mutually identified areas of medical, education, clinical research, and real-world experience/evidence. RMADs are recognized as an internal subject matter expert and provide appropriate medical and scientific support for internal teams as identified. **Candidate to reside in one of these areas: Dallas, TX; Phoenix, AZ** **Territory covers: TX, OK, NM, KS, AZ** **Responsibilities** + Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience. + Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information. + Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups. + Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs). + Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc. + Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes + Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development + As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives. + Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes. + Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends. + Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications. + Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested. + Performing and completing administrative responsibilities, including reporting requirements in a timely fashion **Qualifications** + Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred + Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed] + Active clinical care, clinical research, or academia experience preferred + Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care. + Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution + Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred. + Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter. + Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-REMOTE _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US_ **Title** _Regional Medical Affairs Director - Southwest_ **ID** _2025-2268_ **Category** _Medical Affairs_ **Type** _Full-Time_

Eagle Rock Pet Care is an established clinic that understands the deep bond between pets and their owners. We are located in Eagle Rock, CA and excited to be hiring a Medical Director to join our team! At Eagle Rock Pet Care, we're all about creating a place where you feel supported, valued, and excited to come to work every day. We see a wide variety of cases-including exotics-so there's always something new to learn and opportunities to grow. Here, you'll find a team that genuinely cares about helping each other thrive and making a difference for our patients. If you're looking for a welcoming, ambitious practice where learning is part of the daily routine, we'd love to meet you. Why choose us? * Practice Type: General Practice/Small Animal clinic with some exotics * Excellent Benefits: OFFERING SIGN-ON BONUS, RELOCATION ASSISTANCE, STUDENT LOAN ASSISTANCE, FUTURE OWNERSHIP OPTIONS, ETC.! * Medical Autonomy: Shape the future of this clinic, your way! Services Include: Routine Care, Surgery, In-House Diagnostics, Ultrasound, EKG, Exotics Care, and more. Learn More About Our Hospital! Check out our website here! Eagle Rock, CA is a historic neighborhood located in the Northeast Los Angeles area. It is the perfect blend of laid-back neighborhood charm and access to everything Los Angeles offers. Enjoy lazy afternoons hiking Griffith Park or catching a show at the Hollywood Bowl. Shop and dine at The Grove, explore art in Pasadena, or unwind on Santa Monica's beaches-all just a short drive away. Explore all Eagle Rock has to offer! Job Description * Part Time or Full Time Veterinarian * Proficient in general medicine and surgery Salary Range can vary from $150,000 to $200,000. Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate. We offer our veterinarians: * Flexible Scheduling & Medical Autonomy * Comprehensive Benefits (paid vacation/sick time/holidays, health, dental, vision, liability, 401K, life & supplemental insurance, employee assistance program & personal pet care discounts) * Future Ownership Opportunities * Competitive Compensation * DVM Mentor Network * Paid CE Allowance & Professional Dues Qualifications * Doctor of Veterinary degree, or equivalent, from an accredited university * Active veterinary state license * Current DEA License * USDA Accreditation * Strong leadership skills Additional Information WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Gist of the Role Looking for a change of scenery? We're looking for a Medical Director DVM to join our rustic practice found just a commutable stone's throw away from Chicago. Our charming red barn setting offers a peaceful escape from the bustling city yet is still conveniently close by. With flexible scheduling, you can enjoy a healthy work/life balance (AKA: work, then catch a show in Chicago!) Our compassion-driven culture promotes medical autonomy, allowing you to practice veterinary medicine on your own terms. Plus, our Partner Track program offers ownership opportunities and flexibility to invest in your medical interests. Join our team and experience the satisfaction of making a meaningful impact on the lives of pets and their owners while building a successful and fulfilling career. Job Description More About Our Practice Plum Creek Animal Medical Center is a well-established, progressive, fast-paced 3 doctor small animal practice with a nearby outpatient clinic. We are proud to be a 25-year AAHA-Certified hospital. Plum Creek offers many services to supply the best comprehensive care to our patients including Wellness and Preventive Care, Illness, Problem and Urgent Care, Surgery, Dentistry, Therapeutic Laser Therapy, In-House Diagnostics, Digital full body and dental radiology, Ultrasonography, Acupuncture, Medical and/or Vacation Boarding and more. Our charming red barn setting supplies the perfect escape from the hustle and bustle of Chicago while still being close to the city. We highly value work-life balance and offer flexibility on scheduling, so you can enjoy your personal life without sacrificing your career. Our limited-service outpatient clinic provides doctors and staff with the ability to enjoy variety while the records and clients are shared between locations. You're here for pets, we're here for you. * Flexible scheduling for work-life balance * Medical autonomy to practice medicine your way * Future ownership opportunities * Just a short distance from Chicago * Extremely generous signing bonuses * Full benefits - PTO, health/dental/vision/life insurance, 401K, pet care discounts, etc. * Competitive compensation * DVM mentor network * Paid CE allowance & professional dues * Also offering relocation assistance and student loan aid * Commuter stipend for gas/tolls if needed We're Looking For * Full time veterinarian- Medical Director * Compassionate, team player and strong communicator * Proficient in general medicine and surgery * Experience preferred but new graduates seeking mentorship are encouraged to apply! #IND5 Qualifications * Doctor of Veterinary degree, or equivalent, from an accredited university * Current DEA License or obtained upon hire * Active Veterinary State License * USDA Accreditation or obtained upon hire Salary Range can vary from $100,000 to $150,000. Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate. Additional Information Hiring eligibility may be contingent to a candidate authorizing and completing a satisfactory background check. WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex's world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables. Key Duties and Responsibilities: * Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives. * Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices. * Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed. * Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents. * Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed. * Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs. * Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable. * Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries. * Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices. * Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources. * Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter. * Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports. * Reviews and provides oversight of safety sections of clinical study reports. * Provides a contributory role in Partner /Affiliate agreements and interactions, as needed. * Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development. * Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective. * Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities. * Facilitates the growth and development of staff and direct reports. Knowledge and Skills: * Extensive knowledge of GCP, ICH and Global regulations. * In-depth and comprehensive knowledge of General Medicine. * Strong leadership skills with the ability to communicate effectively in a matrix environment. * Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging. * Extensive knowledge of Benefit-Risk strategies and decision-making. * Ability to multi-task, adeptly handling multiple demands. Education and Experience: * MD, DO or equivalent ex-US medical degree * 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 Pay Range: $312,000 - $468,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options. The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence. The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines. The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation. Responsibilities: Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals. Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization. Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents. Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials. Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices. Represent Medical Writing and provide medical writing expertise on cross-functional teams. Develop detailed timelines for document development in line with company goals and SOPs. Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers. Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables). Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable. Coordinate with the Regulatory Operations team to publish documents that meet eSubmission‑ready standards. Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates. Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations. Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable. Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC). Qualifications: BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred Success in managing resources (internal, external, or hybrid) Prior direct experience leading medical writing teams responsible for global marketing authorization applications Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology Excellent technical writing and editorial skills; excellent attention to detail Strong ability to understand and interpret medical and scientific data Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote Excellent communication, interpersonal, and organizational skills Experience working on cross-functional teams Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule. #LI-Hybrid

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG. Job Description Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety Provides oversight of medical safety evaluation for assigned global investigational products Coordinates and contributes to medical assessment for assigned global post-marketing products Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation. Partner with relevant internal and/or external experts to fulfill responsibilities Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities. Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate) Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs Oversees development and preparation of Risk Management Actions Plans for regulatory filings Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications Education: Medical Degree (MD or DO), and current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience Professional Experience: Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Ability to travel domestically & internationally as required, typically up to 30% Knowledge and Skills: Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines) Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Demonstrated authorship of PSUR, REMS or RMP, and DSUR Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion Experience with ARISg or other safety database programs Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG. Job Description Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety Provides oversight of medical safety evaluation for assigned global investigational products Coordinates and contributes to medical assessment for assigned global post-marketing products Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation. Partner with relevant internal and/or external experts to fulfill responsibilities Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities. Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate) Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs Oversees development and preparation of Risk Management Actions Plans for regulatory filings Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications Education: Medical Degree (MD or DO), and current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience Professional Experience: Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Ability to travel domestically & internationally as required, typically up to 30% Knowledge and Skills: Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines) Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Demonstrated authorship of PSUR, REMS or RMP, and DSUR Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion Experience with ARISg or other safety database programs Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: