Medical Director jobs at Alliance Health

Med First is committed to expanding access to high-quality primary care in underserved communities. We're looking for a Medical Director who can lead with both clinical excellence and operational insight- advancing value-based care and sustainable growth across 25+ clinics. How You'll Make an Impact: Lead clinical strategy, quality, and patient safety across diverse, community-based settings Advance value-based care, care management, and use of innovative AI models Partner with operations/finance on access, growth, and performance (MLR, quality, experience) Develop clinical leaders, recruit/retain talent, and foster a culture of compassion + accountability Provide direct patient care in one of our primary care sites Who you are: Board-certified (FM/IM) with 5+ years of clinical leadership, success in value-based and multi-site environments, and a mission-driven, collaborative mindset. Location: Hybrid: 2 days work in clinic at our Roxboro NC clinic and 2 days administrative working remotely.

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!

WHO WE ARE… Newport Mental Health (NMH) is a progressive high-energy organization that uses state of the art person-centered recovery approach to help individuals recover from mental illness and substance use disorders. NMH extends its trauma informed evidence-based services to children, adolescents, families, and adults. Our services vary from outreach, specialized program, mental health, school-based therapy, substance use therapy, community-based therapy, and outpatient clinic. For more information visit our website: *************************** WHO WE ARE LOOKING FOR… Mission- Aligned: You are excited to be a part of Newport Mental Health's mission to improve the lives of our clients living and working in Newport County by providing the highest quality of care. Ally: You intentionally foster belonging, personal growth, and empowerment for all. You are a strong advocate for the BIPOC, LQBTQIA+, Woman, Veteran, and other underrepresented communities. Solution Orientated: You are driven to think of different approaches to narrow the gap which leads to positive and effective changes. Time Management: You are a conscious planner and a thoughtful decision maker who adheres to deadlines. WHAT WE OFFER… Excellent Health and Dental Insurance. Vacation, Sick and Personal time accrued biweekly. Up to 11 Paid Holidays. Retirement program through Mutual of America. Additional supplemental insurance programs. Tuition reimbursement. Mileage reimbursement. Employer paid life insurance. Flexible spending account (FSA) and dependent care (DCA) spending accounts. WHAT YOU WILL BE DOING (ESSENTIAL DUTIES) … Responsible for the provision and oversight of psychiatric medical services with a diverse patient population. Provides psychiatric assessment and treatment to clients while serving as a consultant to other staff. Participates in quality improvement, quality assurance, peer review and medical staff activities. Participates as a member of the Management Team in the organization's decision-making structures and processes. Main Duties and Responsibilities: Translate mission, vision, values, and strategic planning into action plans. Build a shared vision with Agency staff and acts as a positive catalyst of organizational change and growth. Participate as a member of the Management Team in the organization's decision-making structures and processes. Co-Chair regular Medical/Clinical Staff Meetings with the Clinical Director. Responsible for the clinical and administrative supervision and support of all NMH prescribers. Holds staff accountable for meeting standards of care and job expectations including reasonable productivity and no-show standards. Oversee clinical policy development and adherence. Set the standards for medical and clinical care. Chair of the Pharmacy and Therapeutics committee. Provide clinical guidance, role-models, coaches, and assists in the areas of professional and clinical development, team building, and patient care. Collaborate with the Chief Executive Officer and Chief Clinical Officer to oversee the quality and effectiveness for the delivery of clinical care in all NMH departments. Assist in the planning, development, implementation, and oversight of programs, including integrated care. Develop innovative ways, both within the organization and externally, to improve the quality and performance of services. Support medical staff in the design and fidelity to the Just in Time centralized scheduling process. Provide leadership to guide the organization's efforts in continuous quality improvement. Communicate effectively with staff, clients, natural supports, and community partners. Maintain thorough, timely clinical documentation meeting Federal and State guidelines and standards including medical staff evaluation and monitoring coding. Ensure the cost effective and efficient delivery of care, and the appropriate utilization of resources based on the MTM productivity modeling tool. Promote integrated care and care management activities of our Integrated Health Homes and participation in our Integrated Health Partnership Medicaid accountable care initiatives. Provide consultation to the Chief Executive Officer, Chief Clinical Officer, Chief Operating Officer, Division Directors, Supervisors, and staff regarding medical and psychiatric issues. Meet leadership standards for the CCBHC Medical Director role and Joint Commission standards. Maintain familiarity with State and Federal regulations for prescription medications (including controlled substances) and prepare organization policies and procedures to guide the use of prescription medications and controlled substances at NMH. Participate actively in professional organizations in order to further education, professional growth, and networking. Obtain and record information about client's medical and psychiatric histories for the purpose of diagnostic formulation and treatment planning. Conduct comprehensive Psychiatric Assessments. Conduct and record mental status exams to monitor response to treatment. Order consultations to assist in difficult diagnostic formulation. Order and interpret laboratory studies, EKG's, EEGs, and neuroimaging to provide accurate diagnostic information as well as to monitor side effects and other co-occurring medical conditions. Prescribe and monitor psychotropic medications according to best practice standards and in concert with the Center's policy and procedures and Pharmacy and Therapeutics guidelines. Discuss risks and benefits and obtain informed consent from client (or personal representative) before initiating pharmacotherapy. Demonstrate the ability to integrate general medical concerns into psychiatric practice as evidenced by attention to drug interactions, complications of medical illness and behavioral effects of somatic illness. Provide psycho education to clients and families. Conduct and supervise treatment of clients with substance use disorders. Perform emergency assessments and admit to the mental health unit of Newport Hospital, as necessary. Participate in the Center and Hospital physician on-call coverage schedule. Provide consultation and follow-up communication with law enforcement agencies, community agencies, medical facilities, and inpatient units. Participate actively in team communication processes that ensure appropriate management of cases 7 days per week. Seek and actively participates in regularly scheduled supervision with emphasis on an openness to receive feedback and integrate recommendations in the execution of job responsibilities. Requirements WHAT WE EXPECT OF YOU… Valid, unlimited Rhode Island medical license as an M.D. or D.O. Completion of a residency program in psychiatry. Board-eligible or board certified in psychiatry. Full, unrestricted Licensure to practice psychiatric medicine in the State of Rhode Island. Full, unrestricted DEA license to prescribe medication. Minimum five (5) years of clinical practice. Minimum (2) years administrative experience in a psychiatric/behavioral health setting. APPLY NOW Submitting your application is a great way to learn more about Newport Mental Health. If you have questions about how your experience aligns with our job openings or know someone who would be a great candidate for our job openings, please contact Human Resources: Human Resources Newport Mental Health 42 Valley Road Middletown, RI 02842 Tel: ************ Fax: ************ Newport Mental Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Job DescriptionDescription: WHO WE ARE… Newport Mental Health (NMH) is a progressive high-energy organization that uses state of the art person-centered recovery approach to help individuals recover from mental illness and substance use disorders. NMH extends its trauma informed evidence-based services to children, adolescents, families, and adults. Our services vary from outreach, specialized program, mental health, school-based therapy, substance use therapy, community-based therapy, and outpatient clinic. For more information visit our website: *************************** WHO WE ARE LOOKING FOR… Mission- Aligned: You are excited to be a part of Newport Mental Health's mission to improve the lives of our clients living and working in Newport County by providing the highest quality of care. Ally: You intentionally foster belonging, personal growth, and empowerment for all. You are a strong advocate for the BIPOC, LQBTQIA+, Woman, Veteran, and other underrepresented communities. Solution Orientated: You are driven to think of different approaches to narrow the gap which leads to positive and effective changes. Time Management: You are a conscious planner and a thoughtful decision maker who adheres to deadlines. WHAT WE OFFER… Excellent Health and Dental Insurance. Vacation, Sick and Personal time accrued biweekly. Up to 11 Paid Holidays. Retirement program through Mutual of America. Additional supplemental insurance programs. Tuition reimbursement. Mileage reimbursement. Employer paid life insurance. Flexible spending account (FSA) and dependent care (DCA) spending accounts. WHAT YOU WILL BE DOING (ESSENTIAL DUTIES) … Responsible for the provision and oversight of psychiatric medical services with a diverse patient population. Provides psychiatric assessment and treatment to clients while serving as a consultant to other staff. Participates in quality improvement, quality assurance, peer review and medical staff activities. Participates as a member of the Management Team in the organization's decision-making structures and processes. Main Duties and Responsibilities: Translate mission, vision, values, and strategic planning into action plans. Build a shared vision with Agency staff and acts as a positive catalyst of organizational change and growth. Participate as a member of the Management Team in the organization's decision-making structures and processes. Co-Chair regular Medical/Clinical Staff Meetings with the Clinical Director. Responsible for the clinical and administrative supervision and support of all NMH prescribers. Holds staff accountable for meeting standards of care and job expectations including reasonable productivity and no-show standards. Oversee clinical policy development and adherence. Set the standards for medical and clinical care. Chair of the Pharmacy and Therapeutics committee. Provide clinical guidance, role-models, coaches, and assists in the areas of professional and clinical development, team building, and patient care. Collaborate with the Chief Executive Officer and Chief Clinical Officer to oversee the quality and effectiveness for the delivery of clinical care in all NMH departments. Assist in the planning, development, implementation, and oversight of programs, including integrated care. Develop innovative ways, both within the organization and externally, to improve the quality and performance of services. Support medical staff in the design and fidelity to the Just in Time centralized scheduling process. Provide leadership to guide the organization's efforts in continuous quality improvement. Communicate effectively with staff, clients, natural supports, and community partners. Maintain thorough, timely clinical documentation meeting Federal and State guidelines and standards including medical staff evaluation and monitoring coding. Ensure the cost effective and efficient delivery of care, and the appropriate utilization of resources based on the MTM productivity modeling tool. Promote integrated care and care management activities of our Integrated Health Homes and participation in our Integrated Health Partnership Medicaid accountable care initiatives. Provide consultation to the Chief Executive Officer, Chief Clinical Officer, Chief Operating Officer, Division Directors, Supervisors, and staff regarding medical and psychiatric issues. Meet leadership standards for the CCBHC Medical Director role and Joint Commission standards. Maintain familiarity with State and Federal regulations for prescription medications (including controlled substances) and prepare organization policies and procedures to guide the use of prescription medications and controlled substances at NMH. Participate actively in professional organizations in order to further education, professional growth, and networking. Obtain and record information about client's medical and psychiatric histories for the purpose of diagnostic formulation and treatment planning. Conduct comprehensive Psychiatric Assessments. Conduct and record mental status exams to monitor response to treatment. Order consultations to assist in difficult diagnostic formulation. Order and interpret laboratory studies, EKG's, EEGs, and neuroimaging to provide accurate diagnostic information as well as to monitor side effects and other co-occurring medical conditions. Prescribe and monitor psychotropic medications according to best practice standards and in concert with the Center's policy and procedures and Pharmacy and Therapeutics guidelines. Discuss risks and benefits and obtain informed consent from client (or personal representative) before initiating pharmacotherapy. Demonstrate the ability to integrate general medical concerns into psychiatric practice as evidenced by attention to drug interactions, complications of medical illness and behavioral effects of somatic illness. Provide psycho education to clients and families. Conduct and supervise treatment of clients with substance use disorders. Perform emergency assessments and admit to the mental health unit of Newport Hospital, as necessary. Participate in the Center and Hospital physician on-call coverage schedule. Provide consultation and follow-up communication with law enforcement agencies, community agencies, medical facilities, and inpatient units. Participate actively in team communication processes that ensure appropriate management of cases 7 days per week. Seek and actively participates in regularly scheduled supervision with emphasis on an openness to receive feedback and integrate recommendations in the execution of job responsibilities. Requirements: WHAT WE EXPECT OF YOU… Valid, unlimited Rhode Island medical license as an M.D. or D.O. Completion of a residency program in psychiatry. Board-eligible or board certified in psychiatry. Full, unrestricted Licensure to practice psychiatric medicine in the State of Rhode Island. Full, unrestricted DEA license to prescribe medication. Minimum five (5) years of clinical practice. Minimum (2) years administrative experience in a psychiatric/behavioral health setting. APPLY NOW Submitting your application is a great way to learn more about Newport Mental Health. If you have questions about how your experience aligns with our job openings or know someone who would be a great candidate for our job openings, please contact Human Resources: Human Resources Newport Mental Health 42 Valley Road Middletown, RI 02842 Tel: ************ Fax: ************ Newport Mental Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Hematology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies for the first FDA approved CRISPR-cas9 medicine (Exa-Cel) for the treatment of Sickle Cell Disease and Infusion dependent B-Thalassemia, including the development of the life cycle management plan. The successful candidate will be an experienced people manager who is passionate about developing talent to whom the HEME Global Medical team will report to. The individual will partner with the International and North America regions to drive globally aligned medical brand and evidence generation plans which reflect country and regional insights and needs. This individual must work effectively with his/her cross-functional counterparts in Development, Research, and Commercial, and will sit on the HEME Disease Strategy Team to define and implement the medical affairs strategy for Exa-Cel. Key Duties and Responsibilities: * The Executive Director, HEME Global Strategy, will have global responsibility to build the Global Medical strategy for Exa-Cel. * Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance. * Execute the Global components of the medical strategy plan. * Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partner functions to identify evidence gaps and coordinate evidence generation to generate data in support of global product initiatives. * Ensure all Medical Affairs initiatives are aligned with overall brand plans and in compliance with corporate policies and regulatory requirements. * Determine staffing requirements for the group and successfully recruit, develop and retain an effective team. The successful candidate will evaluate and update process and operating procedures for this group that are consistent with general guidance already in place for the organization. Knowledge and Skills: * Proven relationship building competencies with external stakeholders * Excellent understanding of healthcare systems in assigned region and the needs of payors * Overall strong ability to understand the disease state, mechanism of action, value proposition - both from an absolute and relative/competitive standpoint. * Strong speaking and presentations skills to ensure trustful and authoritative interactions with all stakeholders sets (KOLs, payers, patients, patient advocacy groups, etc.). * Clear understanding of the Pharma industry environment and ability to build and create a strong strategic plan in collaboration with the Global Medical team and other stakeholders. * Ability to work comfortably within a cross-functional and matrix environment. * Therapeutic experience is preferred * Experience of working in a regional medical affairs role is highly desirable * Travel up to 30% required. Education and Experience: * The successful candidate will have a medical degree or PhD from a well-regarded institution and at least 7 years of experience in industry, with at least 3 of those in an industry managerial role leading clinical and/or medical programs. The ideal candidate will have sub-specialty training in Hematology / Transplant medicine. * In addition to deep technical competence, she/he will exhibit sound business judgment with an understanding of the significant financial investments and the ultimate impact that the role has on product opportunities and on the Company. * The Executive Director, HEME Global Strategy will be a natural leader, possessing the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment. * The successful candidate will possess excellent communication and relationship skills. S/he will communicate with a style that is clear, complete and concise. S/he will have well-established networks and be able to develop and maintain strong professional relationships internally and externally by gaining credibility and confidence with others. Pay Range: $311,200 - $466,800 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. #LI-Hybrid 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

The Executive Medical Director, Early Development will be a strategically minded, hands-on early clinical development expert with the responsibility for overseeing the transition of projects from research into clinical development, and for developing strategy for early clinical development of novel therapies including application of biomarkers in Phase 1b/2a studies. Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork focus of the candidate. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. The individual will collaborate with talented and dedicated colleagues across R&D, Clinical & Quantitative Pharmacology, and other key stakeholder functions. This position will be a critical element in Vertex's approach to creating an effective bridge between discovery research and clinical development. Key Duties and Responsibilities: * Leading a group of physician-scientists involved in clinical research * Work closely with other functional experts across the organization * Provide medical leadership and translational medicine expertise on cross-functional Project Teams * Co-chair of Protocol Review Committee (ePPRC) and Dose Escalation Meetings (DEM) meetings for Phase 1 SAD/MAD studies * Develop early clinical development plans that are innovative, safe, efficient and create a foundation for decision making * Provide clinical and translational leadership to drive the design and interpretation of Phase 1-2a studies, in close collaboration with experts in Clinical Biomarkers, Clinical Pharmacology, Modeling & Simulation, and Clinical Operations * Work with teams to ensure effective execution of Phase 1-2a studies * Collaborate with Global Patient Safety to perform safety evaluations in early development programs * Support exploratory biomarker efforts in collaboration with Clinical Biomarkers and Research groups to aid in clinical and project decision making * Engage with external academic and industry partners in planning and executing strategy and clinical studies * Engage with external scientific and medical experts to bring insight to development programs * Work with colleagues across the research and clinical organizations to foster an end-to-end view of drug development, with a focus on improving patient care * Serve as a people manager and mentor within the organization to young new-to-industry physicians * Have financial accountabilities and human resource responsibilities for assigned staff Knowledge and Skills: * Global clinical research experience, and experience interacting with regulatory authorities is highly desired * Ability to work collaboratively in a fast-paced, matrix environment * Ability to work independently to resolve challenges * Enterprise-wide thinking and ability to work in ambiguity * Excellent oral and written communication skills * Board certification/eligibility in a specialty is highly desired Education and Experience: * MD, DO or equivalent ex-US medical degree required + PhD (highly desired) * 15+ years of translational medicine/translational research experience, including time managing clinical trials and clinical development programs * Strong record of basic and/or translational research productivity * Experience with design, execution, and analysis of Phase 1-2a, first-in-human and POM/POC clinical studies * Experience across multiple therapeutic areas and modalities * Effective at building alliances across functions * Excellent interpersonal communication skills, able to drive collaborations across a matrixed organization * People-management experience required #LI-KM4 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

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_

Vertex Pharmaceuticals is searching for an experienced Medical Director to lead strategic and tactical activities for a broad range of ongoing clinical development activities within the Hematology clinical development team. You will work as part of multidisciplinary cross-functional teams on clinical development strategy, clinical trial data analysis and publications, clinical development related data generation activities, ongoing clinical trial execution, and contribute to global regulatory submissions. You may also participate in pipeline development activities in the Hemoglobinopathies program, depending on background and interest. Key Duties and Responsibilities: * Serve as a clinical development lead for hematology clinical development strategy and overall clinical development plans * Serve as the clinical development lead to facilitate analysis of clinical trial data in context of strategic internal and external needs, including publication strategy and publication plan execution as well as associated external communications activities * Serve as the clinical development lead for additional data generation activities such as those related to read world evidence studies, post- approval studies, and health related outcomes studies * Contribute clinical and scientific subject matter expertise for global regulatory activities and documents including post- approval information requests and reports, labeling, and data submissions such as study reports and summary documents. * Provide subject matter expertise and input for in scope pipeline development activities, such as preclinical programs or external innovation/business development * Act as liaison between Clinical Development and other internal groups for hematology program related working groups * Represent Vertex/VCGT to outside medical personnel for clinical development related activities, including supporting medical monitors of ongoing clinical trials, advisory boards, and data presentations. Knowledge and Skills: * Ability to work collaboratively in a fast-paced, team-based, matrixed environment and to function independently, as appropriate * Utilize novel and creative methods to independently resolve clinical development problems * Working knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and execution * Experience in analysis of research data and publications * Excellent verbal and written communication skills * A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society Education and Experience: * MD, MD/PhD, DO or the international equivalent * Board certification/eligibility in internal or pediatric medicine or another relevant medical field is highly desired; clinical development/experience in hematology and/or oncology, including hematopoietic stem cell transplant medicine, is a plus * 10 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience including working on cross-functional teams. * Experience in analysis of research data and publications including a working knowledge of biostatistics. * Working knowledge of GCP including medical monitoring; experience with scientific/clinical research methods and with the design and execution of clinical trials. * Ability to travel (up to 15%) to support program activities as needed Pay Range: $237,200 - $355,700 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

The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development. Key Duties and Responsibilities: * Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance * Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution * Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate * Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies * Represents Vertex to outside medical personal in the development of clinical protocols and study conduct * Performs other duties as assigned related to clinical programs Knowledge and Skills: * Excellent oral and written communication skills * Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate * Effective at building alliances across functions, based on end-to-end drug development thinking and experience Education and Experience: * MD, DO or equivalent ex-US medical degree * Board certification/eligibility in a specialty field is highly desired * Typically requires 10 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience * Typically requires experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design * Typically requires experience with design, execution, and analysis of clinical trials required #LI-AR1 Pay Range: $237,200 - $355,700 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. #LI-Hybrid 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

The Global Medical Affairs Strategy Medical Director will provide medical leadership for the Povetacicept programs. Povetacicept (pove) is an enhanced, dual BAFF/APRIL inhibitor in pivotal development for the treatment of IgA Nephropathy (IgAN), primary Membranous Nephropathy (pMN), and generalized Myasthenia Gravis (gMG) that has best-in-class and pipeline-in-a-product potential across a variety of autoimmune diseases. This role will be responsible for developing the medical strategy and medical plan under the direction of the Global Medical Affairs Lead/Executive Director, as well as executing against the medical plan encompassing the pove programs, with a focus on gMG. This role will collaborate closely with cross-functional groups to ensure that scientific and medical strategies are aligned with broader corporate and key stakeholder needs, as well as ensuring the voice of the patient and medical community is integrated into product strategies. Key Duties and Responsibilities: * Main focus will be on gMG Medical Affairs activities, but may contribute to activities for the kidney indications for pove (i.e., IgAN and pMN), as needed. * Develops medical affairs plans, including Launch and Life Cycle Management plans * Critically interprets scientific data, determines the potential impact of new research on clinical practice, and uses scientific and clinical data to formulate frameworks and disease management approaches * Provides input from medical community into clinical development and commercial strategies * Effectively communicates scientific data through presentations and publications * Ensures country/regional insights and needs are considered in global medical strategies and activities * Provides scientific input and expertise as a medical reviewer and supports the development of global medical, commercial, regulatory, and reimbursement documents * Performs/oversees medical/scientific training for Medical, Commercial, and other internal stakeholders * Reviews investigator-sponsored study (ISS) proposals and other research grants Knowledge and Skills: * Deep understanding of global medical, regulatory and commercial (including payer) environments * Excellent understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with key external stakeholders (e.g., healthcare providers, payers, advocacy bodies) * Deep understanding of market access in key countries * Excellent written and oral communication skills to influence others internally/externally * Ability to develop relationships in a highly matrixed environment, as well as external relationships with global, regional and local thought leaders and industry experts * Ability to engage in positive dialogue and resolve conflicts in a constructive manner Education and Experience: * M.D. degree or equivalent (e.g., MBBS, D.O.) * Strong immunology and/or neurology background preferred, as role will focus on gMG * Requires at least 3 years of experience working in the biotech/pharma industry or the equivalent combination of education and experience. Experience working on asset(s) in highly competitive disease area(s) is a plus. * Requires experience in a Medical Affairs function and in the analysis of research (pre-clinical or clinical) data and publications; working knowledge of biostatistics as well as scientific and clinical research methods, and clinical study design. Pay Range: $236,800 - $355,200 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. #LI-Hybrid 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

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 Dallas, TX or 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_

The Executive Medical Director, Global Medical Lead (GML), Pain is a critical leadership role in Global Medical, responsible for the global medical strategy and implementation and tracking of global activities for a designated disease area(s). Key responsibilities include, but are not limited to, disease area specific Integrated Medical Plan development, including the publication plan, global launch strategy and execution, scientific leadership, external medical expert engagement, and strategic alignment with commercial and other cross-functional business partners. This leader will also be critical in leading post-approval evidence generation strategy in the disease area. This leader reports directly to the VP, Global Medical and is a core member of the Global Medical leadership team. They will lead the global medical affairs team for the designated disease area(s) and represents Medical Affairs in all Global strategic teams with Development and Commercial, including the Disease Strategy Team (DST) to drive cross-functional alignment, anticipate future needs, and contribute to Medical Affairs and Vertex's long-term success. Key Duties and Responsibilities: Medical Strategy * Lead the development, implementation, execution, and communication of the Integrated Medical Plans, including but not limited to medical strategy, global tactical plan, publication, congress and post-approval evidence generation plan, in collaboration with Clinical Development, HEOR, RWE, Medical Writing, and other internal stakeholders across Vertex * Ensure alignment of medical strategy with organizational objectives by integrating individual and disease area team goals with Vertex and DST priorities, and the goals of cross-functional partners * Expertly distills insights and actionable outcomes that inform strategy and drive the greatest impact for Medical Affairs * Establishes and tracks medical KPIs that demonstrate impact on business and patient outcomes. * Applies structured problem-solving and root cause analysis to identify solutions and make decisions that maximize medical and business impact * Able to identify what is important and impactful to medical and the wider business, prioritize competing demands and communication to key stakeholders * Accountable for development of the global DA budget, management of funds allocation, and associated tracking to ensure alignment with Medical Affairs priorities and efficient resource allocation Scientific Excellence * Serve as product and disease area expert and primary contact point for all global disease area related issues with the external community and internally at Vertex * Able to lead development of peer reviewed publications, congress presentations and evidence generation to shape clinical practice * Closely follow medical developments within disease area and disseminate new information to transform clinical trends and emerging data into new plans * Lead the development of global scientific communications and materials including materials for global led symposia, advisory boards, and training. * Accountable for medical review of assigned brand related content and global medical content aligned with Vertex SOPs External Partnerships * Represent Vertex at scientific and medical forums, including medical education forums, scientific societies, patient advocacy groups, and congresses. * Accountable for engaging and cultivating relationships with leading global key thought leaders (TL) to gain greater understanding of the disease area, and insights into unmet patient needs Medical Communication * Tailors communication to stakeholder needs, building trust and understanding across diverse audiences. * Deliver external presentations (advisory board meetings, symposia, other medical education meetings) to enhance the medical knowledge of pipeline and marketed products, as required and in accordance with relevant regulations and procedures * Support disease area training across the company as required * Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for pipeline therapies and marketed medicines Regional Medical and Cross Functional Collaboration * Accountable for go to market model and medical partnership in commercialization with global cross-functional colleagues. In absence of regions teams, country go to market model remains the responsibility of the GML. * Support regional Medical Affairs and Medical Excellence teams from launch through lifecycle via timely delivery of fit-for-purpose training and core materials. * Responsible for driving alignment on medical content/messaging within the organization to ensure maximal functional and regional input. * Medical Affairs leader on key global cross-functional product and development strategic focused teams, including DST and relevant sub teams * Effectively represents and communicates DST priorities to the medical function and proactively communicates and represents medical needs to DST * Chair the Global Medical Area Team (GMAT) for the disease area and accountable for deliverables * Provide strategic Medical Affairs leadership on relevant commercial teams: Launch Team, and Global brand teams for product * Represent Medical Affairs in label discussions * Support Access, Patient Advocacy, Policy, and Corporate Communications teams with medical/scientific expertise and materials review. Evidence Generation and Access * Leads strategy, development and execution of Life Cycle Management in partnership with HEOR, including Integrated Evidence Generation plan in close collaboration with key internal stakeholders * May act as medical monitor for studies falling under the Medical Affairs scope in collaboration with Clinical Development, Real World Evidence, Health Economics and Outcomes Research, and Clinical Operations * Lead oversight and management of ISS programs, and in collaboration with Regional Medical leadership, conduct critical scientific and medical review of ISS protocols * As applicable, lead Managed Access Committee for assets with a Managed Access Program (MAP); may act as a Medical Monitor for MAP Team/People Management * Provide strong leadership to dedicated disease area medical team, inspiring and empowering a dedicated medical team, and promoting a culture of continuous development. * Accountable for the recruitment, development, management and coaching the global medical team * Leverages the capabilities and expertise of the team to ensure successful execution of medical plans * Identifies and addresses team skill gaps, considering how to accelerate internal talent or attract external to meet needs of a future-ready organization. * Adheres to formal goal-setting, talent and performance cycles ensuring individual development plans (IDPs) are in place * Navigates ambiguous or rapidly evolving situations, and coach the team during periods of uncertainty or change. Compliance and Pharmacovigilance: * Ensure compliance of medical activities according to global and regional guidelines and in accordance with Vertex Code of Conduct, rules and regulations, company policies, SOPs, GCP and ICH * Ensure self and other medical colleagues have the required skills to identify and report AEs appropriately * Contribute to managing external communication when significant safety issues arise, with the wellbeing of patients being the ultimate goal Education and Experience: * MD, PhD, PharmD or other advanced life sciences degree require * Typically requires 15 years of experience and 7 years of supervisory/management experience or the equivalent combination of education and experience * 6 or more years of relevant leadership experience in medical affairs and/or clinical development, including experience in both Global and Country/Region desired * 2 or more years of industry experience in disease area Pay Range: $316,800 - $475,100 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. #LI-Hybrid 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

Job Description Senior Director, Medical Writing The Senior Director, Medical Writing, will work with cross-functional teams to develop, write, and review clinical and regulatory documents, ensuring the documents are of high quality and comply with internal and external standards. This position reports to the SVP Regulatory Affairs & Quality, and is an onsite position based in San Diego. Key Responsibilities: Lead the Medical Writing function to plan, prepare, write, edit, format, and finalize non-clinical, clinical, and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, briefing books, annual reports/development safety update reports (DSURs), manuscripts and posters. Manage external writing vendors in the delivery of the Medical Writing book of work. Partner with regulatory affairs and cross-functional SMEs in developing and executing strategies for organizing and preparing documents for regulatory health authority submissions. Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams. Lead the development of templates, style guidelines, and SOPs for clinical documentation. Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements. Effectively collaborate with Research & Development colleagues, including, but not limited to, clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery. Contribute to the future growth and development of the BlossomHill's Medical Writing function, providing insights, experience and counsel to the SVP on strategic planning initiatives. Qualifications: Ph.D. in Life Science related discipline or related field. 10+ years of applicable regulatory affairs experience in a pharmaceutical or biotechnology industry role. Experience in oncology therapeutic areas required (solid tumor and/or hematology) Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format. Excellent organizational and project management skills. Ability to work effectively with other team members and departments at various levels, as well as with CROs and external consultants. Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.

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

The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities: * Independently authors routine and complex clinical and regulatory documents * Provides strategic input into program-level plans * Deep insight into how different functions contribute to the successes of the team * Aligns, coordinates, and builds consistent information and messages across clinical program(s) * Provides leadership related to the activities of Medical Writing Science and manages a team * Participates in developing and implementing goals and initiatives for Medical Writing Science * Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents * Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements Knowledge and Skills: * Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives * Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues * Proven track record of anticipating potential problems and preparing contingency plans as needed * Understanding of scientific disciplines beyond own specialty area * Experience managing direct reports and guiding staff development * Experience with marketing authorization application regulatory submissions Education and Experience: * Bachelor's degree in relevant discipline * Ph.D. (or equivalent degree) * Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $157,600 - $236,400 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: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. 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. #LI-Remote 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: