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Medical Director jobs at Johnson & Johnson

- 1153 jobs
  • Medical Director, Medical Affairs, Orthopedics (Sports / Joints)

    Johnson and Johnson 4.7company rating

    Medical director job at Johnson & Johnson

    At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Affairs - MD Job Category: Scientific/Technology All Job Posting Locations: Abilene, Texas, United States, Abilene, Texas, United States, Akron, Ohio, United States, Alpharetta, Georgia, United States, Anaheim, California, United States, Anchorage, Alaska, United States, Annapolis, Maryland, United States, Appleton, Wisconsin, United States, Asheville, North Carolina, United States, Ashland, Kentucky, United States, Aurora, Illinois, United States, Bangor, Maine, United States, Beckley, West Virginia, United States, Billings, Montana, United States, Birmingham, Alabama, United States, Bismarck, North Dakota, United States, Bridgeport, Connecticut, United States, Burlington, Vermont, United States, Carmel, Indiana, United States, Chandler, Arizona, United States, Charleston, South Carolina, United States, Chattanooga, Tennessee, United States, Colorado Springs, Colorado, United States of America, Concord, New Hampshire, United States, Cumberland, Rhode Island, United States of America {+ 23 more} Job Description: Johnson and Johnson is currently seeking a Medical Director, Medical Affairs, Orthopedics (Sports/ Joints). This is a Fully Remote in the United States This is a remote role available in the Continental US. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location across the country to apply. About Orthopedics Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that's reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering State of the Art technology to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech The Medical Director, Medical Affairs, Orthopedics role provides medical affairs support within an assigned platform / sub-platform (Sports / Joints) within the Orthopedics Business Unit of Johnson & Johnson MedTech. Leading with both outside-to-inside vision to assimilate opportunities of unmet patient and provider needs, and inside-to-outside vision to communicate the medical, surgical, and scientific content. This role provides medical input throughout product development , W orking closely with R&D Teams and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential patient safety issues. This position involves cross-functional collaboration with Clinical Affairs and HEMA teams generating and disseminating evidence, supporting market registration, access, and adoption. A key activity is to support medical education to internal and external stakeholders, and commercialization activities. Tasks / Duties / Responsibilities INTERNAL PROCESS SUPPORT Work with cross-functional partners, including but not limited to R&D, Clinical Affairs, Regulatory Affairs, Health Economics & Market Access (HEMA) and Marketing to provide leadership with product development and commercial plans to support product launch, training content and delivery. Provide medical/surgical/scientific insights into design requirements, concept and prototype testing. Provide input into risk management processes for hazard/harm identification & risk mitigation. Assess device performance, including clinical benefits and safety profile, to evaluate the appropriate Risk-Benefit balance to support market registration and throughout life cycle. Work with Medical Safety and Post-Market Surveillance to assess, analysis and interpret events, complaints, signals and trends from clinical studies, literature, complaints, etc. Provide medical/surgical/scientific support for external regulatory inspections and audits, and internal audits. Provide expertise to support addressing complex medical information requests. Provide physician perspective, advice, guidance, and expertise as a medical expert for non-MD colleagues in medical affairs in matters requiring escalation or medical consultation. Provide expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications. Provide medical/surgical/scientific criteria in claims and collateral material review/approval. LIFE CYCLE MANAGEMENT (LCM) SUPPORT Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups. Research, prepare and document responses to Medical Information Requests from Healthcare providers; review and approve medical content in Copy Approval process; and consults with Franchise Medical Director when needed. S/he will provide consultation in support of literature review, analysis and conclusions for Clinical Evaluation Reports (CER) and provide review of CERs and assists in preparation of periodic safety reports for assigned products. Assist in reviewing risk evaluation (PRE or PRA) documents. INSIGHT MANAGEMENT AND BUSINESS DEVELOPMENT SUPPORT Engage with omni-channel external sources of information (key opinion leaders, medical societies, literature, social media, etc.) to capture, assess, and translate opportunities of unmet patient and provider needs and trends in the medical/healthcare ecosystems. Support business leaders by providing medical and scientific expertise and omni-channel insights to help shape optimal business development strategy and targets , including product launches, key scientific meetings, relationship management with leading research physicians, critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required. Validate Target Product Profiles across the assigned innovation pipeline, including gathering and assimilating input from Medical Affairs leaders across key markets. Provide strategic medical support for operating companies with no dedicated medical affairs personnel (and as requested for those companies with medical teams) including to help drive global innovation agenda through leadership and partnership with the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory, Clinical, Quality, & Supply Chain leveraging deep medical expertise. EVIDENCE GENERATION SUPPORT Assist medical evidence generation leaders to develop and execute global strategies for evidence generation for new and existing products, including medical interpretation of clinical analyses, and in the review and approval of clinical study reports and scientific articles (abstracts, manuscripts, etc), in order to support regulatory approval/clearance, health technology assessment, customer access, medical safety and post-marketing support. Requirements Required Minimum Education: MD or equivalent Completion of an accredited orthopedic surgery residency and a minimum 1-year fellowship in joint arthroplasty, spine surgery, and/or orthopedic sports medicine surgery is required. Candidate must have a minimum of 10 years relevant surgical experience (beyond initial licensure) including clinical practice, dedicated research, or other related training/experience. Experience leading in medical affairs, clinical development, or related roles in research / medical device industry is preferred. Strong understanding of clinical trends and the related healthcare market environment, with deep connections in the digital-, med tech- ecosystem Background and medical expertise in assessment of clinical risk-benefit throughout product development and life-cycle management, with deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc. Ability to be strong advocate for patient-centric decision making. Demonstrated ability to build successful relationships & develop partnerships with key business stakeholders & externally with regulators, investigators, etc. Strong business acumen US Board Certified Preferred 15% Travel Domestic and/ International Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ******************************** ) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : The anticipated base pay range for this position is 194000 to 334650 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. • Please use the following language: • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • This position is eligible to participate in the Company's long-term incentive program. • Employees are eligible for the following time off benefits: • Vacation - up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. *********************************************
    $176k-252k yearly est. 5d ago
  • Medical Director

    Med First Primary & Urgent Care 4.1company rating

    Raleigh, NC jobs

    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.
    $169k-263k yearly est. 2d ago
  • Medical Science Liaison - Rocky Mountain - Oncology

    EPM Scientific 3.9company rating

    Denver, CO jobs

    A clinical-stage biopharmaceutical company focused on developing innovative therapies in oncology and immunology. The organization is committed to advancing science and improving patient outcomes through a robust pipeline and strategic medical engagement. Position Summary The MSL/Field Medical Director serves as a key field-based representative of the Medical Affairs team, responsible for scientific exchange, clinical education, and research support across a defined geographic territory. This role is non-promotional and centers on building peer-to-peer relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), and clinical investigators. The FMD plays a critical role in executing medical strategy, gathering field insights, and supporting clinical development initiatives. Key Responsibilities Scientific Engagement & External Stakeholder Support Serve as the primary clinical/scientific resource for HCPs and KOLs within the assigned region. Provide high-quality, balanced, and timely scientific information on disease states and company products/pipeline. Facilitate scientific exchange and maintain relationships with external experts in relevant therapeutic areas. Deliver clinical and scientific presentations in accordance with regulatory and compliance guidelines. Capture and communicate field insights to internal stakeholders to inform strategy and development. Respond to unsolicited medical information requests in the field. Support pharmacovigilance activities per company SOPs. Collaborate with leadership to develop and execute a regional medical plan. Lead or contribute to special projects such as training, advisory boards, and internal education initiatives. Training & Internal Education Maintain deep scientific and clinical expertise in oncology and other relevant therapeutic areas. Stay current on competitive landscape, clinical practice trends, and study methodologies. Support internal teams (e.g., commercial, clinical development) with scientific training and education as needed. Research & Clinical Trial Support Support investigator-initiated research and HCP-led data generation projects. Assist in the review and follow-up of submitted IITs. Collaborate with clinical operations on company-sponsored trials, including site selection and initiation activities. Communicate site-level insights to internal teams to support trial execution and strategy. Professional Organization & Advocacy Engagement Partner with internal colleagues to build relationships with professional societies, advocacy groups, and large clinical networks. Support medical affairs initiatives such as publications, advisory boards, and medical education programs. Health Economics & Outcomes Research (HEOR) Collaborate with Market Access and Medical Affairs to engage decision-makers and support evidence generation. Identify treatment pathways and opportunities for real-world data collection. Present scientific and value-based information to healthcare decision-makers (e.g., MCOs, PBMs, IDNs) when appropriate. Qualifications Education & Experience Advanced degree in a medical or scientific field (MD, DO, PharmD, PhD, NP, PA preferred). Minimum 8 years of relevant experience in oncology, immunology, or related therapeutic areas. At least 5 years in a field-facing medical role (e.g., MSL, FMD) within pharma or biotech. Experience in solid tumors preferred; GU and lung cancer experience strongly preferred. Clinical trial experience required. Valid driver's license required. Territory: MT, ID, UT, WY, CO, ND, SD, NE, KS, MO, and IA Skills & Competencies Strong knowledge of clinical research, treatment guidelines, and regulatory frameworks. Excellent communication, presentation, and interpersonal skills. Ability to build and maintain relationships with external stakeholders. Proven ability to work cross-functionally and independently. Strategic thinking and problem-solving skills. Proficiency in Microsoft Office and CRM/insights tracking systems. Commitment to compliance and teamwork within Medical Affairs. Compensation Entry-Level: $207,000 Highly Experienced: $240,000
    $207k-240k yearly 3d ago
  • Associate Director, Clinical Operations

    EPM Scientific 3.9company rating

    Boston, MA jobs

    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!
    $145k-215k yearly 4d ago
  • Hematologist Oncologist - Mary Bird Perkins Cancer Center

    Mary Bird Perkins Cancer Center 3.2company rating

    Alexandria, LA jobs

    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!
    $37k-72k yearly est. 1d ago
  • Regional Medical Affairs Director - Gulf Coast

    Xeris Pharmaceuticals 4.2company rating

    Remote

    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 and supporting 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.
    $170k-225k yearly Auto-Apply 4d ago
  • Veterinarian Medical Director - Exotics & Avian

    Alliance Animal Health 4.3company rating

    Windham, NH jobs

    Are you a veterinarian who's reliable, driven, and passionate about medicine-and ready to lead with purpose? At Canobie Lake Veterinary Hospital, we see you. We're the 2024 AAHA Hospital of the Year, and we're looking for a Medical Director who's excited to shape a thriving, multi-species practice while mentoring an incredible team. We believe leadership should feel empowering, not exhausting. You'll have strong support (1:7 ratio), advanced tools (digital rads, ultrasound, in-house lab), and the autonomy to practice excellent medicine-your way. What You'll Get: * Competitive salary + sign-on bonus + relocation + student loan help * Paid CE, mentor network, and future ownership opportunities * Full medical/dental/vision, 401K, pet discounts * Flexible scheduling and time to actually enjoy your life What You Bring: * A great attitude, strong work ethic, and growth mindset * Experience in general practice with exotics/avian (preferred) * Leadership skills and a passion for mentoring others This is your chance to lead a top-tier hospital-with heart. Let's talk about your goals and how we can help you reach them. Windham, NH | 40 min to Boston | No income or sales tax Job Description * Full-Time Medical Director Veterinarian * Proficient in general medicine, surgery and dentistry among a variety of species, with avian and exotics preferred as the primary species * Strong leadership qualities and ability to mentor and guide new veterinarians * Staff management, client relations, medical quality assurance and oversight of the practice Qualifications * Doctor of Veterinary degree, or equivalent, from an accredited university * Active veterinary state license * Current DEA License preferred but not required * USDA Accreditation preferred but not required Additional Information WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin
    $177k-260k yearly est. 1d ago
  • Medical Director

    Newport County Community Mental Health Center 3.7company rating

    Middletown, RI jobs

    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.
    $210k-296k yearly est. 60d+ ago
  • Regional Medical Affairs Director - Great Plains

    Xeris Pharmaceuticals, Inc. 4.2company rating

    Denver, CO jobs

    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 Denver, CO or St. Louis, MO or Minneapolis, MN** **Territory covers: WY, CO, NM, ND, SD, NE, KS, MN, IA, MO, IL, IN** **Responsibilities** + Fostering mutually collaborative relationships with institutions, Centers of Excellence, thought leaders (TLs) and key decision makers across the healthcare ecosystem in the areas of medical, education, clinical research, and real world experience. + Provide medical information through scientific exchange in a fair-balanced manner and clinical/scientific support as identified or requested in addressing the informational needs of the healthcare community, as well as responding to unsolicited requests for pipeline or off-label information. + Delivering medical presentations to diverse healthcare professional (HCP) audiences including healthcare decision makers, professional medical societies, and identified advocacy groups. + Providing scientific and liaison support related to Xeris clinical research activity, including thought leader and investigator engagement and follow-up, and facilitation of unsolicited requests for interactions related to Investigator Initiated Studies (IISs). + Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and medical support within Medical Affairs, Clinical Development, Commercial, and other internal stakeholders, etc. + Obtaining, assimilating, organizing, and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable Xeris policies, procedures, and processes + Attending & participating in medical/scientific meetings and conferences for the purpose of gaining scientific insights, collecting emerging scientific data, identifying healthcare trends, and supporting the scientific exchange and communication related to Xeris therapeutic areas of interest and research & development + As identified, contribute to internal training for headquarter- and field-based teams andsupporting speaker training initiatives. + Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all Xeris policies, procedures, and processes. + Maintain clinical/scientific expertise and providing strategic insights into emerging scientific data and healthcare trends. + Collaborating with TLs and Xeris Medical Communications to support the development of appropriate publications and related medical communications. + Participate in assigned Medical Affairs projects, initiatives, and activities as identified and requested. + Performing and completing administrative responsibilities, including reporting requirements in a timely fashion **Qualifications** + Advanced degree (MD, PhD, PharmD, DNP) in a related discipline strongly preferred + Less than 2 years of experience [Entry level as Associate Director]; 2+ years of experience [Entry Level as Director] of previous Field Medical or Medical Affairs pharmaceutical industry [post-doctoral pharmaceutical industry training via residency or fellowship also welcomed] + Active clinical care, clinical research, or academia experience preferred + Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care. + Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution + Extensive knowledge of Endocrinology, including Cushing's Disease and field medical affairs is strongly preferred. + Competencies:Customer Service focus, Teamwork & Collaboration, Written and Verbal Communication skills, Presentation skills, Time Management skills, Self-Starter. + Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.Approximately 60% overnight travel _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-REMOTE _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $170,000 to $225,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US_ **Title** _Regional Medical Affairs Director - Great Plains_ **ID** _2025-2266_ **Category** _Medical Affairs_ **Type** _Full-Time_
    $170k-225k yearly 46d ago
  • Regional Medical Affairs Director - Gulf Coast

    Xeris Pharmaceuticals, Inc. 4.2company rating

    Houston, TX jobs

    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_
    $170k-225k yearly 46d ago
  • Regional Medical Affairs Director - Southwest

    Xeris Pharmaceuticals, Inc. 4.2company rating

    Dallas, TX jobs

    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_
    $170k-225k yearly 46d ago
  • Veterinarian Medical Director

    Alliance Animal Health 4.3company rating

    Los Angeles, CA jobs

    Eagle Rock Pet Care is an established clinic that understands the deep bond between pets and their owners. We are located in Eagle Rock, CA and excited to be hiring a Medical Director to join our team! At Eagle Rock Pet Care, we're all about creating a place where you feel supported, valued, and excited to come to work every day. We see a wide variety of cases-including exotics-so there's always something new to learn and opportunities to grow. Here, you'll find a team that genuinely cares about helping each other thrive and making a difference for our patients. If you're looking for a welcoming, ambitious practice where learning is part of the daily routine, we'd love to meet you. Why choose us? * Practice Type: General Practice/Small Animal clinic with some exotics * Excellent Benefits: OFFERING SIGN-ON BONUS, RELOCATION ASSISTANCE, STUDENT LOAN ASSISTANCE, FUTURE OWNERSHIP OPTIONS, ETC.! * Medical Autonomy: Shape the future of this clinic, your way! Services Include: Routine Care, Surgery, In-House Diagnostics, Ultrasound, EKG, Exotics Care, and more. Learn More About Our Hospital! Check out our website here! Eagle Rock, CA is a historic neighborhood located in the Northeast Los Angeles area. It is the perfect blend of laid-back neighborhood charm and access to everything Los Angeles offers. Enjoy lazy afternoons hiking Griffith Park or catching a show at the Hollywood Bowl. Shop and dine at The Grove, explore art in Pasadena, or unwind on Santa Monica's beaches-all just a short drive away. Explore all Eagle Rock has to offer! Job Description * Part Time or Full Time Veterinarian * Proficient in general medicine and surgery Salary Range can vary from $150,000 to $200,000. Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate. We offer our veterinarians: * Flexible Scheduling & Medical Autonomy * Comprehensive Benefits (paid vacation/sick time/holidays, health, dental, vision, liability, 401K, life & supplemental insurance, employee assistance program & personal pet care discounts) * Future Ownership Opportunities * Competitive Compensation * DVM Mentor Network * Paid CE Allowance & Professional Dues Qualifications * Doctor of Veterinary degree, or equivalent, from an accredited university * Active veterinary state license * Current DEA License * USDA Accreditation * Strong leadership skills Additional Information WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin
    $150k-200k yearly 1d ago
  • Medical Director Veterinarian

    Alliance Animal Health 4.3company rating

    Crete, IL jobs

    The Gist of the Role Looking for a change of scenery? We're looking for a Medical Director DVM to join our rustic practice found just a commutable stone's throw away from Chicago. Our charming red barn setting offers a peaceful escape from the bustling city yet is still conveniently close by. With flexible scheduling, you can enjoy a healthy work/life balance (AKA: work, then catch a show in Chicago!) Our compassion-driven culture promotes medical autonomy, allowing you to practice veterinary medicine on your own terms. Plus, our Partner Track program offers ownership opportunities and flexibility to invest in your medical interests. Join our team and experience the satisfaction of making a meaningful impact on the lives of pets and their owners while building a successful and fulfilling career. Job Description More About Our Practice Plum Creek Animal Medical Center is a well-established, progressive, fast-paced 3 doctor small animal practice with a nearby outpatient clinic. We are proud to be a 25-year AAHA-Certified hospital. Plum Creek offers many services to supply the best comprehensive care to our patients including Wellness and Preventive Care, Illness, Problem and Urgent Care, Surgery, Dentistry, Therapeutic Laser Therapy, In-House Diagnostics, Digital full body and dental radiology, Ultrasonography, Acupuncture, Medical and/or Vacation Boarding and more. Our charming red barn setting supplies the perfect escape from the hustle and bustle of Chicago while still being close to the city. We highly value work-life balance and offer flexibility on scheduling, so you can enjoy your personal life without sacrificing your career. Our limited-service outpatient clinic provides doctors and staff with the ability to enjoy variety while the records and clients are shared between locations. You're here for pets, we're here for you. * Flexible scheduling for work-life balance * Medical autonomy to practice medicine your way * Future ownership opportunities * Just a short distance from Chicago * Extremely generous signing bonuses * Full benefits - PTO, health/dental/vision/life insurance, 401K, pet care discounts, etc. * Competitive compensation * DVM mentor network * Paid CE allowance & professional dues * Also offering relocation assistance and student loan aid * Commuter stipend for gas/tolls if needed We're Looking For * Full time veterinarian- Medical Director * Compassionate, team player and strong communicator * Proficient in general medicine and surgery * Experience preferred but new graduates seeking mentorship are encouraged to apply! #IND5 Qualifications * Doctor of Veterinary degree, or equivalent, from an accredited university * Current DEA License or obtained upon hire * Active Veterinary State License * USDA Accreditation or obtained upon hire Salary Range can vary from $100,000 to $150,000. Determining factor is solely based off experience, qualifications, schedule, compensation structure, and is subjected to change per applicable candidate. Additional Information Hiring eligibility may be contingent to a candidate authorizing and completing a satisfactory background check. WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin
    $100k-150k yearly 1d ago
  • Executive Medical Director, Patient Safety (Hybrid)

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    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
    $125k-173k yearly est. Auto-Apply 60d+ ago
  • Senior Director, Medical Writing

    Ironwood Pharmaceuticals 4.7company rating

    Boston, MA jobs

    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
    $239k-278.6k yearly Auto-Apply 32d ago
  • Senior Medical Director - Medical Safety Evaluation

    Mitsubishi Tanabe Pharma America 4.1company rating

    Los Angeles, CA jobs

    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:
    $109k-204k yearly est. 60d+ ago
  • Senior Medical Director - Medical Safety Evaluation

    Mitsubishi Tanabe Pharma 4.1company rating

    Jersey City, NJ jobs

    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:
    $103k-175k yearly est. Auto-Apply 60d+ ago
  • Senior Medical Director - Medical Safety Evaluation

    Mitsubishi Tanabe Pharma America 4.1company rating

    Jersey City, NJ jobs

    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:
    $103k-175k yearly est. 2h ago
  • Associate Director/Director, Medical Writing

    Incyte 4.8company rating

    Wilmington, DE jobs

    Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Director, Medical Writing is responsible for the medical writing activity within a portfolio of programs. Ensures oversight of the development of the clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. While partnering with the Head of Medical Writing, ensures the deliverables are resourced, any issues are escalated, and the strategic direction of the clinical documents for submission to regulatory authorities globally is sound. Keeps abreast of the clinical development of each of the compounds within the programs assigned and has functional understanding of global regulatory document standards. May have direct people management responsibilities. Reports to a Director of Medical Writing or above, and, if a people manager, is a member of the Medical Writing Leadership Team contributing to the strategic direction of the department. Essential Functions of the Job (Key responsibilities) Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, as well as Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives. Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for assigned programs/compounds. Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents. Lead or participate in cross-functional process improvement initiatives. Serve as a subject matter expert (eg, document type, process, technology). Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents. Oversee contract medical writing resources as required to ensure timely completion of assigned projects, which may include defining and reviewing of scopes of work (content and financial) within the assigned programs. May have direct people management responsibility of writers including providing mentoring and facilitating employee professional development. Serve as a member of the Medical Writing Leadership Team, if a people manager, helping to define the strategic direction and process improvements both within MW and cross-functionally. Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred. More than 10 years medical writing experience in the biopharmaceutical/CRO industry required. Demonstrated ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical team. Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups. Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment. Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired. Demonstrated ability to independently lead the clinical portions of a marketing authorization submission including the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach. Proficient in MS Word. Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types. Ability to interact effectively with team members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (including problem solving and issue resolution). If direct people manager, prior management experience preferred. Ability to manage people and provide active support in all aspects of the job. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.
    $151k-228k yearly est. 60d+ ago
  • Associate Director/Director of Medical Engagement

    Esperion Therapeutics Inc. 4.1company rating

    Ann Arbor, MI jobs

    Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays. Position Title: Associate Director/Director of Medical Engagement The Associate Director/Director of Medical Engagement will represent Esperion's commitment to advancing patient care and scientific innovation by engaging with healthcare professionals, researchers, and key stakeholders to deliver scientific information, identify insights, and establish long-term partnerships. These roles reflect a progression of responsibilities, with the Associate Director role focusing on functional area leadership and the Director role encompassing strategic leadership, cross-functional collaboration, and direct field team management. Ideal candidate will be based in the Boston, MA area. Territory: Upstate NY, CT, RI, MA, VT, NH, and ME Essential Duties and Responsibilities* Engage with Thought Leaders (TLs): Build and maintain trusted relationships with healthcare professionals, academic centers, and researchers aligned with Esperion's mission. Scientific Exchange: Deliver and discuss current and emerging scientific data on hypercholesterolemia, ensuring high-quality educational interactions with external stakeholders. Clinical and Scientific Expertise: Develop expertise in cardiometabolic and lipid-related science, Esperion's product portfolio, and emerging clinical trends. Strategic Insight Capture: Gather field insights on unmet needs, treatment landscapes, and competitive intelligence to refine Esperion's strategies. Congress and Event Participation: Represent Esperion at medical congresses, roundtable discussions, advisory boards, and educational programs. Cross-Functional Collaboration: Partner with internal teams as appropriate, including Market Access, Marketing, Clinical Development, Regulatory, to align scientific and commercial strategies. Compliance: Ensure adherence to all corporate policies, U.S. healthcare laws, and industry regulations in all scientific engagements. *Additional duties and responsibilities based on level as assigned such as: Associate Director: Lead scientific initiatives within the functional area, including internal and external projects. Mentor and guide MSLs as appropriate, fostering professional development within the team. Contribute to Medical Affairs strategy development for congress planning, scientific publications, and real-world evidence initiatives. Collaborate on the development of health system quality improvement initiatives. Serve as a subject matter expert in cardiometabolic care, providing advanced scientific guidance to internal and external stakeholders. Ensure compliance with corporate policies, U.S. healthcare laws, and industry regulations in all scientific engagements. Director: Lead strategic external engagement with Integrated Delivery Networks (IDNs), health systems, and high-level stakeholders to establish long-term partnerships. Develop and execute long-term strategies for partnerships and scientific initiatives that align with Esperion's mission. Lead and coordinate cross-functional teams to ensure alignment of scientific, clinical, and commercial objectives in an appropriate and compliant manner. Champion high standards of compliance, ethics, and patient safety across all scientific and medical activities. Field Team Management: Provide leadership, mentorship, and performance oversight for field-based medical engagement teams, including MSLs and ADs, ensuring a positive and collaborative culture. Qualifications (Education & Experience) Advanced degree required (MD, PhD, PharmD, or equivalent); NP or PA with relevant experience may be considered. Associate Director: At least 5+ years of relevant experience, including leadership or mentoring responsibilities. Director: At least 8+ years of pharmaceutical or clinical experience, including leadership roles managing teams and external stakeholder engagement. Director: Proven ability to develop and execute long-term strategic initiatives Director: Strategic vision with cross-functional leadership and team management capabilities. Demonstrated ability to lead functional area projects and initiatives. Expertise in cardiovascular, cardiometabolic, or lipidology required. Strong scientific knowledge and ability to communicate complex medical concepts to diverse audiences. Exceptional communication and interpersonal skills to build trust and credibility with stakeholders. Analytical mindset with attention to detail and problem-solving capabilities. Adaptability to thrive in a fast-paced, dynamic environment with competing priorities. Demonstrated leadership and ability to manage functional area initiatives while mentoring others. Outstanding organizational, planning, and project management skills. Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and CRM software. Valid U.S. driver's license with the ability to travel >50% (including overnight travel).
    $159k-237k yearly est. Auto-Apply 60d+ ago

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