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Medical director jobs in New Jersey - 627 jobs

  • US Medical Director - Neuromuscular and Neurodegenerative Diseases

    Sanofi 4.3company rating

    Medical director job in Morristown, NJ

    The US Medical Director - Neuromuscular and Neurodegenerative Diseases leads medical strategy and thought leader engagement for Sanofi's neurology portfolio, including Riliprubart. This role involves cross-functional collaboration to support clinical development, product strategy, and medical education within the pharmaceutical industry. The position requires an MD, PhD, NP, or PharmD with expertise in neurology and experience in biologics or clinical care. Job Title: US Medical Director - Neuromuscular and Neurodegenerative Diseases Location: Cambridge, MA / Morristown, NJ About the Job Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn This leadership position reports to the Head of North America Neurology Medical, offering an opportunity to work in a patient-centric, high-performance culture. The role combines support for Sanofi's MS portfolio with primary responsibility for medical leadership of Riliprubart and other neurology pipeline assets in neuromuscular and neurodegenerative diseases. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities Strategic Leadership Lead US Neurology Medical activities related to Riliprubart and other pipeline assets addressing unmet needs in neuromuscular and neurodegenerative diseases Develop and execute the annual US Medical Brand Plan aligned with critical success factors Identify unmet medical needs in neuromuscular and neurodegenerative diseases addressable by Sanofi assets Thought Leader Engagement Cultivate relationships with current and future experts in MS, neuromuscular and neurodegenerative diseases across US academic and clinical medicine Develop and implement KOL management plans with the cross-functional team Gather expert insights to influence Clinical Development and Life Cycle Planning strategies Product Strategy & Support Collaborate with the cross-functional team to define and refine branded product strategy Work with Clinical, Global Medical/Scientific Communications, Pharmacovigilance, and Statistics teams on post-hoc analyses and benefit/risk profile refinement Support communication strategies for company-generated data in collaboration with Global Medical Scientific Communications Cross-Functional Collaboration Provide medical support, education, and guidance to Commercial, Marketing, Sales, and Market Access teams Liaise with Global and US Neurology Medical Directors to ensure alignment across the organization Participate in Medical Affairs, Clinical Sciences & Operations, and cross-functional teams and committees About You Qualifications Education & Experience MD, PhD, NP, or PharmD required 2+ years relevant experience in biologics/pharmaceutical industry OR relevant clinical experience. Expertise in neuromuscular and neurodegenerative diseases, multiple sclerosis, and/or neurology preferred Experience in both clinical development and patient care preferred Professional Skills Outstanding scientific acumen Strong leadership and analytical skills with ability to deliver on project objectives Proven ability to lead and influence teams without direct authority Excellent communication, presentation, and organizational skills Self-directed with ability to work independently with minimal direction Collaborative and transparent leadership capabilities Creative and innovative thinking Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Keywords: Medical Director, Neuromuscular Diseases, Neurodegenerative Diseases, Pharmaceutical Industry, Clinical Development, Medical Leadership, Neurology, Product Strategy, Key Opinion Leader, Healthcare Management
    $211k-300k yearly est. 2d ago
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  • Regional Medical Director

    Boldage Pace

    Medical director job in Oceanport, NJ

    Join BoldAge PACE and Make a Difference! Why work with us? A People First Environment: We make what is important to those we serve important to us. Make an Impact: Enhance the quality of life for seniors. Professional Growth: Access to training and career development. Competitive Compensation: Medical/Dental Paid Time Off 240 Hours Annually 401K with Match Life Insurance Tuition Reimbursement Flexible Spending Account Employee Assistance Program BE PART OF OUR MISSION! Are you passionate about helping older adults live meaningful, independent lives at home with grace and dignity? BoldAge PACE is an all-inclusive program of care, personalized to meet the individual health and well-being needs of our participants. Our approach is simple: We listen to our participants and their caregivers to truly understand their needs and desires. Medical Director JOB SUMMARY: The Medical Director provides general medical direction and supervision of the medical aspects of care for participants. The Medical Director is responsible for the delivery and oversight of participant care, clinical outcomes, implementation and oversight of the quality assessment and performance improvement program, development and maintenance of medical policies and procedures/standards and protocols. The Medical Director will provide direction and supervision to primary care physicians, nurse practitioners, nursing staff and allied health services and leadership of the program among staff, colleagues and providers in the community. Any PCP Nurse Practitioners will practice collaboratively with the Medical Director or PCP Physician. Responsible for ensuring a managed care environment that utilizes resources efficiently and effectively. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for delivery of care and clinical outcomes. Provides medical guidance and supervision of medical services activities. Provides leadership and medical expertise in the development of medical policies, procedures and guidelines. Responsible for the development of PACE clinical standards and medical practice guidelines and protocols. Provides oversight of the QI Plan. Reviews all quality-of-care issues and oversees the development and implementation of quality of care corrective action plans. Participates in the oversight, training and education of the interdisciplinary team. Coordinates performance appraisal of the Primary Care Physician. Develops educational and other programs to build the skills of participating providers. In conjunction with Contract Manager manages all communication with the provider network Represents PACE to external agencies, professional groups and regulatory agencies and organizations as required. Demonstrates necessary skills and knowledge as outlined in position-specific competency requirements. REQUIREMENTS: M.D. or DO with current state of license. DEA registration and the ability to obtain and maintain staff privileges at PACE contracted agencies. Board certified in Internal Medicine or Family Practice with advanced certification in geriatrics preferred. Must have experience working in a managed care environment and working with peers and other health providers to resolve utilization, quality management, performance improvement, pharmacy and therapeutics, peer review, credentialing, and physician leadership issues. Minimum 3 years of experience in a lead administrative role. 1 year of experience working with a frail or elderly population preferred. If this is not present, training on working with a frail or elderly population will be provided upon hiring. Must have reliable transportation, a valid driver's license, and the minimum state required liability auto insurance. Be medically cleared for communicable diseases and have all immunizations up to date before engaging in direct participant contact. Pass a comprehensive criminal background check that may include, but is not limited to, federal and state Medicare/Medicaid exclusion lists, criminal history, education verification, license verification, reference check, and drug screen. SKILLS AND ABILITIES: Excellent verbal, written and public speaking skills. Knowledge of physical, mental and social needs of frail older adults. Effective skills in physical assessment and chronic disease management for frail older adults. Able to work within the interdisciplinary team setting. Able to utilize basic computer skills in the workplace. Strong organizational skills. Demonstrates necessary skills and knowledge as outlined in position-specific competency requirements. Dependable, flexible and resourceful Able to work effectively and in a collegial manner will all members of the management and medical staff. Able to work sensitively and effectively with individuals of diverse ethnic and cultural backgrounds. BoldAge PACE provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Paid Time Off Includes seven holidays Match begins after one year of employment Full-Time Days Full- Time
    $169k-262k yearly est. 2d ago
  • Family Medicine Residency Program Director/Medical Director

    Hackensack Meridian Health 4.5company rating

    Medical director job in Edison, NJ

    Hackensack Meridian Health is seeking an experienced, visionary, and passionate Program Director / Medical Director to lead the Family Medicine Residency Program at JFK University Medical Center. This is an outstanding leadership opportunity for a dedicated physician committed to academic excellence, clinical innovation, and the training of the next generation of family medicine physicians. Position Overview: The Program Director will provide strategic and operational leadership for the Family Medicine Residency Program, ensuring full compliance with ACGME and institutional requirements. This role is responsible for cultivating a supportive and academically rigorous learning environment, fostering faculty development, and ensuring the continued success of the program. As Medical Director of the Family Medicine Center, the selected physician will oversee day-to-day clinical operations, quality and safety initiatives, and patient care processes aligned with Joint Commission and NCQA Patient-Centered Medical Home standards. The Medical Director will serve as a role model for compassionate, evidence-based care, and an advocate for both patients and staff. Key Responsibilities: Provide strategic leadership and direction for the Family Medicine Residency Program in collaboration with department and institutional leadership. Oversee the design, implementation, and evaluation of the residency curriculum, ensuring alignment with ACGME milestones and competencies. Recruit, mentor, and develop residents and faculty to foster excellence in teaching, research, and clinical practice. Ensure continuous program improvement through data-driven assessment, scholarly activity, and adherence to accreditation standards. Direct and support quality improvement initiatives to enhance patient outcomes, safety, and satisfaction. Maintain clinical engagement (approximately 20% clinical time) providing high-quality, patient-centered care within the Family Medicine Center. Oversee compliance with institutional, state, and federal regulations related to residency education and clinical operations. Collaborate with health system leadership on strategic planning, budgeting, and staff development initiatives. Promote diversity, equity, and inclusion within the residency program and clinical environment. Qualifications: MD or DO degree with Board Certification in Family Medicine (ABFM or AOA). Minimum of 5 years of progressive leadership experience in graduate medical education and clinical practice. Demonstrated expertise in curriculum development, faculty mentorship, and quality improvement initiatives. Proven ability to lead and inspire teams, manage complex academic programs, and drive innovation in medical education. Excellent communication, organizational, and interpersonal skills. Eligibility for medical licensure in New Jersey. HOW TO APPLY: Nancy Massa, Physician Recruiter Email: ******************** Phone: ************ (Call or Text) HMH is committed to pay equity and transparency for our team members. The minimum base salary for this position is $280,035. The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting base salary is provided for informational purposes only and is not a guarantee of a specific offer. The base compensation determined at the time of the offer may be different than the posted base salary based on a number of non-discriminatory factors, including but not limited to: Specialization: Area of specialization and sub-specialization. Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant experience in the areas of specialization and sub-specialization. Leadership: Relevant experience as a department chair or chief, practice group leader, or other leadership roles. Education and Certifications: Degrees attained, residencies, fellowships, board certifications, research, and publications. Productivity: Levels of productivity, quality and patient satisfaction. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the specialty and/or sub-specialty. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. In addition to our compensation for full-time and part-time (20+ hours/week) positions, HMH offers a comprehensive benefits package, including health, dental, vision, tuition reimbursement, and retirement benefits. The final compensation and benefits package will be discussed during the interview process.
    $280k yearly 3d ago
  • Clinical Director - Contract

    Pacer Staffing

    Medical director job in Ridgefield, NJ

    Job Title: Clinical Director Shift - 8 hours day Weekly hours : 37.5 Duration : 13 weeks Weekly Pay : $2583/Week for 36 hours Requirement NJ or compact RN License Experience At least 4 years supervisory experience in a home health care setting. Experience working with home health care standards and quality assurance or risk management. Acute care experience At least one year experience in high tech nursing.
    $2.6k weekly 1d ago
  • Clinic Director & Partner - Physical Therapist (Open your own clinic!)

    Ivy Rehab Network, Inc. 3.8company rating

    Medical director job in Phillipsburg, NJ

    State of Location: New Jersey Join Ivy Rehab 's dedicated team where you're not just an employee, but a valued teammate! Together, we provide world-class care in physical therapy, occupational therapy, speech therapy, and applied behavior analysis (ABA) services. Our culture promotes authenticity, inclusion, growth, community, and a passion for exceptional care for every patient. Job Description: Clinic Director & Equity Partner (Must be a Licensed Physical Therapist) Ivy Rehab Physical Therapy - Outpatient Ortho Location: We go where clinicians, patients, and strong relationships already are. We're open to exploring locations that best serve you and your community, and we want our partners to play a key role in choosing the clinic site. Please note that this clinic does not yet exist and would be a start-up location. Company Overview: Ivy Rehab is a leading national provider of outpatient ortho, pediatric, and ABA therapy services. We are a forward-thinking organization that invests in the professional and clinical development of our teammates. What sets us apart is our ability to cultivate a culture of autonomy, community, collaboration, and entrepreneurship. Fantastic track record of opening de novos and sustained profitability (over 370+ clinics successfully opened by clinicians just like you!). Why Partner with Ivy: Partnering with Ivy Rehab to open a clinic is appealing because it combines the benefits of ownership with the support of a large, established organization. Ivy Rehab offers strong brand recognition, access to capital, and comprehensive operational support (billing, HR, marketing, IT), reducing both financial and administrative burdens. Their proven clinical and business systems help new clinics grow faster, while their referral networks and payer relationships boost patient volume. Partners also gain professional development opportunities and the advantages of a shared-ownership model. Overall, it allows clinicians to focus on patient care while scaling more reliably than opening a clinic independently. Compensation Structure: Clinic Director Base Salary: $100,000 - $120,000 + competitive annual bonus plan + true equity ownership in the clinic (more skin in the game!) Full Benefits in Your First 30 Days: Medical, dental, vision 401k with a 14% match (2024!) Disability & life insurance Pet insurance Paid parental leave Gym discounts Free mental health + financial services Annual CEU allowance + 2 fully paid CEU days Up to 160 hours of PTO & 6 paid holidays annually How to be successful in this role: Entrepreneurial mindset with a drive to build and grow a successful clinic. Strong work ethic and determination to establish community presence and referral relationships. Licensed Physical Therapist in the state of practice. Minimum 2 years of clinical experience; supervisory experience preferred. Learn More: We are an equal opportunity employer, committed to diversity and inclusion in all aspects of the recruiting and employment process. Actual salaries depend on a variety of factors, including experience, specialty, education, and organizational need. Any listed salary range or contractual rate does not include bonuses/incentive, differential pay, or other forms of compensation or benefits.
    $100k-120k yearly 13h ago
  • Medical Director | AAHA-Accredited Practice | West Caldwell, NJ

    Blue River Petcare 3.9company rating

    Medical director job in West Caldwell, NJ

    Looking for a collaborative clinic, flexible scheduling, and no emergency hours? At West Caldwell Animal Hospital, we offer a supportive, family-focused team, and an ideal location just 25 miles from Manhattan. About Us * AAHA-accredited small animal hospital with 60 years of trusted care * Two-doctors and a tenured, experienced support staff * Located in West Caldwell, a safe suburb with excellent schools and NYC access What You'll Do * Define, implement, and promote practice medical policies and procedures that ensure quality patient care * Provide mentorship and high-quality medical and surgical care * Collaborate with a skilled veterinary team * Engage with a diverse client base in a growing community
    $173k-258k yearly est. 60d+ ago
  • Veterinary Medical Director

    Bluepearl 4.5company rating

    Medical director job in Paramus, NJ

    If you are a current associate, you will need to apply through our internal career site. Please log into Workday and click on the Jobs Hub app or search for Browse Jobs. BluePearl Pet Hospital located in Paramus, NJ is seeking a collaborative, engaged, and passionate veterinary leader with several years of clinical experience to lead our team of emergency and specialty clinicians in the role of Medical Director. The Medical Director will partner in leadership with hospital administration to create a sense of community and interact globally with the hospital and all clinicians. Using excellent communication and interpersonal skills, the Medical Director will support veterinary partner relationships and enhance an engaging work environment for all by making a positive impact on the culture while cultivating an environment where medical quality stands out. We offer a competitive salary and relocation assistance. The primary responsibilities of the Medical Director include upholding medical quality standards (patient care, client and referral veterinarian satisfaction, and patient safety), supporting quality and operational initiatives, fostering a clinician-driven culture and one that cultivates a learning environment, and clinician recruiting, engagement, and retention. The ideal applicant needs to be self-motivated, collaborative, and able to work harmoniously and effectively with other clinicians, staff and referring veterinarians. We have an incredible collaborative relationship with our referring veterinarians, so the right candidate must be willing to interact in a variety of ways including making personal visits to their practices, presenting CE programs, and discussing cases by phone. There is dedicated paid administrative time off the floor to allow for success in creating a positive impact. We are truly in this together. We work to provide exceptional specialty and emergency care for pets by supporting each other through our shared passion, knowledge, and talents. Our BluePearl Paramus hospital is a state-of-the-art facility that opened in September 2016. All of our specialists at this 19,000 square foot hospital focus on critical care, internal medicine, surgery, oncology, cardiology, emergency medicine and dentistry. Our current equipment includes a 64- slice CT scanner, ultrasound, fluoroscopy, ultrafiltration, laparoscope, thoracoscopy tower, endoscopy imaging system, prismaflex and phoenix machines. We also provide transesophageal echocardiography, dialysis, and blood banking. Our hospital fosters a collaborative, team-oriented environment that works together to make a difference. The staff are like family and participates in team-building events throughout the year including Veterinary Technician Week, potluck meals, birthday celebrations, Associate of the Month recognition and in-house CE programs. Over 80% of our technicians are licensed and some will be sitting for the boards in the upcoming year. Perks to Living in Paramus, NJ: New Jersey is a wonderful place to work and live! Between the high quality of life, top-notch healthcare and public education and great job market, residents are considered some of the happiest in the country. Paramus is a suburb of New York City with a population of 26,650 and is 22 miles from NYC. Paramus is known for its multitude of stores and malls. It has five major indoor shopping centers, serving residents in the areas of Bergen County and Passaic County in New Jersey and Rockland County in New York and is close to the Meadowlands Sports Arena (home of the NY Giants and Jets), Madison Square Garden and Prudential Center (home of the NJ Devils). Paramus is in Bergen County and is one of the best places to live in New Jersey. Living in Paramus offers residents a sparse suburban feel and most residents own their homes. In Paramus there are a lot of restaurants, coffee shops, and parks. Many retirees live in Paramus and residents tend to have moderate political views. The public schools in Paramus are highly rated. Why choose BluePearl? In order to transform and lead the industry through innovative quality medicine and care, we emphasize the importance of continuous learning. We offer annual continuing education allowance, free continuing education sessions, our own BluePearl University for training, and our clinicians have access to over 2,000 medical journals. Because we encourage Associate growth, you will be surrounded by a group of dedicated, experienced team members. All Associates are leveled by their skillset in our unique leveling program. We also focus on developing our Associates into leaders through talent development programs and leadership workshops. We value your health and well-being as an Associate by providing you with the following benefits: Comprehensive benefits package including medical, dental, vision, paid time off, parental leave, and floating holiday plans, 401(k) and life insurance options. Company-paid Short-Ter and Long-Term Disability Flexible work schedules. A regional licensed social worker who can provide guidance, advice, and tips/tricks on how to maintain a healthy lifestyle while working in a fast-paced emergency and specialty care environment. In addition, access to 12 mental health care sessions annually at no charge to you, and other well-being resources through Lyra, an online mental health support platform. Annual company store allowance. Trupanion pet insurance and discounts to our associates for pet treatments, procedures, and food. The future is yours to create. We have a wide array of opportunities and growth paths within the organization and within Mars Vet Health. Step up, stand out, get involved, and put your mark on our amazing profession! BluePearl is committed to a diverse work environment in which all individuals are treated with respect and dignity. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, creed, sex, age, disability, genetic information, marital status, citizenship status, sexual orientation or affectional preference, or gender identity or expression, protected veteran status, or any other characteristic protected by law. If you need assistance or an accommodation during the application process because of a disability, it is available upon request. The company is pleased to provide such assistance, and no applicant will be penalized as a result of such a request. We are an Equal Opportunity Employer and a Drug Free Workplace. Why BluePearl? Because it is an exceptional place to work!
    $149k-226k yearly est. Auto-Apply 60d+ ago
  • Global Brand Medical Director

    Artech Information System 4.8company rating

    Medical director job in East Hanover, NJ

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job DescriptionMedical Affairs leader for assigned compound(s) and /or project(s under the leadership of a Sr. GBMD or GMA Franchise head. Major Activities: For assigned compound/indications, work collaboratively across functions, within GPT to execute an integrated Medical Affairs plan including clinical trials, publication, medical education and medical information. Manages all operational aspects and drives execution for assigned projects of Global Medical Affairs clinical trials in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates. Participates and contributes to the joint ICT s. Provides Medical leadership to CTT s for Client sponsored GMA trials Leads review of investigator-sponsored trials and Local/Regional Medical Affairs trials concept sheets, within MRC, for assigned projects(s). Provides medical support for educational events (e.g. stand-alone meetings, scientific symposia) and scientific congresses within legal and compliance regulations. Collaborates across functions to achieve approval of key scientific communications, medical information documents and commercial documents within NP4 legal and compliance regulations. Skills: Fluent oral and written English. Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, Start-up, Execution, Analysis, Reporting). Have an excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area. Have strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products. 5 years experience in pharma at local, regional and/or Global level. Provide medical expertise to ensure successful product launches across functions. NVS sponsored trials Review and coordinate IITs Implement patient access programs Review promotional materials & publications Integrate medical expertise with commercial perspective. Maintain an external focus to optimize and maximize treatment options and compound life cycle management. Timely implementation and delivery of high quality Medical affairs clinical programs within budget, in full compliance with Client Standard and GCP/ICH. Well managed and effective clinical teams. External satisfaction, acceptability of clinical data by key decision makers including health authorities, payers. Development of high-quality scientific communications and medical information. Strong alignment between Global and Regional/local medical organizations. Strong alignment within global line functions. More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred. QualificationsEducation: MD Required More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred Additional InformationNeha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Website: ******************
    $182k-286k yearly est. 60d+ ago
  • Medical Director, Rheumatology / Dermatology Medical Strategy

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Medical director job in Trenton, NJ

    The Medical Director, Rheumatology and/or Dermatology Medical Strategy is a critical role responsible for shaping the strategic processes and planning for assets in early development (e.g., pre-Phase 3) within the Nephrology and Immunology portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Senior Director, Immunology Lead, who in turn reports to the Executive Director, Nephrology & Immunology Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across R&D, Clinical, Global Medical Affairs, and Early Commercialization functions + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the early Nephrology and Immunology portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to early assets **External Stakeholder Engagement** + Identify and engage Medical experts to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Medical Experts + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with Medical Experts to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to early assets **Cross-functional Integration & Planning** + Collaborate within the Nephrology & Immunology Medical Business Unit with the Nephrology & Immunology Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with expertise in **Rheumatology and/or Dermatology** + Preference for previous experience in Clinical Development, Research, or early-stage Medical Affairs + Expertise in Rheumatology or Dermatology is strongly preferred + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + \#LI-PG1 **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $209,599.00 - Maximum $313,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $209.6k yearly 36d ago
  • Medical Director - Edison, NJ

    Vetcor 3.9company rating

    Medical director job in Edison, NJ

    Who we are: Raritan Animal Hospital is seeking a dedicated and visionary Chief of Staff to lead our medical team and ensure the continued delivery of high-quality veterinary care. We are a thriving, community-centered practice consisting of a full-service main hospital supported by three outpatient clinics. This structure allows us to offer convenient access and continuity of care while maintaining the highest medical standards. We work closely with board-certified internal medicine, surgery, and cardiology specialists to provide advanced diagnostics and treatment options for our patients. Our facilities include: A well-equipped main hospital with modern amenities including an in-house labs, digital radiography, complete dental suite with dental radiography, newly renovated surgery suite with comprehensive monitoring systems and radiowave surgery A skilled, well-trained team of technicians who provide outstanding support to our doctors Beyond medicine, we're proud of our fun, inclusive, and community-focused culture. Our team enjoys events like Halloween costume contests, pictures with Santa, in-clinic egg hunts, and regular in-house CE opportunities that support ongoing learning and collaboration. What We're Looking For: Provide visionary oversight of all clinical care, ensuring outstanding patient outcomes and adherence to gold-standard medical practices. Champion new technologies and medical advancements to continually elevate our standard of care. Inspire and mentor associate and new graduate veterinarians through case collaboration and professional development. Foster a supportive and communicative team culture grounded in respect, collaboration, and growth. Cultivate strong client relationships with visibility, approachability, and excellent communication skills. Support initiatives that enhance client satisfaction, loyalty, and the hospital's well-earned reputation for compassionate care. What's in it for you: Vetcor offers a comprehensive benefits package that supports your well-being and professional growth. Enjoy medical, dental, and vision insurance, a 401(k) with company match, generous paid time off, CE allowance, paid parental leave, and access to a vast network of veterinary professionals. We also offer mental health support, employee discounts, and a culture that truly values work-life balance. Ready to connect? Email Kaley at *****************! Job Title: Chief of Staff Location: Raritan Animal Hospital Salary Range: $175,000 - $200,000 + Production Bonus (No Negative Accrual!) Our practice has a positive, well-being focused culture that we'd love to tell you about. Where we are: Edison, New Jersey is a vibrant, diverse township located in central New Jersey, just 30 miles from New York City. Known for its rich history-it's the home of Thomas Edison's famous Menlo Park lab-Edison offers a blend of suburban comfort, excellent schools, and easy access to major highways and public transit. With bustling shopping centers, parks, and a strong sense of community, it's a great place to live, work, and explore.
    $175k-200k yearly Auto-Apply 6d ago
  • Global Medical Affairs Director

    360 It Professionals 3.6company rating

    Medical director job in Madison, NJ

    360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description Accountable for deliverables of the Global Medical Affairs function, including expert review and evaluation of Benefits and Risk for RX to OTC switch products. Deliver Medical rationale, benefit/efficacy, core science summaries in support of Regulatory Submissions. Engage with external medical and scientific leaders in support of medical strategy. Skills: 1. Critical thinking in order to support application of scientific literature to solve 2. Ability to work on complex projects with highly-matrixed teams 3. Facilitate debate and conclusions to drive high quality, innovative project deliverables Additional Information Thanks and Regards, Isha Sharma 408-766-0000- EXT 425 isha.sharma@)usitsol.com
    $170k-259k yearly est. 60d+ ago
  • Associate Director, Medical Information, Oncology

    Eisai 4.8company rating

    Medical director job in Nutley, NJ

    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities · Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). · Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. · Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. · Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. · Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. · Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. · Liaise with global and regional medical affairs colleagues as appropriate. · Provide strong scientific support for conference and booth coverage. · Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. · Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. · Provide mentoring, guidance, and training to new hires/less experienced colleagues. · May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. Qualifications: · Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. · Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. · Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) · Practical experience and knowledge of FDA guidances on appropriate scientific exchange practices. · Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. · Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: · Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. · Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. · Strong understanding of data visualization and insights reporting to support strategic decision-making. · This role is hybrid in Nutley, NJ (in office every week on Tuesday, Wednesday, and Thursday) Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$162,600-$213,400Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
    $162.6k-213.4k yearly Auto-Apply 8d ago
  • Sr. Medical Director, Drug Safety and Pharmacovigilance

    Legend Biotech 4.1company rating

    Medical director job in Somerset, NJ

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance as part of the Clinical Development Team working in Somerset, NJ. Role Overview The Sr. Medical Director, Drug Safety & Pharmacovigilance is a critical role in the company with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Key Responsibilities Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals. Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information. Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings. Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects. Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)) Identification and management of Urgent Safety Measures with support of cross functional team. Overview, and/or author aggregate reports and signal evaluation reports for assigned projects. Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics. Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight. Oversee and manage internal safety scientist and safety operation team. Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals. Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.) Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed. Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership. Prepare/oversee monthly progress reports and ad-hoc reports as required Support process improvement and functional training at departmental & company level Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations Requirements MD or MBBS or MD-PhD or equivalent medical degree 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance. Strong understanding of pharmacovigilance regulations in the US and EU. Experience in supporting drug safety activities in registrational clinical studies High level of medical competence, with an ability to balance this with industry standards to achieve business goals Demonstrated skills in scientific analysis and reasoning. Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance. Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable Strong track record of delivering results through effective team and peer leadership in matrix Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.) Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. Experience in biotech - preferred but not required. #Li-LB1 #Li-Hybrid The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$285,906-$375,253 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.
    $105k-177k yearly est. Auto-Apply 2d ago
  • Senior Medical Director - Medical Safety Evaluation

    Mitsubishi Tanabe Pharma America 4.1company rating

    Medical director job in Jersey City, NJ

    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. 3d ago
  • Director of Medical Writing (NJ)

    Pathwayrp

    Medical director job in Montville, NJ

    EmTacq specializes in EM ployer T alent ACQ uisitions, matching the most qualified candidates with the most competitive positions available. We pride ourselves on not just putting bodies in seats, rather matching professionals to their careers. We are headquartered in the Raleigh / Durham, NC area. However, as a recruiting agency we service companies and candidates across the United States. We are your best source for professional, value driven low cost recruitment services. Our primary focus is providing a one-on-one recruiter relationship and provide top Direct hire performers to our clients. Our goal is to make each hiring experience simple and successful. We want to be your “Employment Partner" and are excited to assist you with all your employment needs. We look forward to building and maintaining a solid relationship. Our MISSION STATEMENT is to provide "Personnel Services with a Personal Touch". Our philosophy is to employ only the best, skilled candidates to create the perfect "fit" for each client. We follow that up with unsurpassed customer service. Job Description This medical writing expert role will assume overall responsibility for directing the development and implementation of the medical communication strategy for all regulatory submission documents for all assigned drug projects and work with assigned Senior Medical Writers and Submission team experts in developing and implementing the submission authoring strategy for all clinical sections. Qualifications An advanced Degree in Science 8+ years of experience in the pharmaceutical industry 6+ years of experience in regulatory medical writing involving all clinical document types in more than one therapeutic area. Must have experience in electronic document management and electronic regulatory submissions, tools and standards. Strong leadership experience and the ability to mentor Excellent verbal and written communication skills Some travel may be required. Additional Information Must be a US citizen or Green Card holder. All your information will be kept confidential according to EEO guidelines.
    $112k-216k yearly est. 3d ago
  • Associate Director Principal Medical Writer

    Sanofi 4.3company rating

    Medical director job in Morristown, NJ

    The Associate Director Principal Medical Writer leads the creation and management of high-quality regulatory-compliant clinical documentation supporting drug development. This role involves implementing innovative digital technologies, managing cross-functional projects, and mentoring junior writers to ensure compliance and efficiency. The position requires deep expertise in clinical development processes, regulatory requirements, and document management systems. Job Title: Principal Medical Writer Associate Director Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Document Development • Create high-quality regulatory-compliant clinical documents supporting product life cycle • Ensure timely delivery while maintaining compliance with standards Innovation • Lead implementation of new digital technologies and AI solutions • Drive process improvements for efficiency gains Regulatory Expertise • Prepare registration dossiers and Health Authority responses • Monitor and implement regulatory documentation requirements Project Management • Lead cross-functional initiatives as Subject Matter Expert • Drive change management within writing teams Communication • Update relevant stakeholders on project progress and needs • Maintain accurate information in planning, tracking, and reporting tools Ensure consistent communication across ClinDoc functions Coordination • Mentor junior writers and review contract work Quality & Training • Develop training programs and documentation standards • Build effective relationships with stakeholders and partners... About You Core Experience: Six+ years as medical writer or equivalent specialist role Proven track record leading multiple clinical documentation projects Expert in clinical documentation preparation Clinical Development Knowledge: Demonstrated expertise in clinical development processes Strong understanding of clinical study methodology and basic statistics Knowledge of regulatory environment Proficient in document management systems and authoring platforms Professional Attributes: Strong attention to detail and deadline management Excellent organizational and follow-up abilities Proven ability to work independently and in global teams Technical skills: • Expertise in electronic document management and Microsoft Office • Proven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Keywords: medical writer, clinical documentation, regulatory compliance, drug development, document management, clinical study methodology, regulatory writing, digital technologies, AI-assisted authoring, project management
    $189k-297k yearly est. 2d ago
  • Medical Director, Global Strategy Lead Rare Diseases - ALS

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Medical director job in Trenton, NJ

    The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $209,599.00 - Maximum $313,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $209.6k yearly 38d ago
  • Associate Director, Medical Information, Oncology

    Eisai Us 4.8company rating

    Medical director job in Nutley, NJ

    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities * Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). * Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. * Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. * Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. * Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. * Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. * Liaise with global and regional medical affairs colleagues as appropriate. * Provide strong scientific support for conference and booth coverage. * Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. * Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. * Provide mentoring, guidance, and training to new hires/less experienced colleagues. * May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. Qualifications: * Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. * Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. * Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) * Practical experience and knowledge of FDA guidances on appropriate scientific exchange practices. * Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. * Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: * Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. * Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. * Strong understanding of data visualization and insights reporting to support strategic decision-making. * This role is hybrid in Nutley, NJ (in office every week on Tuesday, Wednesday, and Thursday) Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$162,600-$213,400 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
    $162.6k-213.4k yearly Auto-Apply 8d ago
  • Senior Medical Director - Medical Safety Evaluation

    Mitsubishi Tanabe Pharma America 4.1company rating

    Medical director job in Jersey City, NJ

    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. 60d+ ago
  • Medical Director, Global Strategy Lead Rare Diseases - PKU

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Medical director job in Trenton, NJ

    The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $209,599.00 - Maximum $313,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $209.6k yearly 38d ago

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