Talent.com
Medical Director of Hematology - Remote
Medical Director of Hematology - RemoteNovartis Group Companies • East Hanover, NJ, United States
Medical Director of Hematology - Remote

Medical Director of Hematology - Remote

Novartis Group Companies • East Hanover, NJ, United States
9 days ago
Job type
  • Temporary
Job description

Job Description Summary

The Medical Director of Hematology develops and implements strategic and operational TAs Global Medical Affairs programs, with a focus on innovative evidence and / or launch readiness and / or post-market solutions, including medical affairs planning and execution of the medical / scientific engagement strategy addressing and delivering strategic pre-launch and launch medical activities needs for patient, clinical, access and value to health care systems. Provides expertise in the development and execution of the overarching strategies, providing inputs during design and along the end-to-end execution of programs. Develops and executes the Integrated Evidence Plan (IEP) / functional specific programs to maximize the value proposition for the prioritized launch portfolio and impact of our medicines.

  • Serve as US Medical Director for multiple global clinical development trials and / or US Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use).
  • Interface with the oncology therapeutic area Global and US Clinical Team Members, Clinical Operations, Scientific Operations, Regulatory Affairs, Drug Supply, Data Management, Finance, Quality, Compliance, and other relevant functional areas.
  • Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards including :

o Write and review protocols that are in-line with the overall indication strategy.

o Conduct medical review and interpretation of efficacy and safety data from clinical trials.

  • Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, clinical sections of INDs, Investigator Brochures, CTAs, ISS's, ISE's, clinical expert reports, and label reviews.
  • Review and provide US feedback to Global Protocols and Global Development Plans.
  • Develop strategy for US Medical Affairs including exploratory indications and integrate US plan with overall Medical Affairs strategy. Oversee the review and approval of IIT concepts. Oversight during the conduct of trials including safety monitoring. Review of interim and final publication, manuscripts, or abstracts.
  • Provide strategic input or develop strategy for US clinical trial programs. May also evaluate global strategy for the clinical trial programs.
  • May supervise and manage individuals on the US disease team as appropriate. Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
  • Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (i.e., IB, IND sections), for Company Sponsored project.
  • Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review.
  • Present and discuss data and findings at relevant internal and external meetings.
  • Ensure adherence to GCP / ICH and company Standard Operating Procedures (SOPs).
  • Where applicable, may lead disease area teams to :
  • o Ensure delivery of US medical tactical plan and development activities across all of a compound's related to the disease area, cost, time and quality.

    o Collaborate and work with other IMUS line functions for data gaps analysis, data generation activities, strategic congress management, strategic trial management, external stakeholder management and launch readiness plans.

  • Support and participate in FDA meetings including presentations, briefing books, and responding to FDA inquiries as needed.
  • Assist in the development and appropriate spending of clinical budget.
  • Extensive interactions with academic thought leaders to optimize clinical trial strategies.
  • Extensive interactions with other functional teams including HEOR, Medical Information, Scientific Communication, Commercial, Regulatory and others, to refine compound strategy and projects.
  • Coach and train internal colleagues as requested
  • Job Description

    Position Requirements

  • MD, PhD Pharm D, or equivalent required. If MD, Board Certified or board eligible in either Hematology or Oncology, or relevant Medical Specialty.
  • At least 3-10 years of experience in Hematology / Oncology clinical research in the pharmaceutical industry OR experience in clinical research or medical affairs is preferable or a combination of experience in academic medicine with clinical research and or clinical development experience in collaboration with the pharmaceutical industry.
  • Scientific medical research experience in Oncology and or Hematology (or relevant specialty) with demonstrated record of scientific medical publications.
  • Experience leading the design, conduct, analysis and reporting of clinical studies is strongly preferred.
  • Superior leadership, networking, collaboration and communication skills.
  • Successful interactions with Medical Experts and investigators.
  • Demonstrated the capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.
  • Ability to work across multiple functions is essential.
  • Effective oral and written communications skills and strong leadership are essential for success in the role.
  • Position will be filled at a level commensurate with experience.

    EEO Statement :

    The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

    Accessibility and reasonable accommodations

    The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

    Salary Range

    $204,400.00 - $379,600.00

    Skills Desired

    Agility, Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies {+ 4 more}

    Create a job alert for this search

    Medical Director Remote • East Hanover, NJ, United States

    Related jobs
    Behavioral Medical Director - Remote

    Behavioral Medical Director - Remote

    UnitedHealth Group • New York, NY, United States
    Remote
    Full-time
    Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives.The work you do with our team will directly improve health outcomes by connect...Show more
    Last updated: 30+ days ago • Promoted
    Sr Medical Director

    Sr Medical Director

    IPG Health • Littleton, NJ, United States
    Full-time
    Part of the IPG Health Network, FCBCURE is a full-service health and wellness agency with world-class creative talent and problem solvers focused on delivering robust HCP-, DTP-and DTC-engaging bra...Show more
    Last updated: 5 days ago • Promoted
    Regional Medical Lead-Remote

    Regional Medical Lead-Remote

    Novartis Group Companies • East Hanover, NJ, United States
    Remote
    Full-time
    Location : Remote (Field non-Sales) : This position can be based remotely in US.Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domest...Show more
    Last updated: 18 days ago • Promoted
    Medical Director - Infectious Disease

    Medical Director - Infectious Disease

    Quest Diagnostics • Secaucus, NJ, United States
    Full-time
    Medical Director - Infectious Disease.Medical Director of Infectious Disease to lead clinical strategies and innovation across our infectious disease testing portfolio. In this role, you'll bring de...Show more
    Last updated: 30+ days ago • Promoted
    Optum East Associate Medical Director, Network Partnerships - Field-based with Travel - Hybrid [...]

    Optum East Associate Medical Director, Network Partnerships - Field-based with Travel - Hybrid [...]

    UnitedHealth Group • Secaucus, NJ, United States
    Full-time
    Optum East (formerly Optum Tri-State NY) is seeking an Associate Medical Director, Network Partnerships to join our team in NY / NJ. Optum is a clinician‑led care organization that is changing the way...Show more
    Last updated: 30+ days ago • Promoted
    Director, WW Medical Cardiovascular & Immunology, Portfolio Strategy & Business Development

    Director, WW Medical Cardiovascular & Immunology, Portfolio Strategy & Business Development

    Bristol Myers Squibb • Princeton, NJ, US
    Full-time
    Uniquely Interesting Work, Life-Changing Careers.Those arent words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work h...Show more
    Last updated: 1 day ago • Promoted
    Medical Director (NYCE)

    Medical Director (NYCE)

    EmblemHealth • New York, NY, United States
    Full-time
    Manage the daily clinical operation and administration of a Medical Management Department or function to support improved utilization results across the spectrum of medical specialties.Provide clin...Show more
    Last updated: 21 days ago • Promoted
    Director, Global Market Access and Pricing Strategy - Oncology

    Director, Global Market Access and Pricing Strategy - Oncology

    Sanofi • MORRISTOWN, NJ, US
    Full-time
    Director, Global Market Access and Pricing Strategy - Oncology .Cambridge, MA or Morristown, NJ.Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurol...Show more
    Last updated: 23 hours ago • Promoted
    Medical Director, Pathology, Trinitas Regional Medical Center

    Medical Director, Pathology, Trinitas Regional Medical Center

    Rutgers University • New Brunswick, NJ, United States
    Full-time
    The Department of Pathology and Laboratory Medicine at Rutgers Robert Wood Johnson Medical School invites applications for a faculty position at the Assistant Professor or Associate Professor level...Show more
    Last updated: 8 days ago • Promoted
    Medical Director, Breast Oncology

    Medical Director, Breast Oncology

    Pfizer • New York, NY, US
    Permanent
    This position is for a Medical Director within the CDK4 program.This individual contributor position will be responsible for supporting clinical trial(s). The successful candidate should ideally hav...Show more
    Last updated: 11 days ago • Promoted
    Global LCM Senior Medical Director

    Global LCM Senior Medical Director

    Sanofi • MORRISTOWN, NJ, US
    Full-time
    Global LCM Senior Medical Director.This role is part of Global Medical Affairs team for Neurology within Specialty Care Medical Affairs. Our Medical Affairs function serves as key strategic partners...Show more
    Last updated: 1 day ago • Promoted
    Global Senior Medical Director Dermatology Pipeline Medical Lead

    Global Senior Medical Director Dermatology Pipeline Medical Lead

    Pfizer • New York, NY, US
    Full-time
    Global Senior Medical Director Dermatology Pipeline Medical Lead.The Global Senior Medical Director Dermatology Pipeline Medical Lead will report to the VP, Dermatology Medical Lead.He / she will b...Show more
    Last updated: 2 days ago • Promoted
    Director of Medical Affairs Research (Remote)

    Director of Medical Affairs Research (Remote)

    Nestlé SA • Bridgewater Township, NJ, United States
    Remote
    Full-time
    Director of Medical Affairs Research (Remote).At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these ...Show more
    Last updated: 30+ days ago • Promoted
    Global Medical Director - Hemophilia

    Global Medical Director - Hemophilia

    Sanofi • MORRISTOWN, NJ, US
    Full-time
    Global Medical Director Hemophilia.Cambridge, MA / Morristown, NJ.The role reports to the Global Head of Hemophilia within the Global Medical Rare Disease Organization. Sanofi Rare Diseases has buil...Show more
    Last updated: 1 day ago • Promoted
    Senior / Executive Medical Director

    Senior / Executive Medical Director

    HUTCHMED • Florham Park, NJ, United States
    Full-time
    The (Senior / Executive) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats...Show more
    Last updated: 13 days ago • Promoted
    Medical Director

    Medical Director

    Tandym Group • New York, NY, United States
    Full-time
    A healthcare organization in New York City is currently seeking an experienced and dedicated physician to join their staff as their new Medical Director!. Setting : Federally Qualified Health Center ...Show more
    Last updated: 19 days ago • Promoted
    Director, Oncology Imaging - (Remote)

    Director, Oncology Imaging - (Remote)

    Eisai • Nutley, NJ, United States
    Full-time
    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 pharm...Show more
    Last updated: 21 days ago • Promoted
    Optum East Associate Medical Director, Network Partnerships - Field-based with Travel - Hybrid NY

    Optum East Associate Medical Director, Network Partnerships - Field-based with Travel - Hybrid NY

    Optum • Secaucus, NJ, United States
    Full-time
    Optum East (formerly Optum Tri-State NY) is seeking a Associate Medical Director, Network Partnerships to join our team in for NY / NJ. Optum is a clinician‑led care organization that is changing the ...Show more
    Last updated: 1 day ago • Promoted