Talent.com
Director, Early Clinical Development (MD) – Hematology & Cell Therapy

Director, Early Clinical Development (MD) – Hematology & Cell Therapy

Bristol Myers SquibbMadison, Ohio, USA
3 hours ago
Job type
  • Full-time
Job description

Working with Us

Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more : Early Clinical Development (MD) Hematology & Cell Therapy with Focus in Cellular Therapy for Autoimmune Indications

The Director Early Clinical Development role will focus on the emerging and rapidly expanding area of cellular therapy for autoimmune indications. Physician-scientists and clinical-scientists within this group oversee the early development of both internal and partnered assets covering all cellular therapy platforms for autoimmune conditions. Therapeutic areas span the full range of autoimmune disorders including hematology rheumatology and neurology. The ECD-HOCT team interacts hand-in-glove with discovery and translational scientists project leadership late development and commercial colleagues to optimize biomarker patient enrichment and dosing strategies to enable faster and more effective drug development informed by core scientific principles and data.

Functional Area Description

The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development. Early Clinical Development drives clinical development strategy design execution and interpretation of clinical trials.

Position Summary / Objective

  • Serves as a primary source of medical accountability and oversight for multiple clinical trials
  • Manages Phase I / II studies with demonstrated decision making capabilities
  • Provides medical and scientific expertise to cross-functional BMS colleagues
  • Maintains matrix management responsibilities across internal and external networks

Position Responsibilities

Medical Monitoring

  • Independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept by
  • Articulating clinical development strategy

  • Analyzing interpreting and acting on Clinical Trial data to support development and
  • Serving as principal functional author for Regulatory submission study reports and publications
  • Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
  • Manages site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
  • Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
  • Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
  • Collaborates with CS and provides input into protocols contributing medical strategic oversight in protocol development (input on inclusion / exclusion and other safety-related clinical considerations)
  • Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
  • Acts as a focal point for defining and establishing relationships with key global Phase I Centers

  • Works on multiple trials across early development clinical lifecycle.
  • Clinical Development Expertise & Strategy

  • Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; Clinical studies include first-in-human Phase I proof of concept Phase I / II entry registrational studies and / or clinical pharmacology studies
  • Liaises with Clinical Scientists Translational & Discovery Scientists and Development Teams to define dose and schedule indications and patient selection (e.g. biomarker qualification and implementation)
  • Leads the analysis of benefit / risk for clinical development protocols in a matrix team environment working with Clinical Scientists
  • Partners with CS to support executional delivery of studies (e.g. site activation enrollment status as well as adjudication for protocol violations significant non-significant deviations etc.)
  • Maintains a strong medical / scientific reputation within the disease area; has in-depth knowledge of etiology natural history diagnosis and treatment of the disorder
  • Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature
  • Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
  • Provides ongoing medical education in partnership with CS to allow for protocol-specific training supporting the study team investigators and others
  • Ad-Hoc involvement in various departmental initiatives (e.g. committees sub-teams etc.)
  • Presents and / or articulates clinical strategy to senior leadership and to support progression of portfolio
  • Health Authority Interactions

  • Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
  • Authors / drafts clinical content for CSRs regulatory reports briefing books and submission documents to support closure clinical narratives reporting and filling of the study in partnership with Clinical Scientists
  • External Partnerships Alliances and Publications

  • Sits on team responsible for establishing key alliances with academic centers co-operative groups vendors and government agencies
  • Represents department in business development due diligence and partner alliance management with oversight
  • Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
  • Track record or recognized for contributions to field (e.g. publications patents keynote participation in conferences etc.)
  • Degree Requirements

  • Advanced degree(s) in relevant field : MD MD / PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g. attending level or international equivalent)
  • Subspecialty fellowship training in rheumatology or hematology area preferred
  • Experience Requirements

  • 5 years of relevant experience in discovery translational and / or clinical research in academic or industry setting including education where applicable
  • Clinical trial leadership experience (e.g. study director etc.) within pharmaceutical industry preferred OR
  • Significant independent clinical / laboratory / translational research experience in academic / pharmaceutical setting preferred including demonstrable achievement in experimental design interpretation and exposition
  • Key Competency Requirements

  • Ability to communicate and present information clearly in scientific and clinical settings
  • Expertise in the scientific method to test hypotheses including statistical design analysis and interpretation
  • Knowledge of drug development process
  • Knowledge of the components needed to execute an effective clinical plan and protocols
  • Strong leadership skills with proven ability to lead and work effectively in a team environment
  • If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

    Compensation Overview :

  • Brisbane - CA - US : $308700 - $374075 Cambridge Crossing : $308700 - $374075 Madison - Giralda - NJ - US : $275630 - $333998 Princeton - NJ - US : $275630 - $333998
  • The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility / infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    Uniquely Interesting Work Life-changing Careers

    With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

    If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information : data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

    Required Experience :

    Director

    Key Skills

    Business Development,Financial Services,Import,Air Pressure Handling,Clinical

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Create a job alert for this search

    Director Development • Madison, Ohio, USA

    Related jobs
    • Promoted
    Urology

    Urology

    KPG Provider ServicesAshtabula, Ohio, US
    Full-time
    Urology physician employment in Ohio : Inpatient Facility : Looking for an experienced Perm - Physician - Urology Ashtabula, OH in the Ashtabula, Ohio area. Below you will find the Position Overview ...Show moreLast updated: 30+ days ago
    • Promoted
    Intensive Home Based Treatment Therapist

    Intensive Home Based Treatment Therapist

    Applewood CentersMontville, OH, US
    Remote
    Full-time
    At Applewood, we prioritize our employees and their wellbeing.We provide competitive benefit options to our employees and their families, including domestic partners. Comprehensive health and Rx pla...Show moreLast updated: 17 days ago
    • Promoted
    Mental Health Therapist - Outpatient - Eating Disorders

    Mental Health Therapist - Outpatient - Eating Disorders

    LifeStance HealthBurton, OH, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 30+ days ago
    • Promoted
    Service Area Director

    Service Area Director

    CentennialBainbridge, OH, US
    Full-time
    Lighthouse Youth & Family Services.Lighthouse Youth & Family Services.Lighthouse Youth Center at Paint Creek.The intensive innovative treatment provided is trauma-informed and strength-base...Show moreLast updated: 1 day ago
    • Promoted
    Neurology

    Neurology

    KPG Provider ServicesAshtabula, Ohio, US
    Full-time
    Neurology physician employment in Ohio : Looking for an experienced Perm - Physician - Neurology Ashtabula, OH in the Ashtabula, Ohio area. Below you will find the Position Overview with all the det...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract Nurse Practitioner - Family Practice

    Local Contract Nurse Practitioner - Family Practice

    American Medical StaffingLeavittsburg, OH, US
    Full-time
    American Medical Staffing is seeking a Nurse Practitioner Family Practice for a local contract job in Leavittsburg, Ohio. Job Description & Requirements.We’re living in the new normal.Live...Show moreLast updated: 30+ days ago
    • Promoted
    LPN Primary Care Madison

    LPN Primary Care Madison

    University HospitalsMadison Township, OH, US
    Full-time
    Provides safe efficient age specific nursing care to patients / families using the nursing process in order to assist them to attain, maintain, regain, and sustain optimal health status.Functions in ...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract Nurse Practitioner - Family Practice - $66 per hour

    Local Contract Nurse Practitioner - Family Practice - $66 per hour

    American Medical StaffingLeavittsburg, OH, US
    Full-time
    American Medical Staffing is seeking a Nurse Practitioner Family Practice for a local contract job in Leavittsburg, Ohio. Job Description & Requirements.We’re living in the new normal.Lives and care...Show moreLast updated: 1 day ago
    • Promoted
    Travel Nurse RN - Med Surg

    Travel Nurse RN - Med Surg

    PRN HealthcareWarren, OH, US
    Full-time
    PRN Healthcare is seeking a travel nurse RN Med Surg for a travel nursing job in Warren, Ohio.Job Description & Requirements. PRN Healthcare Job ID #1470032.Pay package is based on 12 hour shift...Show moreLast updated: 17 days ago
    • Promoted
    Remote Finance Director - AI Trainer ($50-$60 / hour)

    Remote Finance Director - AI Trainer ($50-$60 / hour)

    Data AnnotationWarren, Ohio
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...Show moreLast updated: 30+ days ago
    • Promoted
    Lab Manager

    Lab Manager

    HowmetNiles, OH, United States
    Full-time
    Warren Avenue, Niles, OH, 44446, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to l...Show moreLast updated: 6 days ago
    • Promoted
    Shift Manager

    Shift Manager

    Arby'sAshtabula, OH, US
    Full-time
    We’re glad you’re here.You may know us as the brand with Roast Beef and Curly Fries – but we are also crafting incredible career opportunities. You’re in the right place if y...Show moreLast updated: 30+ days ago
    • Promoted
    Physician - Hematology / Oncology + Retention Bonus + Visa Accepted

    Physician - Hematology / Oncology + Retention Bonus + Visa Accepted

    KA Recruiting Inc.Ashtabula, OH, US
    Permanent
    Full-Time, Permanent | Days (negotiable) + On-Call (10 days / month, including weekends).Join a respected healthcare system affiliated with the Cleveland Clinic, providing comprehensive cancer care t...Show moreLast updated: 30+ days ago
    • Promoted
    Mental Health Therapist - Outpatient - PTSD EMDR

    Mental Health Therapist - Outpatient - PTSD EMDR

    LifeStance HealthBurton, OH, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 30+ days ago
    • Promoted
    Couples Therapist - LISW LPCC IMFT - Outpatient

    Couples Therapist - LISW LPCC IMFT - Outpatient

    LifeStance HealthBurton, OH, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 30+ days ago
    • Promoted
    LPN Rainbow Pediatrics- Madison

    LPN Rainbow Pediatrics- Madison

    University HospitalsMadison Township, OH, US
    Full-time
    Provides safe efficient age specific nursing care to patients / families using the nursing process in order to assist them to attain, maintain, regain, and sustain optimal health status.Functions in ...Show moreLast updated: 2 days ago
    • Promoted
    RN - Surgical ICU Stepdown in Warren, Ohio - $2,046 / week

    RN - Surgical ICU Stepdown in Warren, Ohio - $2,046 / week

    VettedWarren, OH, US
    Full-time
    Vetted is seeking a RN - Surgical ICU Stepdown for a travel job in Warren, Ohio.The job was posted 21 days ago.The assignment starts on ASAP and is 13 weeks long with 8 hour shifts 5 days a week.Yo...Show moreLast updated: 13 days ago
    • Promoted
    Gastroenterology

    Gastroenterology

    KPG Provider ServicesAshtabula, Ohio, US
    Full-time
    Gastroenterology physician employment in Ohio : TBD .ElementsByTagName("script")[0]; first.Before(script, first);}; reb2b. Board Certified or Board Eligible Medical Doctor with or w / o US res...Show moreLast updated: 30+ days ago