Medical Director, Hematology Job at Proclinical (Boston)

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Medical Director, Oncology

During the last five years, Parexel has participated in more than 1,000 Oncology...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Medically qualified based on successful completion of training at an accredited medical school
US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care
Excellent interpersonal skills
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
A willingness to work in a matrix environment and to value the importance of teamwork
The ability to travel 10% domestically and/or internationally as needed

Job Responsibility

Provide medical monitoring for assigned projects
Function as medical representative on the project team
Provide medical consultation as required or requested to client/sponsor or to other Parexel service groups
Assume the role of Senior Technical Lead in selected circumstances
Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor
Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate
Review documents written by various Parexel divisions for safety issues
Review coding of adverse events and concomitant medications for accuracy and consistency
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents

Director of Medical Group - Cancer Clinical Programs

The UVMHN Medical Group Director is a key member of the UVMHN Medical Group lead...

Location

United States , Burlington

Salary:

67.24 - 100.86 USD / Hour

The University of Vermont Health Network

Expiration Date

Until further notice

Requirements

Bachelor’s degree in business administration, Healthcare Management, or related field required
Master's Degree in Business Administration or Health Care Administration or a related area preferred
Minimum of 5-7 years of progressively responsible experience in health care operational management
2+ years of management/leadership with relevant experience in an oncology setting is preferred

Job Responsibility

Ensuring high-value services and operational oversight of assigned UVMHN Medical Group practices/services
Standardizing operational processes and policies
Leading people with emphasis on UVMHN’s Values, patient access, and patient experience
Collaborating with other UVMHN Medical Group Directors and UVMHN hospital-based leaders to support clinical integration and achievement of OKRs
Responsibility for business operations of hematology oncology as part of Network Dept of Medicine
Local clinical operations management of UVMMC hematology oncology and UVMMC surgical oncology practices
Oversight of Clinical Genetics, Oncology Nurse Navigation, Thrombosis and Hemostasis, Multidisciplinary Clinics, The Cellular Therapy Program, and the Vermont Regional Hemophilia Treatment Center
Working closely with leaders in oncology infusion, oncology pharmacy operations, oncology inpatient services, APPs, quality, patient experience, regulatory, finance, revenue cycle, UVM Cancer Center Clinical Trials Office, and other cancer-relevant clinical services

Fulltime

Clinical Lab Scientist I

The Clinical Lab Scientist I performs a range of standard and/or technically dem...

Location

United States , Los Angeles

Salary:

88962.00 - 146151.00 USD / Year

Children's Hospital Los Angeles

Expiration Date

Until further notice

Requirements

Minimum 1 year of post-baccalaureate clinical training as a Clinical Lab Scientist in a clinical laboratory
Minimum 1 year of work experience as a CLS performing high complexity testing in hematology, chemistry, blood bank, and microbiology in a CLIA-certified clinical laboratory by the Center for Medicare & Medicaid Services (CMS)
For Clinical Lab Scientist with Limited California License: Minimum 1 year of post-baccalaureate clinical training, OR Minimum 1 year of work experience in the specialty area related to the license
Bachelor’s degree meeting California Department of Public Health (CDPH) Laboratory Field Services academic requirements
Active California Clinical Laboratory Scientist (CLS) Licenses Or acceptable Limited California Licenses in specialty areas: Clinical Chemist Scientist License, Clinical Cytogeneticist Scientist License, Clinical Genetic Molecular Biologist Scientist License, Clinical Hematologist Scientist License, Clinical Histocompatibility Scientist License, Clinical Immunohematologist Scientist License, Clinical Microbiologist Scientist License

Job Responsibility

Performs a range of standard and/or technically demanding procedures in one or more of the Clinical Laboratory disciplines exercising initiative and independent judgment
Communicates technical or general information to their manager, director, & medical staff
Participate in administrative activities
Provides expertise and serves as a technical resource for others
May provide functional supervision to support staff

What we offer

Competitive compensation package
Robust benefits program

Fulltime

Global Study Director - Hematology/Oncology - Cell Therapy

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
Proven project management experience and training
At least 7 years of clinical trial experience
At least 3 years of experience in global study leadership and team leadership
Demonstrated clinical trial expertise in Hematology - Oncology
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery
startup, maintenance and close out
Thorough understanding of the cross-functional clinical trial process eg. Data flow
Strong strategic and critical thinking abilities
Proven skillset and abilities in complex problem solving and decision-making

Job Responsibility

Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection
Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required
Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended)
Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Medical Laboratory Scientist II

Baptist Health is looking to add a highly motivated and skilled Medical Laborato...

Location

United States , Jacksonville

Salary:

Not provided

Baptist Health (Florida)

Expiration Date

Until further notice

Requirements

Licensed as a Medical Technologist in the State of Florida
Licensed in the areas of Chemistry and Hematology
Trained in chemistry, coagulation, urinalysis, hematology and some serology
Strong critical-thinking and laboratory background
Associate's Degree
Less than 1 year Medical Technologist Experience
Licensed Clinical Laboratory Technician Required

Job Responsibility

Maintaining expertise and performing technical, specimen collection/processing, LIS, general department, and clerical functions in laboratory areas where applicable
Maintaining records of performance as defined in the SOP manuals
Supervision by Director and Section Supervisors
can perform all responsibilities without on-site supervision
Supervising MLTs as General Supervisor and serving as Charge Technologist in the absence of other lab supervisors or MTs
May instruct new employees and students
Rounding to other Baptist Health laboratory locations to perform safety and quality assurance audits

What we offer

$500 Sign-On Bonus
Mileage reimbursement provided
No weekends or holidays

Parttime

Medical Technologist Specialist - Automated Chemistry

The Medical Technologist Specialist is the technical expert in their assigned se...

Location

United States , Macon

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Registration as a Medical Laboratory Scientist (MT, MLS, CLT, CLS) by the Board of Registry as ASCP, AMT, AAB (AAB with 15yrs.experience), NCA, HHS certification or equivalent
Must be a High School or GED Diploma Graduate
Baccalaureate degree from accredited college or university to include minimum of 30 quarter hours of lecture science, including at least 15 quarter hours of chemistry, 10 quarter hours of biology, 5 quarter hours of math
At least 5 years general laboratory experience including one year of experience in the applicable area of responsibility: Hematology, Chemistry, Special Chemistry, or Blood Bank
Works in a fast-paced clinical environment
Works in an area which contains biohazardous (infectious) materials along with chemical, fire, and mechanical hazards
Duties may involve standing, walking, stretching, stooping, bending, and lifting light (20 pounds) to moderate heavy (50 pounds) loads
Must be able to use visual acuity to see monitor screen, computer, and hard copy materials
Must be able to hear and verbally communicate in person and over the phone or radio
Must be able to sit for prolonged periods of time (up to 2 hours)

Job Responsibility

Oversees the daily activities of section staff to ensure timely, accurate reporting of laboratory testing to assist physicians in providing patient care
Orients and mentors new staff members
Participates in the education and training of Med Tech students, MLT students, medical students, nursing students/staff and new laboratory section employees as needed
Collaboratively develops and implements technical orientation programs for new staff members
Ensures all standard operating procedures and practices adhere to Federal, State, and regulatory agency standards (CLIA, CAP, GDCH, TJC, OSHA, etc.)
Ensures competency of all staff by complying with regulatory requirements
Performs routine technologist duties and responsibilities during the shift to ensure validity of reported results and performance in accordance with department guidelines
Monitors department quality control to maintain effective operation of instrumentation and quality of reported results and to meet accreditation standards
Documents corrective and preventative actions taken
Evaluates abnormal and routine test results and resolves instrumentation problems to ensure validity of reported results in accordance with departmental and regulatory guidelines

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Director Biostatistics

Join Hemab, a clinical-stage biotech company, on an exciting journey to build th...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

PhD in Statistics/Biostatistics with 8+ years for Director pharmaceutical/biotech industry experience
Master's degree in Statistics/Biostatistics with 12+ years pharmaceutical/biotech industry experience
Extensive clinical development experience from early to late stage is required
NDA/BLA submission experience strongly preferred
Demonstrated ability to influence clinical development strategy and executive decision-making
Excellent communication skills with ability to present complex statistical concepts to non-statistical audiences
Experience with adaptive trial designs, Bayesian methods, and simulation techniques
Strong project management skills handling multiple concurrent programs
Direct experience with rare disease or hematology clinical trials highly desirable

Job Responsibility

Lead statistical input for clinical development plans, protocol design, endpoint selection, data analysis and interpretation
Develop innovative trial designs including but not limited to adaptive, and Bayesian approaches to maximize learning from limited patient populations
Author and review Statistical Analysis Plans (SAPs) and statistical sections of regulatory documents, and perform statistical analyses to inform decision making
Develop quantitative decision frameworks for dose-finding and proof-of-concept studies
Provide strategic statistical guidance for go/no-go decisions and portfolio prioritization
Prepare statistical components for regulatory submissions (INDs, NDAs/BLAs, CSRs)
Oversee CRO statistical deliverables and vendor relationships
Lead cross-functional collaboration with Clinical Research, Clinical Pharmacology, Clinical Operations, Data Management, Regulatory Affairs, and Medical Affairs
Foster innovation in statistical methodology and process improvement
Mentor/manage junior statistician(s)

Fulltime

Medical Director, Hematology

Proclinical

Location:
United States , Boston

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 14, 2026

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