Director Medical Affairs Research Operations
Director Medical Affairs Research Operations
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 194000 - 266000
1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. 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 highachieving 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: careers.bms/workingwithus.
RayzeBio a Bristol Myers Squibb company is a dynamic biotechnology company headquartered in San Diego CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.
The Director Medical Affairs Research Operations plays an integral role in supporting the Medical Affairs team. This position provides operational and scientific support of investigatorinitiated trials to ensure their successful implementation. This individual is responsible for activities associated with activation tracking and reporting of studyrelated information. This role will work crossfunctionally with several departments (Clinical Operations CMC Regulatory Affairs Supply Chain Drug Safety/PV Compliance and Legal).
Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
Provide operational expertise and lead the Investigator Initiated Trial (IIT) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements
Conduct budget negotiations for Medical Affairs IITs including fair market value assessments for all study related items. Create process for internal review of budgeting of trials
Maintain all internal records and databases associated with IIT program and develop reports when required
Create departmental SOPs and maintain these documents over time. Conduct training for crossfunctional partners on appropriate processes
Ensure that processes allow for activation of studies in a timely fashion consistent with the developed SOPs. Assist in activation workflow to ensure all study timelines are met
Create IIT strategy with cross functional team members both within medical affairs aswell as clinical development clinical operations regulatory legal etc
Collaborate with operations to ensure drug shipments milestones etc. are aligned to study specific timelines
Work with regulatory affairs to ensure that all investigatorinitiated trials adhere to relevant regulatory guidelines including IRB approvals and IND submissions
Maintain safety data from all trials to ensure patient safety and necessary documentation for any regulatory needs
Assess all IIT invoicing and perform budget reconciliation upon any changes within IIT protocols
Assist with other duties related to the operations of the IST program including facilitation and management of crossfunctional workstreams
Ability to travel (US and International) approximately 25 of time
Education and Experience:
Advanced degree (PhD Pharm D MD DO Advanced Nursing Degree Advanced Degree in Health Sciences MS or equivalent) with 5 yrs experience in leading an Investigator initiated trial (IIT) program in a pharmaceutical environment
Oncology experience required (GI oncology and radiopharmaceutical experience strongly preferred).
Demonstrated strong project management skills and leadership poise a must to negotiate and facilitate alignment amongst internal and external stakeholders (KOLs internal crossfunctional teams).
Skills and Qualifications:
Excellent and effective interpersonal and communication skills
Must be well organized and able to multitask in a fastpaced deadline driven environment
Prior experience interpreting and implementing regulations and guidelines governing clinical trials
Advanced computer and Internet skills including knowledge of MS applications (such as Word PowerPoint Teams Excel) Veeva electronic publication management tools SharePoint references databases PubMed etc.
Knowledge of information technology systems supporting medical affairs activities
Physical Demands:
While performing the duties of this job the employee is regularly required to sit reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
WorkEnvironment:
The noise level in theworkenvironment is usually moderate.
The starting compensation for this job is a range from $194000 $266000 plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job such as required skills and where the job is performed. Final individual compensation is decided based on demonstrated experience. For more on benefits please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.
Benefit 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 wellbeing resources and a 401(K). Financial protection benefits such as short and longterm disability life insurance supplemental health insurance business travel protection and survivor support. Worklife 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.
#RayzeBio
#LIOnsite
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.
Uniquely Interesting Work Lifechanging 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 careers.bms/eeoaccessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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:https://careers.bms/californiaresidents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Full-Time
