Senior Director, Clinical Pharmacology
Senior Director, Clinical Pharmacology
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$ 241000 - 293000
1 Vacancy
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: 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 drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.
The Senior Director Clinical Pharmacology will be a key member of the development team developing clinical pharmacology strategy leading the design execution interpretation and reporting of clinical pharmacology data and serve as clinical pharmacology lead on studies and project teams. The role will support projects at various stages of development playing an active role in our drug discovery and development efforts to advance RayzeBios radiopharmaceutical pipeline. This role can be based onsite in either San Diego CA or Lawrenceville NJ.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
Develop clinical pharmacology strategy and related clinical development plan consistent with the development strategy program goals and the US/international regulatory guidance for radiopharmaceuticals.
Collaborate with DMPK clinical development and CMC teams to define clinical pharmacology data needed to support NDA and drug label.
Determine scope design plan analyze and interpret pharmacokinetic and pharmacodynamics (PK/PD) in company-sponsored studies including development of appropriate population PK models and PK/PD analysis required from a development and regulatory perspective to take a project from concept stage to commercialization.
Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations Clinical Development Biometrics and Regulatory Affairs.
Contribute to the design and execution of Phase 1 clinical pharmacology (eg drug-drug interactions relative bioavailability/bioequivalence special populations and thorough QT etc.) and dosimetry studies.
Contribute to writing of protocols investigator brochures clinical study reports and review of other clinical trial documents.
Plan prepare and review clinical pharmacology section of the regulatory documents (IND IMPD IB NDA CTD etc.) participate in drafting publications and making scientific presentations consistent with development strategies.
Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to ensure integration of clinical pharmacology principles into project plans and study design.
Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities.
Other duties as assigned.
Willing to travel up to approximately 10% of the time (if not based in San Diego area).
Education and Experience:
PhD MD or PharmD with at least 8-10 years of pharmaceutical or biotech experience in clinical pharmacology and oncology drug development.
Experience with early and late-stage clinical development IND and filing dossier
Radiopharmaceutical experience is preferred but not required.
Skills and Qualifications:
Patient-focused with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics
Motivated to work in a fast-paced high accountability small company environment. A can do and collegial professional who leads through influence and interpersonal skills.
Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
Demonstrated ability to collaborate successfully with multiple functions in a team environment.
Intellectually curious with courage to challenge and seek new ways to improve work.
Strong written and oral communication skills including presentation skills.
Ability to analyze and interpret data and develop written reports and presentations of those data.
Strong critical strategic and analytical thinking skills.
Strong background and expertise in Clinical Pharmacology PK and PK/PD demonstrated by major Regulatory submission experience and/or scientific publications.
Proven ability to manage strategic scientific and operational aspects of development projects from a Clinical Pharmacology perspective.
Skilled in clinical research and understand the process of pharmaceutical product development and approval.
Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOPs).
Solid understanding of GCP and ICH guidelines.
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 jobis a range in San Diego CA is from $261000 to 316000 and in Lawrenceville NJ is from $241000 to 293000 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job such as required skills and where the job is performed. 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 subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical pharmacy dental and vision care. Wellbeing supportsuch asthe 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 -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 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.
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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 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:
Exec
Employment Type
Full-Time
