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Senior Clinical Scientist (Associate Director), Early Clinical Development - Hematology/Oncology & Cell Therapy (immunology/neuroscience)
Taleo BE Brisbane, CA
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$150k-187k (estimate)
Full Time 1 Week Ago
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Taleo BE is Hiring a Senior Clinical Scientist (Associate Director), Early Clinical Development - Hematology/Oncology & Cell Therapy (immunology/neuroscience) Near Brisbane, CA

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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.com/working-with-us.

The Early Clinical Development (ECD-HOCT) team at BMS is responsible for hematology, oncology and cell therapy pipeline assets and sits at the interface between discovery and translational science and clinical drug development. Composed of physician-scientists and clinical-scientists, this group oversees the early development of both internal and partnered assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. Therapeutic areas span the full range of hematologic and solid tumor indications as well as select autoimmune disorder in the cell therapy portfolio. 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, dosing and combination strategies to enable faster and more effective drug development informed by core scientific principals 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. 

The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

Position Summary/Objective:

  • Responsible for implementation, planning, and execution of assigned clinical trial activities.

  • Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.

  • Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership).

  • May support clinical development planning in collaboration with Early Clinical Development physician(s).

Position Responsibilities:

  • Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.

  • Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable.

  • Evaluate innovative trial designs in collaboration with the study physician.

  • Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required.

  • Serve as primary contact for site-facing activities such as training and support for clinical questions.

  • Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.

  • Identify clinical data trends; provide trends and escalate questions to study physician.

  • Develop clinical narrative plan and review clinical narratives.

  • Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

  • Review/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review) activities.

  • Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).

  • Collaborate and serve as primary liaison between external partners for scientific advice.

  • Author/review abstracts, presentations, and manuscripts for external publications

Degree Requirements:

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).

Experience Requirements:

  • 5 years of experience in clinical science, clinical research, or equivalent

  • Must have prior experience working on immunology and/or neuroscience (e.g. Multiple Sclerosis) clinical studies; prior cell therapy experience is a plus

  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.

  • Proficient knowledge and skills to support program specific data review, trend identification, data interpretation

  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

Key Competency Requirements:

  • Excellent verbal, written, communication and interpersonal skills.

  • Must be able to effectively communicate and collaborate across functions and job levels.

  • Ability to assimilate technical information quickly.

  • Routinely takes initiative.

  • Detail-oriented.

  • Strong sense of teamwork; ability to lead matrix team activities.

  • Proficient in Medical Terminology and medical writing skills.

  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).

  • Proficient critical thinking, problem solving, decision making skills.

  • Understanding of functional and cross-functional relationships.

  • Commitment to Quality.

  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.

  • Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals).

  • Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools.

  • Domestic and international travel may be required (approximately 10-20%)

The starting compensation for this job is a range from $141,000 to $200,000 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 our BMS Career Site.

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 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 Year’s 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/infertilitybenefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

#LI-Hybrid

If you come across a role that intrigues you but doesn’t 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job Summary

JOB TYPE

Full Time

SALARY

$150k-187k (estimate)

POST DATE

05/05/2024

EXPIRATION DATE

05/20/2024

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