Job Details

Associate Director of Clinical Science

Clinical Development

icon-location-marker Remote - United States - US
icon-location-marker Field - United States - US
Posted 9 days ago Full_time R1583795

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 Associate/Director of Clinical Science plays a supportive role in clinical development of RazyeBio radiopharmaceuticals for oncology indications. Working in collaboration with clinical development, the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting, and potentially support of NDA/MAA filings.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

·Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific study concept synopses and protocols.

·Participates in protocol review discussions concerning scientific and procedural aspects of study design.

·In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance and supervision.

·Contributes to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans.

·Reviews ongoing clinical data.

·Organizes and oversees Data Review Committee meetings, including preparation of slides and other review and meeting materials.

·With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators.

·Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.

·Assists in the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.

·Supports priorities within functional area.

·Anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions.

·May be asked to coordinate teams and provide direction.

·May lead two or more specific components of departmental strategic initiatives.

·Able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.

·Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.

·May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.

·20% of travel required

Education and Experience

·PharmD or PhD preferred

·6+ years of relevant scientific and/or drug development experience with a MS (8+ for director level).

·8+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field (10+ for director level).

·3-5 years experience (3 for associate director.; 5 for director) in clinical research or clinical pharmacology in a biotech/pharmaceutical company, contract research organization, or academic institution.

Skills and Qualifications

·Demonstrated ability to be a fast learner.

·Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

·Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire.

·Knowledge of FDA, EMA and ICH regulations and guidelines a must.

Ability to effectively collaborate cross-functionally, across all levels of the organization.

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

BMS has a diverse 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 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.