Job Details
Clinical Development
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, External Data Acquisition is a leadership role which contributes directly to the BMS R&D pipeline. Associate Directors may be People Managers or Individual Contributors.
This role reports into the Head of External Data Acquisition and is a full-time, office-based position with flexibility to work remotely up to 50% of the time.
Primary Responsibilities include:
All Associate Directors are responsible for the following but may focus on specific responsibilities as required by business need:
- Efficiently planning, coordinating, and delivering complete and high quality deliverables for assigned studies, programs, assets and associated stakeholder groups.
- Driving the data collection strategy for external vendor/partner generated clinical trial data, championing consistency across programs and therapeutic areas.
- Leading the planning, set-up, and acquisition of external clinical data from study start through initial transfer and managing amendments and post final changes. Ensuring ongoing data transfers are received as expected.
- Creating external data transfer specifications, ensuring external clinical trial data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting and ensuring timely data availability once specifications are approved.
- Holding accountability to resolve complex issues, leveraging technical/functional expertise to proactively develop solutions. Using clear communications and collaborative strategies to drive to resolution and remove barriers to execution.
- Leading initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.
- Authoring procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.
- Developing and maintaining templates and tools which support the function.
- Developing and conducting training and/or mentoring team members on key activities and processes.
- Managing trackers, metrics, and key performance indicators for the function to ensure timely delivery, appropriate visibility, and proactive identification/resolution of issues and trends.
- Representing the function for Health Authority inspections and internal audits. Ensuring preparations and follow-up actions are completed effectively.
- Leading CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause. Ensuring timely closure of CAPA actions.
- Ensuring effective quality oversight of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing activities on behalf of BMS to ensure high quality and timely delivery.
- Developing strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS to drive results and remove barriers to execution.
- Representing BMS in interactions with key external partners as part of any committee or industry group.
- In addition to the above responsibilities, the following apply to People Managers:
- Managing the book of work – assigning resources, ensuring high quality and timely delivery by team members.
- Leading the resolution of issues regarding the book of work - proposing solutions, aligning with impacted stakeholders, and driving to resolution.
- Forecasting future resource needs based on the book of work and initiatives; proposing solutions to meet potential resource constraints.
- Assigning resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion.
- Working proactively with staff to understand individual strengths, opportunities, and career goals; supporting development of plans that capitalize on strengths and address opportunities; providing regular feedback to promote development.
- Effectively coaching and mentoring staff, seeking out training opportunities where needed, to develop the next generation leaders.
- Developing and promoting a workplace culture that values diversity of thought, promotes integrity, creates accountability, supports effective decision making, and provides opportunities to grow.
Key competencies include:
- Deep understanding of the drug development process. Proven expertise in external clinical data acquisition and integration processes and technologies.
- Strong knowledge of industry leading tools and well versed in industry trends and emerging technologies supporting external clinical data acquisition.
- Strong knowledge of GCP/ICH guidelines.
- Significant experience with inspection readiness and CAPA development.
- Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion.
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Strong stakeholder management and project management skills.
- Excellent oral and written communication skills.
- Demonstrated partnership across various collaborative and industry forums.
- Diverse and deep technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory, quality etc.).
- Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team and to effectively collaborate with other stakeholders.
Degree and experience requirements:
Bachelors degree required with an advanced degree preferred. At least 7 years of global clinical trial expertise with a focus on external clinical data acquisition and integration. Successful track record of leading through influence, working across complex, global organizational matrices, and effectively managing staff (for People Managers).
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.
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.com/california-residents/
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