Clinical Trial Lead

Employer: Bristol Myers Squibb Company
Location: Princeton, NJ, US
Start date: Dec 12, 2018

Discipline: Clinical, Clinical Trials
Required Education: Doctorate/PHD/MD
Position Type: Full time
Hotbed: Pharm Country, Best Places to Work

Job Details
Company

Job Details

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

** The Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **

JOB DESCRIPTION

Work with the Program Lead and team members to translate the FDT strategy into trial options and protocols
Clinical monitoring of one or more studies
Medical Data Review (and data cleaning support as appropriate) of ongoing studies working with Clinical Operations and Data Management.
Addresses relevant clinical queries from study sites with documentation in eTMF
Identify and builds relationships with investigators
Contributes to DSURs and PSURs
Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
Work consistently in a matrix environment
MD, PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge
The position is based in the Princeton, NJ area

JOB REQUIREMENTS

Responsible for the study timelines in a cross-functional matrix protocol team
Responsible for the clinical development activities from site(s) initiation to study discontinuation
Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements
In collaboration with GRS and GPV&E, designs and implements safety monitoring plans
Interprets clinical data and makes appropriate decisions and recommendations
Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions
Work with the Program Lead, team members and governance bodies to translate the FDT strategy into trial options, protocols and action plans
Work with the Program leads to author clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview
Addresses relevant clinical queries from study sites; and authors responses to study related HA and IRB questions

ESSENTIAL LEADERSHIP BEHAVIORS

Identify and builds relationships with study investigators
Is seen and acts as the study expert by the site personnel
Ability to work and communicate efficiently with internal partners in the US for positions located outside the US
Identify and builds relationships with principal investigators
Identify Thought Leaders and use them for inputs in clinical strategy and protocol design
Maintain a strong medical/scientific reputation within the disease area
Contribute to Health Authority interactions as a Medical Monitor on assigned clinical studies
Share specific clinical strategies with other clinical teams
Study-specific clinical design and execution
Manage communication with key stakeholders (senior)

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry - e.g. monitoring)
Management of one or more uncomplicated studies and preparation of regulatory documents
New entrance to pharma: out of fellowship/ new to industry
Limited clinical research experience (substantial academic research experience could potentially substitute)

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

Relevant clinical research experience (relevant academic research experience could potentially substitute)
Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
Has a history of handling multiple, complex, studies in parallel
Has a history of prior meaningful participation in regulatory submissions
Has a history of strong interaction with thought leaders
Proven team leadership capability
Performs as an individual contributor
Identifies when an issue is present and begins to address

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

Company info

Website: http://www.bms.com/
Phone: +1-800-332-2056
Location: 430 E. 29th St
14th Floor
New York
New York
10016
United States

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