Associate Director, Worldwide Medical, Established - Township of Lawrence, United States - Bristol-Myers Squibb

Bristol-Myers Squibb
Bristol-Myers Squibb
Verified Company
Township of Lawrence, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description

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.


Position Summary


The Established Brands Associate Director is responsible for strategy and execution of medical affairs-related activities for brands in the Established Brands portfolio, with focus on the Hematology and Oncology therapeutic area.


Key Responsibilities

  • Working closely with the Team Lead and the Worldwide Established Brands team, provide medical oversight and manage WW medical activities for the Hematology and Oncology brands within the expanding Established Brands Organization.
  • Lead global medical activities in support of strategic execution of plans in regions where brand continues to be actively commercialized and develop and execute medical strategy for expansion into new markets.
  • Provide medical assessments of risk/benefit of assigned products regarding new indications, safety or stability/quality issues, medical necessity/sensitivity assessments or other actions that require reappraisal of the product Risk/Benefit.
  • Work closely with key crossfunctional matrix partners: Commercial, Regulatory, Safety, Labeling, Supply & Manufacturing, Quality & Compliance to support brand activities (e.g., labeling, safety, quality, deletions).
  • Lead medical insight at crossfunctional teams, including revaluation of WW medical content, local market needs, and labeling recommendations based on proactive signal detection activities.
  • Provide medical input for regulatory requirements including response to Health Authorities queries, support for registration renewals and label periodic reviews.
  • Provide medical support and input to the CCDS content review and development.
  • Provide medical evaluation and appropriate communications to additional documents and activities such as: Dear Health Care Professional letters, Clinical Overview for Type II variation and coordinate expert reports.
  • Provide clinical trial expertise for new evidence generation needs or healthauthority commitment studies.
  • Compliance Support delivery of medical affairs compliance needs for the assigned portfolio, as appropriate.
  • Management, as appropriate, of the budget allocated to the specific projects.

Qualifications & Experience

  • MD, PharmD, PhD or Equivalent.
  • MD with Medical specialty in Hematology or Oncology strongly preferred.
  • 710 years of clinical and pharmaceutical industry experience.
  • Excellent oral and written communication skills.
  • Demonstrate flexibility, open mindedness, and adaptability in a rapidly changing environment.
  • Ability to promote collegiality and teamwork, as well as to think clearly and decisively when presenting independent, reasoned solutions to identified safety issues
  • Experience Desired
  • Knowledgeable and skilled in medicine and pharmaceutical product preferably related to both clinical trial and postmarketing safety.
  • Familiarity with regulatory guidelines.
  • Considerable Multi-Brand Medical Affairs and Pharmacovigilance-Safety experience would be an advantage.

#LI-Hybrid

Uniquely Interesting Work, Life-changing Careers

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 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.
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