Logo of Huzzle

Home

Matches

Explore

Manage

Director, Medical Affairs Research Operations

image

Bristol Myers Squibb

12d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • San Diego

AI generated summary

  • You need an advanced degree, 5+ years in IITs, oncology experience, strong project management, excellent communication skills, regulatory knowledge, and advanced IT skills. Travel 25% required.
  • You will lead IIT operations, manage budgets and compliance, maintain records, develop SOPs, ensure timely study activations, and collaborate across functions, while traveling 25%.

Requirements

  • Advanced degree (PhD, Pharm D, MD, DO, Advanced Nursing Degree, Advanced Degree in Health Sciences, MS, or equivalent) with 5+ yrs experience in leading an Investigator initiated trial (IIT) program in a pharmaceutical environment
  • Oncology experience required (GI oncology and radiopharmaceutical experience strongly preferred).
  • Demonstrated strong project management skills and leadership poise a must to negotiate and facilitate alignment amongst internal and external stakeholders (KOLs, internal cross-functional teams).
  • Excellent and effective interpersonal and communication skills
  • Must be well organized and able to multi-task in a fast-paced deadline driven environment
  • Prior experience interpreting and implementing regulations and guidelines governing clinical trials
  • Advanced computer and Internet skills, including knowledge of MS applications (such as Word, PowerPoint, Teams, Excel), Veeva, electronic publication management tools, SharePoint, references databases, PubMed, etc.
  • Knowledge of information technology systems supporting medical affairs activities
  • Ability to travel (US and International) approximately 25% of time

Responsibilities

  • Provide operational expertise and lead the Investigator Initiated Trial (IIT) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements
  • Conduct budget negotiations for Medical Affairs IITs, including fair market value assessments for all study related items. Create process for internal review of budgeting of trials
  • Maintain all internal records and databases associated with IIT program and develop reports when required
  • Create departmental SOPs and maintain these documents over time. Conduct training for cross-functional partners on appropriate processes
  • Ensure that processes allow for activation of studies in a timely fashion consistent with the developed SOPs. Assist in activation workflow to ensure all study timelines are met
  • Create IIT strategy with cross functional team members both within medical affairs as well as clinical development, clinical operations, regulatory, legal, etc
  • Collaborate with operations to ensure drug shipments, milestones, etc. are aligned to study specific timelines
  • Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant regulatory guidelines, including IRB approvals and IND submissions
  • Maintain safety data from all trials to ensure patient safety and necessary documentation for any regulatory needs
  • Assess all IIT invoicing and perform budget reconciliation upon any changes within IIT protocols
  • Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams
  • Ability to travel (US and International) approximately 25% of time

FAQs

What is the primary role of the Director, Medical Affairs Research Operations?

The primary role includes providing operational and scientific support for investigator-initiated trials (IITs), ensuring successful implementation and compliance with regulatory requirements while working cross-functionally with various departments.

What qualifications are required for this position?

An advanced degree (PhD, Pharm D, MD, DO, or equivalent) along with 5+ years of experience leading an IIT program in a pharmaceutical environment is required. Oncology experience is mandatory, with a preference for GI oncology and radiopharmaceutical experience.

Is travel required for this position?

Yes, the position requires the ability to travel approximately 25% of the time, both in the US and internationally.

What types of benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a variety of competitive benefits including healthcare coverage, financial well-being resources, work-life programs, parental leave, tuition reimbursement, and more, tailored to support both personal and professional goals.

Are there opportunities for growth and development in this role?

Yes, Bristol Myers Squibb provides opportunities for professional growth and development through a range of resources and programs designed to help employees thrive in their careers.

What specific skills are important for this position?

Important skills include effective interpersonal and communication skills, strong organizational abilities, project management expertise, and experience with clinical trial regulations and guidelines.

What is the starting compensation range for this position?

The starting compensation for this job ranges from $194,000 to $266,000, plus incentive cash and stock opportunities, depending on skills and experience.

Are there any specific software or tools knowledge required for this job?

Yes, candidates should have advanced computer skills, including familiarity with MS applications (Word, PowerPoint, Teams, Excel), Veeva, electronic publication management tools, and PubMed.

Does this role require creating and maintaining SOPs?

Yes, the role involves creating departmental SOPs and maintaining those documents, including training cross-functional partners on the appropriate processes.

What is the work environment like for this position?

The work environment is usually moderate in noise level, with the requirement for sitting, reaching, and talking or hearing while occasionally lifting or moving up to 20 pounds.

image

Bristol Myers Squibb

Manufacturing & Electronics
Industry
10,001+
Employees

Mission & Purpose

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome. Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients. Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.