Director, Oncology Medical Affairs (USMA)

ACIST Medical Systems, Inc.; Needham (MA); Hybrid; USD 200,000 - 240,000; Full time

Benefits offered by this job

Healthcare plan

401k with matching

Paid holidays

Work-life harmony

Job summary

Blue Earth Diagnostics, a Bracco Imaging subsidiary, seeks a Director of USMA - Oncology to lead medical affairs strategy and oversee IIT initiatives. You will engage national and international KOLs, guide cross-functional teams, and ensure rigorous scientific oversight of clinical trials and medical information.

The role reports to the VP USMA – Oncology, requires five years in medical affairs/R&D, and frequent collaboration with regulatory, R&D, and commercial groups.

Qualifications

• Minimum of five (5) years relevant work experience, of which at least three (3) years are within Medical Affairs and/or Research & Development departments, preferably working in diagnostic nuclear medicine.
• Product launch experience preferred.
• Understanding of the clinical trials and FDA approval processes.
• Knowledge and understanding of US regulatory rules landscape (pertinent FDA Guidance for Industry), as well as Office of Inspector General and Dept. of Justice statutes and regulations; overall appreciation of the compliance landscape.
• Strong business and product marketing acumen, vision and perspective.
• Ability to comprehend and combine complex sets of data, spanning multiple projects and products.
• Ability to handle multiple demands in a fast-paced environment and to interact within the context of multidisciplinary teams.
• Excellent written and oral communication; superior presentation skills; strong analytical ability.
• Ability to interact and communicate with the highest degree of professionalism and scientific credibility with external scientific leaders (academic, government, consortia, laboratory chiefs in major institutions, etc.).
• A high level of initiative and independence.
• Travel will be required, estimated at approx. 30%. Travel will include major national conferences, advisory boards, interaction with scientific leaders and organizations (e.g. professional societies, patient advocacy), as well as annual national company meetings and departmental training sessions and retreats.
• Qualified candidate must be legally authorized to be employed in the United States.
• Excellent oral & written communication skills. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.

Responsibilities

• Provide medical oversight, and assist and support management, of the BED IIT program
• Provide USMA representation and support across multiple company sponsored clinical trials / global development programs, including assisting and advising on investigator and site selection, liaising with KOLs/investigators, assisting with insight generation as required to support these initiatives.
• Participate in strategic planning in a multidisciplinary setting involving clinical development, R&D, regulatory affairs, and commercial functions.
• Serve as medical reviewer as part of the Promotional Review Committee (PRC) and Medical/Legal/Regulatory (MLR) review processes.
• Provide medical oversight of the Medical Information function and serve as the first medical escalation point for unsolicited requests for medical information, ensuring responses are scientifically accurate, balanced, compliant, and aligned with applicable regulations and company policies.
• Serve as a member of the USMA – Oncology leadership team, and drive USMA programs/initiatives as assigned by the VP of USMA - Oncology
• Collaborate in training sales representatives and USMA field personnel in the principles and practices of disease management for targeted clinical areas and on the attributes and clinical data regarding BED marketed products and products in development.
• Lead the planning, execution, and scientific oversight of advisory boards, ensuring the collection of high-quality external expert insights to inform medical strategy, evidence generation, and patient care initiatives.
• Establish and maintain relationships with national/international Key Opinion Leaders in US and within targeted therapy areas in conjunction with Medical Science Liaisons (MSLs) across the country
• Serve as primary contact between Medical Affairs and the commercial team to provide high level medical and scientific data/information to external clinicians/organizations as needed.
• Serve as an internal medical subject matter expert to USMA and the broader organization.
• Provide medical input into the development of field team tools and resources.
• Stay current in targeted therapy areas and with current and future competition (on market and in development).
• Proactively maintain communications with other BED Medical Affairs & Clinical Development staff within the global team as needed to advance related initiatives.
• Perform any other duties as requested by the VP USMA – Oncology and/or the senior leadership team, ensuring the smooth operation and growth of the business.
• Other duties as business requires.

Skills

Medical affairs leadership

Clinical development

Regulatory affairs

KOL engagement

Cross-functional collaboration

Medical information oversight

Strategic planning

Data analysis

Scientific communication

Project management

Education

Advanced scientific or clinical degree (MD, PharmD, PhD, PA, NP, MSc or equivalent)

Job description

Blue Earth Diagnostics, a Bracco Imaging subsidiary, seeks a Director of USMA - Oncology to lead medical affairs strategy and oversee IIT initiatives. You will engage national and international KOLs, guide cross-functional teams, and ensure rigorous scientific oversight of clinical trials and medical information.

The role reports to the VP USMA – Oncology, requires five years in medical affairs/R&D, and frequent collaboration with regulatory, R&D, and commercial groups.