Head of Medical Affairs NA Job Details | curium

Maryland Heights, Missouri


Employer: curium
Industry: Regulatory Affairs
Salary: Competitive
Job type: Full-Time

About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Head of Medical Affairs NA will lead the planning, execution, and completion of medical affairs projects/programs for Curium radiopharmaceuticals. This includes pre-launch, launch, and post-launch activities for radio-therapeutic and radio-diagnostic imaging products. The role involves reviewing unsolicited Investigator Initiated Studies (IIS) proposals, interpreting data, and supporting the lifecycle management of Curium's products.

The Head of Medical Affairs NA will collaborate with Clinical Development and RWE/HEOR functions and ensure medical training programs are designed and delivered. The role also involves building relationships with key stakeholders, providing medical guidance, and maintaining high ethical and scientific standards, ensuring all activities align with corporate objectives.

Essential Functions

  • Develop and execute medical affairs strategy for existing and new radio-pharmaceutical products in the US/NA, aligned with corporate strategy.
  • Drive key medical affairs deliverables throughout the product lifecycle including pre-launch, launch, and post-launch phases.
  • Define accurate medical claims based on clinical trial data and RWE/HEOR studies.
  • Review unsolicited IIS proposals and contribute to decision-making within the IIS Scientific Review Board.
  • Maintain scientific relationships with key opinion leaders (KOLs) and cover national and international conferences.
  • Provide clinical, medical, and scientific presentations to various internal and external groups.
  • Organize and support Medical Scientific Advisory Board meetings and content development.
  • Collaborate with medical affairs field-based employees and rapidly respond to medical/scientific questions.
  • Participate in scientific meetings and design medical training curriculum for US/NA and field MSLs.
  • Evaluate and refine medical training plans and maintain expertise in relevant oncology disease areas.
  • Define and manage budget and timelines for medical affairs activities.
  • Develop medical communication and publication plans in collaboration with the Medical Communication/Publication function.
  • Ensure all US/NA medical affairs activities follow QA and Compliance principles.
  • Provide strategic medical practice input for product lifecycle management and develop collaborations with external stakeholders.
  • Function as a central point of contact for the medical community regarding Curium's products.


Requirements

  • Medical Doctor (MD) preferred, or PharmD/PhD in life sciences with experience in Oncology and significant Medical Affairs experience.
  • 20 years of relevant pharmaceutical industry experience with at least 5 years in Medical Affairs, specifically in Oncology.
  • Experience in clinical, medical, and scientific relationship management.
  • Strong strategic problem-solving and risk mitigation skills.
  • Knowledge of legal, regulatory compliance, and medical promotional regulations.
  • Proven track record in medical affairs project management in the US/NA.
  • Ability to evaluate clinical trial results and medical messaging.
  • Excellent communication, presentation, and training skills.
  • Experience interacting with regulatory authorities and oncology societies.
  • Strong leadership and interpersonal skills with the ability to influence in a matrix environment.
  • Commitment to continuing education and adaptability in a fast-paced environment.
  • Fluency (written and spoken) in English is mandatory.
  • Willingness to travel 25-35% occasionally with short notice.


Working Conditions:
  • This position will work in typical office conditions with extensive time using personal computer equipment.
  • May be required to sit or stand for long periods of time while performing duties.
  • Close attention to detail required.
  • Willingness to work in a team-based environment.
  • The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.
  • Ability to travel domestically and potentially Internationally as required.


Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Segment: Oncology, Compliance, Pharmaceutical, PLM, Medical Technologist, Healthcare, Legal, Management, Science

Created: 2024-08-22
Reference: S1Lp8poNJ6RD
Country: United States
State: Missouri
City: Maryland Heights


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