What are the responsibilities and job description for the Global Medical Affairs Asset Lead (GMAL) Rare Disease position at BioSpace?
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Medical Affairs Asset Lead (GMAL) Rare DiseaseWhat you will do
Lets do this. Lets change the world. In this vital role you will be co-leading the development and execution of Global product medical strategy, through the Global Medical/Strategic Plan (Global Brand Plan), including lifecycle management, in collaboration with the Product Team/Therapeutic Area Governance, & Portfolio Governance. You will lead the development of scientific evidence gaps, evidence generation strategy & plan in alignment with GBP and cross functional partners. You will support clinical trial conduct and participate in engagement of external key stakeholders in partnership with other functions.
Responsibilities
We are all different, yet we all use our unique contributions to serve patients. The Medical Asset Lead we seek is a medical strategy leader with these qualifications.
Basic Qualifications
Doctorate degree and 4 years of medical asset leadership experience
OR
Masters degree and 7 years of medical asset leadership experience
OR
Bachelors degree and 9 years of medical asset leadership experience
Preferred Qualifications
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Medical Affairs Asset Lead (GMAL) Rare DiseaseWhat you will do
Lets do this. Lets change the world. In this vital role you will be co-leading the development and execution of Global product medical strategy, through the Global Medical/Strategic Plan (Global Brand Plan), including lifecycle management, in collaboration with the Product Team/Therapeutic Area Governance, & Portfolio Governance. You will lead the development of scientific evidence gaps, evidence generation strategy & plan in alignment with GBP and cross functional partners. You will support clinical trial conduct and participate in engagement of external key stakeholders in partnership with other functions.
Responsibilities
- Provide medical leadership and strategic direction for Amgen's global portfolio in Rare Disease TA
- Collaborate with cross-functional teams to develop and execute global medical strategies and plans for products in this TA
- Serve as the subject matter expert in rare disease, keeping up-to-date with the latest research, scientific advancements, and market trends.
- Develop and maintain relationships with key opinion leaders, medical societies, and other external stakeholders to advance Amgen's scientific and medical objectives.
- Lead and participate in global advisory boards, medical education programs, and other medical activities to support the adoption and appropriate use of Amgen's products.
- Ensure compliance with all applicable regulations and guidelines related to medical affairs activities.
- Oversee the development and execution of medical communication plans, including publications, presentations, and congress activities.
- Provide medical input and support for product development, including clinical trial design and data interpretation.
- Collaborate with commercial teams to develop and implement medical strategies for product launches and life-cycle management.
- Mentor and develop team members, providing guidance and support for their professional growth and development.
- Represent Amgen at medical conferences and other scientific meetings, presenting data and engaging with key stakeholders.
- Play a key role in identifying and evaluating potential external collaborations and partnerships in chronic weight management space.
- Contribute to the development of global medical affairs processes and procedures to ensure compliance, efficiency, and continuous improvement.
- Serve as a key point of contact for medical inquiries from internal and external stakeholders.
- Stay abreast of competitive landscape and provide insights and recommendations to inform business decisions.
- Drive innovation and continuous improvement in the medical affairs function, staying current with industry best practices and trends.
- Collaborate with cross-functional teams to support the development and execution of patient-focused initiatives and programs.
- Represent Amgen's commitment to patients and healthcare
- Participate in development of data communication strategy (including congress)
- Support Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
- Support implementation of Medical governance for respective product, which includes: safety and pharmacovigilance as a key and effective partner with GRAAS, global risk management/minimization in collaboration with GRAAS
We are all different, yet we all use our unique contributions to serve patients. The Medical Asset Lead we seek is a medical strategy leader with these qualifications.
Basic Qualifications
Doctorate degree and 4 years of medical asset leadership experience
OR
Masters degree and 7 years of medical asset leadership experience
OR
Bachelors degree and 9 years of medical asset leadership experience
Preferred Qualifications
- MD plus accredited fellowship, board certified or board eligible
- Accredited fellowship in Rheumatology or Allergy and Immunology (Board certified or board eligible)or
- PharmD or PhD
- 6years of medical affairs or clinical development experienceincludinginrare disease space
- Broad and formal leadership experience:Min2-3 years of people management experience
- Excellent written, oral and presentation skills
- Demonstrated ability as a medical expert in rheumatological or rare diseases & ability to navigate in a complex matrix environment
- Pharmaceutical product development, productlifecycleand commercialization process knowledge with understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
- In-depthexperience with opinion leader interactions and management
- Pharmaceutical product development, productlifecycleand commercialization process knowledge with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
- Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
- Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication
- Network of customer contacts in therapeutic area a plus
- Finance/budgeting and resource management experience
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.