BioSpace
Clinical Research Medical Director, Cardiometabolic
BioSpace, Washington, District of Columbia, us, 20022
Clinical Research Medical Director, Cardiometabolic
Join Amgen's mission of serving patients.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while advancing your career.
What You Will Do In this vital role you will support the development, execution, and communication of the global scientific/medical evidence plan. Support cross‑functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program. Support the development of key scientific external relationships with opinion leaders. Participate in and provide clinical input into safety and regulatory interactions.
Provide clinical/scientific input during the development and execution of clinical trials
Interpret clinical trial data
Participate in safety assessments
Participate in interactions with regulatory agencies
Author CSRs, publications, and regulatory submissions
Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings, and external committee meetings as delegated by GDL
Identify new clinical research opportunities
Support in‑licensing and out‑licensing activities and partner relationships
Support product lifecycle management for new indications as directed by Global Development Leader
Provide clinical content input to regulatory interactions and documents, safety interactions and documents, materials for Scientific Affairs, and materials for the Commercial organization
Basic Qualifications MD or DO degree from an accredited medical school.
AND
2 years of clinical research experience and/or basic science research.
Preferred Qualifications
Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical, or CRO company).
Five or more years of clinical research experience and/or basic science research combined with clinical instructing and patient care activities.
Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in a relevant subspecialty.
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
Experience with developing study concepts for clinical development and clinical trial designs with cross‑functional input, including biostatistics, observational research, and patient‑reported outcomes in Phase 1, 2, and/or 3 clinical trials in obesity or diabetes.
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
Leadership experience/potential as a medical expert in a complex matrix environment.
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
Strong interpersonal skills and problem‑solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution paths.
What You Can Expect From Us As we work to develop treatments that take care of others, we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we 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 factors including but not limited to relevant skills, experience, and qualifications.
Benefits In addition to the base salary, Amgen offers a total rewards plan, 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, including remote and hybrid work arrangements, where possible.
Application Information Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Health Care Provider
Industries: Internet News
#J-18808-Ljbffr
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while advancing your career.
What You Will Do In this vital role you will support the development, execution, and communication of the global scientific/medical evidence plan. Support cross‑functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program. Support the development of key scientific external relationships with opinion leaders. Participate in and provide clinical input into safety and regulatory interactions.
Provide clinical/scientific input during the development and execution of clinical trials
Interpret clinical trial data
Participate in safety assessments
Participate in interactions with regulatory agencies
Author CSRs, publications, and regulatory submissions
Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings, and external committee meetings as delegated by GDL
Identify new clinical research opportunities
Support in‑licensing and out‑licensing activities and partner relationships
Support product lifecycle management for new indications as directed by Global Development Leader
Provide clinical content input to regulatory interactions and documents, safety interactions and documents, materials for Scientific Affairs, and materials for the Commercial organization
Basic Qualifications MD or DO degree from an accredited medical school.
AND
2 years of clinical research experience and/or basic science research.
Preferred Qualifications
Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical, or CRO company).
Five or more years of clinical research experience and/or basic science research combined with clinical instructing and patient care activities.
Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in a relevant subspecialty.
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
Experience with developing study concepts for clinical development and clinical trial designs with cross‑functional input, including biostatistics, observational research, and patient‑reported outcomes in Phase 1, 2, and/or 3 clinical trials in obesity or diabetes.
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
Leadership experience/potential as a medical expert in a complex matrix environment.
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
Strong interpersonal skills and problem‑solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution paths.
What You Can Expect From Us As we work to develop treatments that take care of others, we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we 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 factors including but not limited to relevant skills, experience, and qualifications.
Benefits In addition to the base salary, Amgen offers a total rewards plan, 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, including remote and hybrid work arrangements, where possible.
Application Information Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Health Care Provider
Industries: Internet News
#J-18808-Ljbffr