About this opportunity
Amgen lists this Clinical Development Director, Early Development – Inflammation/Rare Disease opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Career Category Clinical Development Job Description
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. 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, 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Clinical Development Director
What you will do
Let’s do this. Let’s change the world. In this vital role, you will lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. You will collaborate on teams to support the design and delivery of early phase clinical trials. Through this role, the Clinical Medical Director will support protocol and IND development, study start up, data review, monitoring and analysis activities.
Responsibilities
Contribute to the design and implementation of the early clinical development strategy for Inflammation, General Medicine or Rare Disease therapeutic candidates
Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions
Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data
Contribute to the strategy and use of clinical biomarkers to facilitate drug development
Actively collaborate with Amgen Precision Medicine, Research, Clinical Pharmacology, Operations, Late Development, Regulatory, Safety and Commercial colleagues
Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas
Collaborate with external experts to provide biomedical expertise and strategic guidance to Early Development teams
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Early Development professional we seek is a Leader with these qualifications.
Basic Qualifications
MD or DO degree from an accredited medical school AND 2 years of industry or academic/basic sciences/clinical development experience
Preferred Qualifications
Board certification or eligible (Internal Medicine, relevant subspecialty)
Residency training in Internal Medicine and relevant subspecialty
Understanding of pathophysiology of inflammatory, general medicine, and/or rare diseases
Experience in basic research and/or clinical trial methodology
3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials
Experience collaborating with pharmaceutical sponsors
Experience in designing, monitoring and implementing clinical trials and interpreting trial results
Demonstrated leadership qualities; capable of conducting studies as part of a team
Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines
Publication track record
Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators
What you can expect of us
From our competitive benefits to our collaborative culture, we’ll 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.
Benefits
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
Flexible spending accounts
A discretionary annual bonus program
For field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Sponsorship
Sponsorship for this role is not guaranteed.
Equal Opportunity Employment
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.
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.
Policy
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.
Salary Range
274,788.85USD -371,773.15 USD
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit and follow us on
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.