Medical Director-Early Development Inflammation

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. 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.

Medical Director-Early Development Inflammation

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for providing scientific/ medical direction and leadership for pre-clinical/ early clinical programs for Amgen’s Early Development Inflammation pipeline. The Medical Director will lead the early phase clinical development of compounds from first-in-human studies through proof-of- concept and translational projects as part of the initial drug development strategy. This individual will also serve as the Evidence Generation Team leader for one or more of Amgen’s Product Teams through their role as an Early Development Leader (EDL)

Responsibilities include:

• Design and implement innovative early clinical development strategy for Inflammation indications (e.g., respiratory, rheumatologic, inflammatory bowel disease, others)
• Effectively network with internal and external opinion leaders
• Opportunity to explore additional therapeutic areas
• Lead the preparation of clinical development plans and clinical study protocols, and contribute to informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions
• Serve as the Medical Monitor on early clinical trials; review and evaluate clinical study safety, efficacy, pharmacokinetic and pharmacodynamic data
• Actively collaborate with Amgen Late Development, Research, Precision Medicine, Regulatory, Commercial and Business Development colleagues
• Collaborate with external experts to provide biomedical expertise and strategic guidance to inflammation early development teams
• Contribute to in-licensing evaluations and due-diligence activities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research and/or basic science research experience

Preferred Qualifications:

• Board certification or eligible
• Residency training in Internal Medicine and relevant subspecialty
• 3+ years of Inflammation drug development experience in the pharmaceutical industry and/or collaborating with pharmaceutical sponsors
• Experience in clinical trial design, implementation and/or interpreting trial results
• Demonstrated leadership qualities
• Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet ambitious timelines
• Understanding of and/or experience directing/interpreting early clinical trials
• Experience in both basic research and clinical trial methodology
• Publication track record
• Excellent interpersonal and presentation skills
• Communicate effectively with internal stakeholders, as well as, external partners and collaborators

What you can expect of us

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, 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 deve