Clinical Development Director, Early Development – CardiometabolicGeneral Medicine

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.

Clinical Development Director

What you will do

Lets do this. Lets change the 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 development study start up data review monitoring and analysis activities.

Responsibilities

• Contribute to the design and implementation of the early clinical development strategy for cardiometabolic/general medicine 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 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 cardiometabolic/general medicine 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.

MD or DO degree from an accredited medical school AND

2 years of industry or academic/basic sciences/clinical research experience

• Board certification or eligible (Internal Medicine Cardiology or Endocrinology)

• Residency training in Internal Medicine and relevant subspecialty

• Understanding of cardiometabolic and general medicine pathophysiology

• 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

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.

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 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.

Salary Range