Clinical Development Director, Obesity/Cardiovascular

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 180,000 - 250,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Stock-based incentives

Discretionary bonus program

Paid time off

Job summary

Amgen Inc. in Thousand Oaks, CA, seeks a Clinical Development Director for Obesity/Cardiovascular to lead late‑phase studies and shape the global evidence generation plan.

You will report to the Global Development Lead and work cross‑functionally to translate strategy into study concepts, protocols and regulatory submissions. You will provide clinical input on safety data, interact with regulators, and develop relationships with key opinion leaders while guiding medical monitoring and

Qualifications

• MD or DO degree from an accredited medical school and 3+ years of clinical research experience.
• Experience in biopharmaceutical industry, preferably late phase in cardiometabolic areas.
• Knowledge of pharmaceutical product development, lifecycle and regulatory submissions.

Responsibilities

• Lead the clinical development strategy for obesity/cardiometabolic programs.
• Develop study concepts, protocols and related development documents.
• Act as medical monitor and review clinical trial data for quality and safety.
• Author clinical study reports and regulatory submissions; present at meetings.

Skills

Clinical research

Medical leadership

Communication skills

Regulatory knowledge

GCP/fda knowledge

Cross-functional collaboration

Data interpretation

Education

MD/DO degree

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, Obesity/Cardiovascular

What you will do

Let’s do this. Let’s change the world. Amgen is advancing our Obesity and Cardiometabolic pipeline. We need collaborative and innovative world‑class talent to ensure these molecules become medicines and reach their full potential while helping patients. The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications. Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for maridebart cafraglutide (AMG 133) phase 3 program(s). Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents. Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. Serve as medical monitor for ongoing clinical trials. Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements. Participate and provide clinical input into safety and regulatory interactions. Author clinical study reports, publications and regulatory submissions. Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead.

What we expect of you

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

Basic Qualifications

• MD or DO degree from an accredited medical school AND 3 years of clinical research experience

Preferred Qualifications

• Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), ideally in late phase development in a cardiometabolic or adjacent therapeutic area.
• Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• 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 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications
• Experience with clinical trial medical data review, medical monitoring and or safety review and interpretation, including use of electronic aggregate data review tools
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
• Strong communication & presentation skills to clearly communicate scientific 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 path
• 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

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 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.

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.

Equal Opportunity Employer

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

. Salary Range USD - USD 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 www.amgen.com and follow us on www.twitter.com/amgen.

Application Guidance

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.