Clinical Development Director, Early Development Inflammation/Rare Disease

BioSpace; Washington (District of Columbia); Presencial; USD 180.000 - 280.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement plan

Stock-based incentives

Bonus program

Time-off plans

Flexible work models

Descripción de la vacante

Amgen seeks a Clinical Development Director to lead early phase clinical development from first-in-human studies through proof-of-concept. You will collaborate with multidisciplinary teams to design and deliver early phase trials and contribute to protocol and IND development, safety reviews, and data interpretation.

The role requires MD/DO and 2+ years in clinical development, with strong leadership and regulatory knowledge.

Formación

• MD or DO degree from an accredited medical school and
• 2 years of industry or academic/basic sciences/clinical development experience
• Experience in leading early phase clinical trials and collaboration with cross-functional teams

Responsabilidades

• Lead early phase clinical development from first-in-human studies through proof-of-concept
• Collaborate on protocol development, IND submissions, and study start-up activities
• Review safety, efficacy, pharmacodynamics and pharmacokinetics data
• Guide external partnerships and licensing opportunities in targeted therapeutic areas
• Work with cross-functional teams including Precision Medicine, Regulatory, Safety and Clinical Operations

Conocimientos

Clinical development

Leadership

Regulatory knowledge

Biotech industry

Educación

MD/DO degree

Descripción del empleo

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

Lets do this. Lets 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

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

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 will support your journey every step of the way.

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.

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 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.