Clinical Development Director, Early Development – Inflammation/Rare Disease

Amgen Inc. (IR); Northern (KY); Hybrid; USD 275,000 - 372,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible

Job summary

Amgen Inc. (IR) seeks a Clinical Development Director to lead early phase studies from first-in-human through proof-of-concept.

You will design and support INDs, study start-up, data review, and safety analyses while collaborating with Precision Medicine, Research, and Regulatory teams. Ideal candidates will have MD/DO with 3+ years in pharma/academia, clinical trial methodology experience, and strong leadership, communication, and publication credentials.

Qualifications

• MD or DO with 2 years of industry or academic clinical development experience.
• Board certification or eligible (Internal Medicine or subspecialty) preferred.
• Residency in Internal Medicine/subspecialty preferred.
• Understanding of pathophysiology in inflammatory/general medicine/rare diseases.
• Experience in basic research and/or clinical trial methodology.
• 3+ years of drug development experience in pharma/academia, ideally in early stage trials.
• Experience collaborating with sponsors and cross-functional teams.
• Experience designing, monitoring and interpreting clinical trials; strong leadership in matrix environments.
• Publication track record and excellent communication with stakeholders.

Responsibilities

• Lead early phase clinical development of compounds from FIH to proof-of-concept.
• Collaborate on design and delivery of early phase trials and protocol/IND development.
• Support study start-up, data review, monitoring and analysis activities.
• Contribute to clinical development plans and regulatory submissions.
• Collaborate with Internal Medicine, Rare Disease, and other teams; evaluate external licensing opportunities.
• Provide biomedical guidance to Early Development teams and external experts.

Skills

Leadership qualities

Interpersonal skills

Presentation skills

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

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 www.amgen.com and follow us on www.twitter.com/amgen