Senior Director, Clinical Development Medical Director- Chronic Weight Management

Amgen; United States; On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Comprehensive employee benefits

Annual bonus program

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Senior Director of Clinical Development to support research in Chronic Weight Management. The role involves developing scientific evidence plans, participating in safety interactions, and managing clinical trials in a collaborative culture.

Ideal candidates will possess an MD/DO and extensive experience in clinical research and managerial roles.

Amgen offers a competitive benefits package and a commitment to employee growth.

Qualifications

• 5 years of clinical research and/or basic science research experience.
• 5 years of managerial experience managing teams, projects, or resources.

Responsibilities

• Support Clinical Development in Chronic Weight Management.
• Develop scientific/medical evidence plans globally.
• Participate in regulatory submissions and clinical trials.

Skills

Clinical research experience

Leadership

Understanding of clinical trial design

Scientific judgment

Communication skills

Education

MD or DO degree from an accredited medical school

Job description

Overview

Join Amgen’s Mission of Serving Patients. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, Amgen has helped pioneer biotech in the fight against the world’s toughest diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Disease. We reach millions of patients each year and advance a broad 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 while researching, manufacturing, and delivering innovative medicines to help people live longer, fuller lives. Our culture is collaborative, innovative, and science based.

Role

Senior Director, Clinical Development

What You Will Do

In this vital role you will support Clinical Development in Chronic Weight Management.

• Supporting the development, execution and communication of the global scientific/medical evidence plan
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Supporting the development of key scientific external relationships with opinion leaders
• Participating in safety and regulatory interactions and providing clinical input into regulatory submissions
• Providing clinical/scientific input during the development and execution of clinical trials
• Interpreting clinical trial data
• Participating in safety assessments
• Engaging in interactions with regulatory agencies
• Authoring CSRs, publications and regulatory submissions
• Developing key opinion leaders and presenting scientifically at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
• Identifying new clinical research opportunities
• Supporting in-licensing and out-licensing activities and partner relationships
• Supporting product lifecycle management for new indications as directed by Global Development Leader
• Providing clinical content input to:
  • Regulatory interactions and documents
  • Safety interactions and documents
  • Materials used in Scientific Affairs
  • Materials used by the Commercial Organization

What We Expect Of You

The clinical development professional we seek has these qualifications.

Basic Qualifications

MD or DO degree from an accredited medical school
AND 5 years of clinical research and/or basic science research experience
AND 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Preferred Qualifications

• 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in obesity, chronic weight management, sleep apnea
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Sound scientific and clinical judgment
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Demonstrated ability as a medical expert in a complex matrix environment
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

What You Can Expect Of Us

We support your professional and personal growth and well-being through competitive benefits and a collaborative culture. Salary ranges are posted; actual salary varies based on skills, experience and qualifications. Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, work-life balance, and career development opportunities.

• Comprehensive employee benefits package including Retirement and Savings Plan with company contributions, medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program, or sales-based incentive plan for field roles
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Equal Opportunity employer. Amgen 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 provide reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.