[Remote] Senior Director, Clinical Development- Chronic Weight Management

Note: The job is a remote job and is open to candidates in USA. Amgen is a leading biotechnology company dedicated to serving patients with serious illnesses. In this role as Senior Director of Clinical Development for Chronic Weight Management, you will support the development and execution of clinical programs, collaborate across functions, and engage with key opinion leaders to advance innovative treatments.

Responsibilities

• 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 and providing clinical input into safety and regulatory interactions
• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author CSRs, publications and regulatory submissions
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
• Identify new clinical research opportunities
• Support in-licensing and out-licensing activities and partner relationships
• Support product lifecycle management for new indications as directed by Global Development Leader
• Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs, Materials to be used by the Commercial Organization

Skills

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

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, 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.

Company Overview

Company H1B Sponsorship