#WeareBiotech
Senior Director, Clinical Development – Chronic Weight Management
Location
United States
Posted
2 days ago
Salary
$302.3K - $409.0K / year
Seniority
Senior
Job Description
Senior Director, Clinical Development – Chronic Weight Management
Amgen
• 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 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.
Job Requirements
- 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
- 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.
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