Senior Director, Clinical Development- Chronic Weight Management

Responsibilities

• Supporting the development, execution and communication of the global scientific/medical evidence plan
• S 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

Qualifications

• 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.

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