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.

MD or DO degree from an accredited medical school AND 2 years of clinical research experience and/or basic science research
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.

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.

Clinical Development Director, Chronic Weight Management

Key skills