Clinical Development Director, Chronic Weight Management

🕒 vor 10 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $211.176 - $285.709 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Direktor

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Amgen

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1980

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen ist ein weltweit führendes Unternehmen in der Biotechnologie, das sich auf die Entwicklung und Vermarktung innovativer Arzneimittel aus lebenden Zellen konzentriert. Das Unternehmen hat zum Ziel, schwere Krankheiten zu behandeln, wobei oft Krankheiten im Fokus stehen, für die es nur begrenzte therapeutische Möglichkeiten gibt. Amgen legt großen Wert auf wissenschaftliche Innovation und ist der ethischen Forschung, der Patientensicherheit und der ökologischen Nachhaltigkeit verpflichtet. Es ist aktiv in klinischen Studien engagiert und bekannt für seine Beiträge in den Bereichen Krebsbehandlung und Adipositas-Management unter anderem.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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.