Clinical Research Medical Director, Late Development Blinatumomab - Washington DC, United States - Amgen

Description

It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Clinical Research Medical Director****This remote role will report directly to the Global Development Lead (GDL) for Blinatumomab.

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan including protocol development for blinatumomab.
• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Participate, present, and provide clinical input into safety and regulatory interactions as delegated by GDL
• Participate in drafting of development plans including Pediatric Investigational Plan for EMA and Pediatric Written Request for FDA as delegated by GDL
• Interpret and communicate clinical trial data
• Author CSRs, publications, and regulatory submissions
• Develop and maintain relationship with key opinion leaders and give scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by GDL
• Identify new clinical research opportunities
• Support product lifecycle management for new indications as directed by GDL
• Provide clinical input for medical, commercial and access resources related to blinatumomab
• Serve as medical monitor as designated by GDL

**MD or DO degree from an accredited medical school
2 years of clinical research experience and/or basic science research
**MD with strong and versatile clinical development experience in hematology and oncology, and accreditation in at least one sub-specialty.

• Expertise in managing patients with hematologic malignancies will be an asset
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
• Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1,2 and/or 3 clinical trials
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Leadership experience/potential as a medical expert in a complex matrix environment
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

**Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.