Associate Director Study Start-up

Amgen

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profile Job Location:

Thousand Oaks, CA - USA

profile Monthly Salary: $ 182145 - 212860
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

Career Category

Clinical

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980wevehelped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen teamyoullhelp make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within themyoullthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Study Start Up Hub Associate Director Study Start-up

What you will do

Letsdo this.Letschange the world. In this vital role you willdrive world-class study start-upplanning andexecution across a global portfolio ensuring clinical trials launch with quality efficiency andspeed.

  • Lead andmanage a team of Study Start-up Managers ensuring high-quality compliant study start-up delivery across multiple programs and therapeutic areas.

  • Drive end-to-end study start-upplanning andexecution from global to local delivering milestones on time within budget and in line with ICH-GCP and regulatory requirements.

  • Provide portfolio-level oversight of study start-up performance resourcing and delivery metrics escalating risks with solution-focused recommendations.

  • Build team capability through coaching mentoring performance management and role modelling of best practices in study start-up delivery.

  • Partner with functional and hub leaders to strengthen study start-up capabilities ways of working and operational readiness across the organisation.

  • Own and embed study start-up business processes ensuring consistent application through training knowledge sharing and continuous improvement.

  • Foster a collaborative high-engagement culture that encourages innovation learning and the sharing of knowledge and best practice.

  • Contribute to the evolution of the Study Start-up Hub model shaping future ways of working through feedback insights and continuous improvement initiatives.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. Thecandidateweseekisan individualwith the following qualifications.

Basic Qualifications:

  • Pharma Expertise:Requires pharma and clinical trial processes and operationsexpertise; no relevant therapeutic knowledge

  • Management Experience:Requires experience leading and managing global teams and project management experience

  • Tech Skills:No prior Veeva experience

  • Doctorate degree and 3 years of clinical execution experience OR

  • Masters degree and 7 years of clinical execution experience OR

  • Bachelors degree and 9 years of clinical execution experience OR

  • Associates degree and 12 years of clinical execution experience OR

  • High school diploma / GED and 14 years of clinical execution experience

  • In addition to meeting at least one of the above requirements you must have a minimum of 3years experiencedirectly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

  • 7yearswork experience in life sciences industry particularly focusing on clinical trial work including 5 years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company

  • Experience managing multiple teams / direct reports across multiple clinical functions

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culturewellsupport your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $182145 - $212860.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibilitycomprisingof 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 that may include:

  • 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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against seriousdisease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

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Required Experience:

Director

Career CategoryClinicalJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980wevehelped pioneer the world of biotech in our fight...
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Key Skills

  • Program assessment
  • FDA Regulations
  • Manufacturing & Controls
  • Program Evaluation
  • budget forecast
  • Research Experience
  • Operations Management
  • Research & Development
  • Strategic Planning
  • Contract Management
  • Leadership Experience
  • negotiation

About Company

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Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more

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