Amgen

Global Clinical Program Mgt Director, Head of Observational Research

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 20, 2019
Ref
R-79242
Required Education
Bachelors Degree
Position Type
Full time
The Director will coordinate and oversee the execution of global, and regional observational research executed by GCPM (Global Clinical Program Management) and conduct in accordance with the Global Development Plan or other strategic documents.

Responsibilities:

Ensure global coordination and that the planning, execution, and reporting of observational clinical studies are performed with high quality (globally and in their region)

Oversee consistency across observational studies, functions, and regions in study planning, set-up and execution, including vendor management, project management, and coordination of study implementation plans

Lead observational clinical study process development activities including

authoring and/or review of SOPs, Manuals, Forms, trainings to support all types of Observational research e.g. registries, prospective studies, technology assessments,

Develop GSM Observational Research goals and metrics

Build relationships with key stakeholders ( Center For Observational Research, Global Medical Organization, Digital Health, TAs) and working collaboratively to find innovative solutions to study design and delivery

Represent observational research as requested at the GDT (Global Development Team)and provide operational input to development plans, contribute to goal setting and review of observational study operational status

Line management of Sr. Mgr Observational Research Operations Mentoring/training/career development of direct reports and the team

Oversight of observational study budgets and active management resourcing models to support the study designs

Ensure that the execution of observational research in GCPM is done with high quality, on time, and within budget

Basic Qualifications:

Doctorate degree and 4 years of Clinical experience

OR

Master's degree and 8 years of Clinical experience

OR

Bachelor's degree and 10 years of Clinical experience

AND

4 years of direct managerial and/or leadership experience

Preferred Qualifications:

M.D., D.O., PhD, PharmD, Master's Degree

11+ years work experience in life sciences or medically related field including:

8+ years of biopharmaceutical clinical research experience (obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Experience overseeing or directly executing observational research in an industry setting

Previous management experience of direct reports, including management

level staff

Experience at, or oversight of, clinical research vendors (CRO's, central labs, imaging vendors, etc.)

Experience driving and leading process development and /or improvement

Knowledge of observational research execution challenges and best practices

Experience working in a global, matrix organization on a global/international clinical development program

Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice from an operational perspective Proficiency in developing and overseeing clinical studies involving complex design issues

Extensive knowledge of Good Clinical Practice (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines

Understanding of Australian, Canadian, Japanese, and European regulatory requirements and differences in clinical practice patterns as they relate to clinical study design and execution

Knowledge of international regulatory requirements

Extensive project management/project planning experience overseeing clinical program deliverables, budgets, and timelines

Ability to provide operational and clinical expertise into a clinical development program and evaluate clinical strategies for the product

Proficiency in anticipating and resolving problems

Experience writing and presenting clearly on scientific and clinical issues

Experience leading teams in a matrix environment

Excellent interpersonal organizational, supervisory skills

Professional collaboration and leadership skills

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:
  • Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
  • Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
  • Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
  • Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
  • Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
  • Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans
  • Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
  • Resolving critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting
  • Identifying diverse, qualified successors for key positions
  • Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

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 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.