- Ensure excellence and consistency in clinical trial execution across Clinical Program Operations
- Serve as the primary point of contact for clinical trial execution for Early Development programs
- Partner closely with Global Development Therapy Areas Heads to ensure operational considerations are incorporated into clinical trial design
- Build and develop a high performing CPO team
- Champion the delivery of CPO sub functions in supporting clinical trial execution
- Ensure operational efficiency and compliance with R&D Standards and training requirements / inspection readiness
- Promote and lead continuous improvement in Clinical Program Operations and throughout Global Development Operations (GDO)
- Developing and mentoring staff to enhance study management skills & actively promote study management best practices
- Clinical Program Operations strategy, planning, risk assessment and mitigation, and overall execution within budget and with quality
- Ensuring that programs and sub functions (e.g. NASCR/ OR) are appropriately resourced in alignment with program prioritization.
- All performance management tasks for direct reports, including robust talent management, alignment, and calibration.
- Managing program-level operational issues and oversight of study team issue escalation
- Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management
- Represent CPO (and GDO as appropriate) on organizational and/or process improvement initiatives.
- Manage CPO budget, headcount, hiring, resourcing, and goal setting
- Partner with relevant Early / Clinical Development Leads and their senior staff to ensure alignment and achievement of company goals and objectives.
- Oversee global clinical research execution activities within CPO therapy area
- Ensure Program or Study Operational Preparedness are held for priority programs
- Identify issues related to study execution and assist the staff in their resolution
- Communicate escalation of study execution issues to management and the relevant Leadership, as appropriate
- Ensuring subfunctions (e.g NASCR/ OR) are supported and their delivery aligns with portfolio prioritization
- Contribute to interpretation of study feasibility and clinical trial placement decisions
- Collaborate cross-functionally to identify areas for process improvement in clinical study execution and contribute to the optimization of these processes
- Lead global alignment and consistency for CPO
- Identify areas for and drive process improvement and standardization across GDO
- Mentor and develop departmental staff/establish succession plans
- Conduct performance management and performance reviews
- Contribute to the development of relevant policies, SOPs and associated documents
- Identify training/staff development and oversee the implementation of training plans including Role-Based Curriculum
- Remain current and input into Industry best practices
- Lead functional insourcing/outsourcing decisions
- Lead the development of CPO metrics and reporting
- Promote global and innovative working practices
- Contribute to broader strategic organizational considerations as a member of both the GDO and Translational Medicine Senior Leadership Teams
- Participate in service provider evaluation (as needed) and management
- Ensure representation of CPO at Operation/Functional Management teams (OMT/FMT) to identify cross-study issues requiring resolution by the vendor and/or Amgen
- Doctorate degree & 6 years of clinical program experience OR
- Masters degree & 10 years of clinical program experience OR
- Bachelors degree & 12 years of clinical program experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Degree educated - M.D., D.O., PhD, PharmD, masters degree
- Extensive clinical research/clinical trial experience
- Proven experience of directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Extensive experience in life sciences or medically related field, including biopharmaceutical clinical research (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
- Previous management experience of direct reports, including management level staff
- Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.)
- Mastery of global regulatory requirements and guidelines for conducting clinical research and safety monitoring/reporting
- Experience developing goals and training plans to maximize talent management/career development of clinical research staff
- Ability to network and build relationships to maximize organizational function and capabilities
- Experience leading organizations through change
- Experience working with international teams on multinational programs
- Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
- Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
- Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
- Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
- 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
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Executive Director Clinical Program Operations - Uxbridge, United States - BioSpace
Description
Job DetailsHOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Executive Director, Clinical Program Operations, General Medicine
Live
What you will do
Lets do this. Lets change the world. In this vital role as Executive Director, you will be a part of the Clinical Program Operations Senior Leadership Team. You will serve as the primary point of contact for clinical trial execution within General medicine TA and the Observational Research (OR) and Non-Amgen Sponsored Clinical Research (NASCR) teams, responsible for ensuring consistency in clinical trial execution across Clinical Program Operations (CPO).
Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications.
Basic Qualifications:
What you can expect of us
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.
The annual base salary range for this opportunity in the U.S. is $265,526-$325,545.
In addition to the base salary, 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:
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.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
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. Please contact us to request accommodation.
