Executive Director Observational Research, TA Head for Non Oncology

Company: Amgen
Location: Thousand Oaks
Posted on: October 12, 2020

Job Description:

Employer Amgen Location Thousand Oaks, CA, US Posted Oct 06, 2020 Ref R- Discipline Regulatory, Research/Documentation, Science/R & D Hotbed Biotech Beach, Ideal Employer Required Education Bachelors Degree Position Type Full time You need to sign in or create an account to save Executive Director Observational Research, TA Head for Non-Oncology The Executive Director of Observational Research position Is a global role based in Thousand Oaks, CA reporting to the Vice President, Center for Observational Research (CfOR) that champions strategies to enable the successful development and commercialization of Amgen's medicines. A competitive candidate for this position should be a recognized thought leader in the field of epidemiology or pharmacoepidemiology and frequently a senior author on peer-reviewed manuscripts or internal reports / regulatory filings. In addition, a competitive candidate should have a demonstrated track record of successfully recruiting, managing and developing staff, managing resources and ensuring research adheres to the highest standards of the profession. Key Responsibilities: Sets the strategic and scientific direction of the therapeutic area and contributes to the global Center's direction Contributes to the management and continuous improvement of the global Center Set annual therapeutic area goals, and develop and manage the therapeutic area budget and resource planning Promote and communicate observational research awareness and the role of the Center (internal/external; scientific/process) Contribute to the development and implementation of the organization's scientific strategy and programs; monitors progress and recommends course corrections as appropriate Speaks for the therapeutic area within Amgen and with external entitles Collaborates closely with other TA leaders in Clinical Development, Medical, CfDA, Regulatory & Safety, and Value & Access at Amgen Develop and maintain long-term relationships with key observational opinion leaders and other industry leaders Stay abreast of latest developments in the field of epidemiology in drug development and contribute to scientific advances in the field Promote understanding of stare-of-the-art epidemiological methodology and data sources Communicate and/or present scientific/technical information and knowledge to a diverse set of audiences Demonstrates creativity in meeting present goals and anticipating future needs Contribute to commercialization teams in development of product strategy, strategic product plans, clinical protocols, and filing of regulatory documents Designs and executes observational studies in the therapeutic area Develop and implement worldwide observational research strategies to advance understanding of the nature and burden of diseases, outcomes, risk factors and therapies Improves design of clinical research programs and anticipates and studies clinical safety issues pre-and post-approval Contribute to the development and implementation of risk management plans Contributes to study design, data analysis, and report preparation for safety post-marketing commitments Design and conduct studies to address safety issues and estimate background rates of adverse events of interest Basic Qualifications: Doctorate degree and 6 years of Epidemiology or related subject OR Master's degree and 10 years of Epidemiology or related subject OR Bachelor's degree and 12 years of Epidemiology or related subject AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Doctorate in Epidemiology or field with high epidemiologic content, or Medical degree with Masters degree in Epidemiology or field with high epidemiologic content 15+ years of experience post doctorate Publications in epidemiology or clinical journals 10 years of experience and demonstrated expertise in the design, execution, and analysis of epidemiology studies within the Pharmaceutical, Biotechnology, or Public Health setting in Industry, Government or Academia National reputation in the field Budget Planning and Expenditure Management Project Planning and Management Communication of Epidemiological Information (written and oral) Drug Development Process & Operations Facility with analyses of epidemiological databases Mastery of global regulatory requirements for pharmacovigilance 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 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 We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose. INNOVATIVE: Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work. REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen. COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success. REWARDING. Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded. 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. More searches like this Regulatory jobs in Thousand Oaks Research/Documentation jobs in Thousand Oaks Science/R & D jobs in Thousand Oaks

Keywords: Amgen, Thousand Oaks , Executive Director Observational Research, TA Head for Non Oncology, Healthcare , Thousand Oaks, California