Executive Medical Director, Early Dev - Inflammation
Amgen
Executive Medical Director, Early Dev - Inflammation
Job Description
Career CategoryClinical DevelopmentJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.As a member of the Amgen team, you’ll help 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 them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Executive Medical Director, Early Development – InflammationWhat you will doAmgen is advancing a broad/deep pipeline of Inflammation programs spanning multiple modalities. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients. Let’s do this. Let’s change the world. In this vital role the Executive Medical Director you will serve as an Early Development Inflammation Portfolio lead for key assets in the Amgen portfolio. You will serve as the principal representative for an early development portfolio to a range of audiences, including executive leadership, development partners, and global regulatory agencies. You will develop and translate Inflammation development program strategies into the design and implementation of clinical studies that can be executed without compromising scientific rigor. The Executive Medical Director will report into the Associate Vice President, Early Development. Responsibilities Develop an Early Development Inflammation team in collaboration with the Early Development Therapeutic Area Head Ensure the best way to develop and prosecute an early development portfolio Drive the timely execution of multiple assets and studies within the early development portfolio Ensure strategy and execution, and partner closely with Research, Translational Safety (toxicology), Precision Medicine, Clinical Pharmacology, Biostatistics, and Clinical Operations colleagues Partner closely with Regulatory leaders to support regulatory interactions and develop regulatory strategies Keep major stakeholders and other senior management updated as the portfolio evolves and matures Guide their team to think broadly as they create innovative portfolio development strategy options. Ensure all avenues and options have been explored and evaluated before final recommendations are sent for review by senior leadership Oversee activities related to planning for studies including execution and oversight of study outlines and Protocols for early development clinical studies Collaborate with Business Development colleagues in the evaluation of external opportunities. Mentor, coach, and supervise the performance of direct reports to build a highly skilled, diverse, and inclusive team, leading and motivating staff in a complex, multi-functional matrix environment What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.Basic Qualifications:MD or DO from an accredited medical school AND Five (5) years of industry or academic research AND Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesPreferred Qualifications:MD or MD/PhD plus accredited residency in relevant sub-specialty, board certified or equivalent Relevant subspecialty board eligibility/certification or equivalent Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials Ability to anticipate problems and find creative solutions In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints A record of high-quality peer-reviewed publications Experience functioning as a medical expert in a complex matrixed environment Previous experience in conducting translational and/or clinical research for both small molecules and large molecules History of solving problems while exhibiting judgment and a balanced, realistic understanding of issues including the ability to anticipate problems and find creative solutions Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements Knowledgeable in current and possible future, trends, technology, policies, practices and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication Understanding of resource and budgeting They will also embody the Amgen leadership attributes which are:Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thriveAccelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfectionIntegrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholdersAdapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver resultsWhat you can expect of usAs 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 culture, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. is $333,957- $451,824.Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.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 serious disease.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 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..Salary Range333,956.50USD -451,823.50 USD
Locations
- US - California - Thousand Oaks
Salary
333,957 - 451,824 USD / yearly
Skills Required
- biopharmaceutical industryintermediate
- biomarker methodsintermediate
- Good Clinical Practicesintermediate
Required Qualifications
- MD or DO from an accredited medical school AND (experience)
- Five (5) years of industry or academic research AND (experience)
- Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources (experience)
- MD or DO from an accredited medical school AND (experience)
- Five (5) years of industry or academic research AND (experience)
- Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources (experience)
Preferred Qualifications
- MD or MD/PhD plus accredited residency in relevant sub-specialty, board certified or equivalent (degree in md)
- Relevant subspecialty board eligibility/certification or equivalent (certification)
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) (experience)
- Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities (experience)
- Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials (experience)
- Ability to anticipate problems and find creative solutions (experience)
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints (experience)
- A record of high-quality peer-reviewed publications (experience)
- Experience functioning as a medical expert in a complex matrixed environment (experience)
- Previous experience in conducting translational and/or clinical research for both small molecules and large molecules (experience)
- History of solving problems while exhibiting judgment and a balanced, realistic understanding of issues including the ability to anticipate problems and find creative solutions (experience)
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements (experience)
- Knowledgeable in current and possible future, trends, technology, policies, practices and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval (experience)
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication (experience)
- Understanding of resource and budgeting (experience)
- MD or MD/PhD plus accredited residency in relevant sub-specialty, board certified or equivalent (degree in md)
- Relevant subspecialty board eligibility/certification or equivalent (certification)
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) (experience)
- Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities (experience)
- Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials (experience)
- Ability to anticipate problems and find creative solutions (experience)
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints (experience)
- A record of high-quality peer-reviewed publications (experience)
- Experience functioning as a medical expert in a complex matrixed environment (experience)
- Previous experience in conducting translational and/or clinical research for both small molecules and large molecules (experience)
- History of solving problems while exhibiting judgment and a balanced, realistic understanding of issues including the ability to anticipate problems and find creative solutions (experience)
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements (experience)
- Knowledgeable in current and possible future, trends, technology, policies, practices and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval (experience)
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication (experience)
- Understanding of resource and budgeting (experience)
- They will also embody the Amgen leadership attributes which are: (experience)
- Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive (experience)
- Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection (experience)
- Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders (experience)
- Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results (experience)
- Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive (experience)
- Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection (experience)
- Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders (experience)
- Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results (experience)
Responsibilities
- Amgen is advancing a broad/deep pipeline of Inflammation programs spanning multiple modalities. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.
- Let’s do this. Let’s change the world. In this vital role the Executive Medical Director you will serve as an Early Development Inflammation Portfolio lead for key assets in the Amgen portfolio. You will serve as the principal representative for an early development portfolio to a range of audiences, including executive leadership, development partners, and global regulatory agencies. You will develop and translate Inflammation development program strategies into the design and implementation of clinical studies that can be executed without compromising scientific rigor.
- The Executive Medical Director will report into the Associate Vice President, Early Development.
- Develop an Early Development Inflammation team in collaboration with the Early Development Therapeutic Area Head
- Ensure the best way to develop and prosecute an early development portfolio
- Drive the timely execution of multiple assets and studies within the early development portfolio
- Ensure strategy and execution, and partner closely with Research, Translational Safety (toxicology), Precision Medicine, Clinical Pharmacology, Biostatistics, and Clinical Operations colleagues
- Partner closely with Regulatory leaders to support regulatory interactions and develop regulatory strategies
- Keep major stakeholders and other senior management updated as the portfolio evolves and matures
- Guide their team to think broadly as they create innovative portfolio development strategy options. Ensure all avenues and options have been explored and evaluated before final recommendations are sent for review by senior leadership
- Oversee activities related to planning for studies including execution and oversight of study outlines and Protocols for early development clinical studies
- Collaborate with Business Development colleagues in the evaluation of external opportunities.
- Mentor, coach, and supervise the performance of direct reports to build a highly skilled, diverse, and inclusive team, leading and motivating staff in a complex, multi-functional matrix environment
- Develop an Early Development Inflammation team in collaboration with the Early Development Therapeutic Area Head
- Ensure the best way to develop and prosecute an early development portfolio
- Drive the timely execution of multiple assets and studies within the early development portfolio
- Ensure strategy and execution, and partner closely with Research, Translational Safety (toxicology), Precision Medicine, Clinical Pharmacology, Biostatistics, and Clinical Operations colleagues
- Partner closely with Regulatory leaders to support regulatory interactions and develop regulatory strategies
- Keep major stakeholders and other senior management updated as the portfolio evolves and matures
- Guide their team to think broadly as they create innovative portfolio development strategy options. Ensure all avenues and options have been explored and evaluated before final recommendations are sent for review by senior leadership
- Oversee activities related to planning for studies including execution and oversight of study outlines and Protocols for early development clinical studies
- Collaborate with Business Development colleagues in the evaluation of external opportunities.
- Mentor, coach, and supervise the performance of direct reports to build a highly skilled, diverse, and inclusive team, leading and motivating staff in a complex, multi-functional matrix environment
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