BioSpace
Clinical Research Medical Sr. Director, Thoracic Oncology
BioSpace, Washington, District of Columbia, us, 20022
Clinical Research Medical Sr. Director, Thoracic Oncology
Overview Clinical Research Medical Sr. Director - Thoracic Oncology role focused on the development and leadership of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indications, providing clinical and scientific expertise throughout development, delivery, and communication. What You Will Do
In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indication(s). Additional responsibilities include: Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team. Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies. Integral contribution to SCLC product team. Manage a clinical development team of clinical research medical directors and medical science directors. Provide medical leadership for clinical trials and develop and implement strategies to drive patient enrollment in partnership with clinical operations and medical affairs organizations. Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s). Participate and provide clinical input into safety and regulatory interactions. Interpret and communicate clinical trial data. Lead authoring and review of CSRs, publications and regulatory submissions. Develop key opinion leaders and present scientifically at advisory boards, key scientific meetings and external committee meetings. Identify new clinical research opportunities. Provide clinical content input to materials used in Scientific Affairs as well as the Commercial Organization. Approximate 10% travel may be required. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications
MD or DO degree from an accredited medical school 5 years of clinical research and/or basic science research experience 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications
MD plus accredited residency and fellowship training in oncology, board certified or equivalent. Five (5) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities. Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company). Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization. Involved in filing activities as part of moving the program through the development lifecycle. Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders. Previous management experience of clinical development professionals. 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 culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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 comprising health and welfare plans for staff and eligible dependents, financial plans with retirement savings opportunities, work/life balance, and career development opportunities. Benefits may include: comprehensive employee benefits package (retirement plan, medical/dental/vision, life and disability insurance, FSA), discretionary bonuses, stock-based incentives, time-off programs, and flexible work models where possible. Amgen is an Equal Opportunity employer. We will consider all qualified applicants 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. Reasonable accommodations are available to applicants with disabilities during the application or interview process. Application deadline: Amgen does not have a fixed deadline; we continue accepting applications until a candidate is selected. We value an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to advance science and serve patients.
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Overview Clinical Research Medical Sr. Director - Thoracic Oncology role focused on the development and leadership of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indications, providing clinical and scientific expertise throughout development, delivery, and communication. What You Will Do
In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indication(s). Additional responsibilities include: Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team. Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies. Integral contribution to SCLC product team. Manage a clinical development team of clinical research medical directors and medical science directors. Provide medical leadership for clinical trials and develop and implement strategies to drive patient enrollment in partnership with clinical operations and medical affairs organizations. Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s). Participate and provide clinical input into safety and regulatory interactions. Interpret and communicate clinical trial data. Lead authoring and review of CSRs, publications and regulatory submissions. Develop key opinion leaders and present scientifically at advisory boards, key scientific meetings and external committee meetings. Identify new clinical research opportunities. Provide clinical content input to materials used in Scientific Affairs as well as the Commercial Organization. Approximate 10% travel may be required. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications
MD or DO degree from an accredited medical school 5 years of clinical research and/or basic science research experience 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications
MD plus accredited residency and fellowship training in oncology, board certified or equivalent. Five (5) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities. Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company). Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization. Involved in filing activities as part of moving the program through the development lifecycle. Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders. Previous management experience of clinical development professionals. 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 culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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 comprising health and welfare plans for staff and eligible dependents, financial plans with retirement savings opportunities, work/life balance, and career development opportunities. Benefits may include: comprehensive employee benefits package (retirement plan, medical/dental/vision, life and disability insurance, FSA), discretionary bonuses, stock-based incentives, time-off programs, and flexible work models where possible. Amgen is an Equal Opportunity employer. We will consider all qualified applicants 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. Reasonable accommodations are available to applicants with disabilities during the application or interview process. Application deadline: Amgen does not have a fixed deadline; we continue accepting applications until a candidate is selected. We value an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to advance science and serve patients.
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