BioSpace
Clinical Research Medical Sr. Director, Thoracic Oncology
BioSpace, Washington, District of Columbia, us, 20022
Clinical Research Medical Sr. Director, Thoracic Oncology
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 make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
Identify new clinical research opportunities.
Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization.
Approximate 10% travel may be required.
We are looking for a leader with the following 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 the 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.
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.
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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 make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
Identify new clinical research opportunities.
Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization.
Approximate 10% travel may be required.
We are looking for a leader with the following 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 the 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.
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.
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