Lantheus
Senior Medical Director, Oncology Drug Development
Lantheus, Bedford, Massachusetts, us, 01730
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.Summary of RoleLantheus, a leading innovator in radiopharmaceuticals, is seeking a Senior Medical Director, Oncology Drug Development to join our team. This pivotal individual contributor role will focus on clinical development planning, encompassing disease area strategy and asset development strategy for our expanding pipeline of oncology products. The ideal candidate will have extensive experience in clinical trial design, protocol writing, and execution specifically within the fields of oncology and radiopharmaceuticals.Key Responsibilities/Essential FunctionsClinical Development Strategy:
Develop and execute strategic clinical development plans for Lantheus's oncology drug candidates in alignment with overall company objectives and vision.Lead the formulation of comprehensive disease area strategies that focus on unmet clinical needs and optimize pathways for successful product development.
Asset Development:
Oversee asset development strategies, ensuring each project has a clear path from preclinical to post-market stages, while integrating learning and feedback into ongoing trials.Manage strategic interactions with cross-functional teams to align objectives related to regulatory strategy, clinical operations, and commercial considerations.
Protocol Development and Trial Management:Write and review clinical trial protocols and associated documents to ensure scientific rigor and regulatory compliance.Directly oversee the initiation and conduct of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.
Regulatory Submissions:Produce high-quality documentation for regulatory submissions, including INDs, CTAs, NDAs, and MAAs, to facilitate communication with regulatory authorities.Ensure that all submissions and interactions meet the rigorous standards expected by regulatory bodies and align with best practices.
Mentorship and Leadership:Provide strategic guidance and mentorship to junior team members, fostering an environment of professional growth and teamwork. Manage 1-2 direct reports if assigned.Ensure continuous professional development of team members through coaching and training on clinical trial management and regulatory processes.
Due Diligence and Business Development:Participate in due diligence reviews for potential business development opportunities, providing insights and recommendations based on clinical data and development strategies.Engage in discussions with potential partners or investors to present Lantheus's oncology product strategies and evidence of clinical efficacy.
Data Analysis and Reporting:Analyze clinical data and outcomes to inform therapeutic strategies and decision-making processes within the oncology portfolio.Prepare and present findings to executive leadership and external stakeholders, including participation in scientific conferences and publications.
Basic QualificationsM.D. in a relevant scientific field; board certification in Medical Oncology is highly preferred.A minimum of 5 years of experience in oncology drug development, with a proven track record in clinical trial planning and execution.Deep understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH) related to clinical development.Strong written and verbal communication skills with the ability to present complex information clearly and persuasively.Proven ability to work autonomously and collaborate effectively within cross-functional teams.Experience in radiopharmaceutical or oncology-related clinical development is highly desirable.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.Summary of RoleLantheus, a leading innovator in radiopharmaceuticals, is seeking a Senior Medical Director, Oncology Drug Development to join our team. This pivotal individual contributor role will focus on clinical development planning, encompassing disease area strategy and asset development strategy for our expanding pipeline of oncology products. The ideal candidate will have extensive experience in clinical trial design, protocol writing, and execution specifically within the fields of oncology and radiopharmaceuticals.Key Responsibilities/Essential FunctionsClinical Development Strategy:
Develop and execute strategic clinical development plans for Lantheus's oncology drug candidates in alignment with overall company objectives and vision.Lead the formulation of comprehensive disease area strategies that focus on unmet clinical needs and optimize pathways for successful product development.
Asset Development:
Oversee asset development strategies, ensuring each project has a clear path from preclinical to post-market stages, while integrating learning and feedback into ongoing trials.Manage strategic interactions with cross-functional teams to align objectives related to regulatory strategy, clinical operations, and commercial considerations.
Protocol Development and Trial Management:Write and review clinical trial protocols and associated documents to ensure scientific rigor and regulatory compliance.Directly oversee the initiation and conduct of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.
Regulatory Submissions:Produce high-quality documentation for regulatory submissions, including INDs, CTAs, NDAs, and MAAs, to facilitate communication with regulatory authorities.Ensure that all submissions and interactions meet the rigorous standards expected by regulatory bodies and align with best practices.
Mentorship and Leadership:Provide strategic guidance and mentorship to junior team members, fostering an environment of professional growth and teamwork. Manage 1-2 direct reports if assigned.Ensure continuous professional development of team members through coaching and training on clinical trial management and regulatory processes.
Due Diligence and Business Development:Participate in due diligence reviews for potential business development opportunities, providing insights and recommendations based on clinical data and development strategies.Engage in discussions with potential partners or investors to present Lantheus's oncology product strategies and evidence of clinical efficacy.
Data Analysis and Reporting:Analyze clinical data and outcomes to inform therapeutic strategies and decision-making processes within the oncology portfolio.Prepare and present findings to executive leadership and external stakeholders, including participation in scientific conferences and publications.
Basic QualificationsM.D. in a relevant scientific field; board certification in Medical Oncology is highly preferred.A minimum of 5 years of experience in oncology drug development, with a proven track record in clinical trial planning and execution.Deep understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH) related to clinical development.Strong written and verbal communication skills with the ability to present complex information clearly and persuasively.Proven ability to work autonomously and collaborate effectively within cross-functional teams.Experience in radiopharmaceutical or oncology-related clinical development is highly desirable.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.