Lantheus
Senior Medical Director, Clinical Research - Neurology
Lantheus, Bedford, Massachusetts, us, 01730
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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. With revenues exceeding $1B in 2023, the company is in the process of developing a pipeline of radiopharmaceuticals for both imaging and therapy of cancers, Alzheimers, and other serious illnesses. 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.
The Senior Medical Director Clinical Research will report to the Head of Clinical Development and will oversee the assigned clinical development activities. They will be responsible for assisting with the advancement of specific neurology programs by devising clinical development strategies and by serving as a representative for Clinical Research on project-specific development teams.
The successful candidate will have wide-ranging responsibilities and the ability to work within a highly collaborative, dynamic, and interdisciplinary team.
Essential Functions
Responsible for the overall clinical development, taking into consideration the medical, scientific, regulatory, and commercial considerations for assigned pipeline products.
Leads a multi-disciplinary, matrix clinical development team with responsibility for development decisions, assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan.
Applies clinical/medical decision making to clinical development issues.
May serve as Clinical leader of individual therapeutic programs.
Develops Clinical Sub-Team strategy and deliverables in the context of the Global Program Team's Asset Strategy; works collaboratively to generate the Clinical Development Plan and Clinical Protocols and is accountable for the successful design and interpretation of clinical studies.
Responsible for performing and overseeing medical monitoring activities, assessing issues related to the study execution and individual patient`s safety and well-being, in partnership with the CRO responsible for trial delivery. Assesses overall safety information and risk-benefit information for studies and compounds in conjunction with Pharmacovigilance.
Responsible for high impact decisions: monitoring and interpreting data from ongoing internal and external trials, assessing the medical and scientific implications, and making recommendations that impact development. Makes final decisions regarding study conduct related to scientific integrity.
Manages, mentors, motivates, empowers, develops, and retains staff to support assigned activities. Conducts performance reviews and drives goal setting, and development planning. Coordinates, leads, and delivers periodic departmental training.
Contributes to and participates in the activities related to interactions with the regulatory authorities/agencies.
Establishes and maintains strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
Interacts and collaborates with Medical Affairs in relation to Investigator-Sponsored Trials and collaborative trials.
Responsible for evaluation of potential business development opportunities, conducts due diligence evaluations, and contributes to the development plans for potential alliances and/or in-licensing opportunities.
Serves as the clinical contact for ongoing alliance and collaboration projects, and interfaces with partners to achieve Lantheus's strategic goals while striving to maintain good working relationships between Lantheus and partner.
Attends scientific meetings to remain abreast of clinical developments, interacts with investigators, and advisors
Typical Minimum Skills, Experience and Education
MD degree (or equivalent non-US medical degree), (current active board certification or active medical license is not required; MD, PhD preferred)
5+ years of relevant experience in pharmaceutical industry in clinical development in neurology preferred
Clinical development experience across all phases of development (I - IV)
Previous experience successfully leading a clinical development/matrix team
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations, and vendors; experience in medical monitoring of neurology clinical trials and programs
Superior communication, strategic, interpersonal, and negotiating skills, effective leadership behavior, ability to drive decision making within a multi-disciplinary, matrix team, diplomacy, and positive influencing abilities
In depth knowledge of regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, clinical study reports and other study documents
Excellent verbal and written communication skills with ability to work across functions in multifunctional matrix environment
Other Requirements
Ability to drive or fly to various meetings or sites, including overnight trips; some international travel may be required.
This position is site-based and requires a presence on-site four days per week in Bedford, MA when not travelling.
Core Values:
The ideal candidate will embody Lantheus core values:
Let people be their best
Respect one another and act as one
Learn, adapt, and win
Know someone's health is in our hands
Own the solution and make it happen
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.
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Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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. With revenues exceeding $1B in 2023, the company is in the process of developing a pipeline of radiopharmaceuticals for both imaging and therapy of cancers, Alzheimers, and other serious illnesses. 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.
The Senior Medical Director Clinical Research will report to the Head of Clinical Development and will oversee the assigned clinical development activities. They will be responsible for assisting with the advancement of specific neurology programs by devising clinical development strategies and by serving as a representative for Clinical Research on project-specific development teams.
The successful candidate will have wide-ranging responsibilities and the ability to work within a highly collaborative, dynamic, and interdisciplinary team.
Essential Functions
Responsible for the overall clinical development, taking into consideration the medical, scientific, regulatory, and commercial considerations for assigned pipeline products.
Leads a multi-disciplinary, matrix clinical development team with responsibility for development decisions, assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan.
Applies clinical/medical decision making to clinical development issues.
May serve as Clinical leader of individual therapeutic programs.
Develops Clinical Sub-Team strategy and deliverables in the context of the Global Program Team's Asset Strategy; works collaboratively to generate the Clinical Development Plan and Clinical Protocols and is accountable for the successful design and interpretation of clinical studies.
Responsible for performing and overseeing medical monitoring activities, assessing issues related to the study execution and individual patient`s safety and well-being, in partnership with the CRO responsible for trial delivery. Assesses overall safety information and risk-benefit information for studies and compounds in conjunction with Pharmacovigilance.
Responsible for high impact decisions: monitoring and interpreting data from ongoing internal and external trials, assessing the medical and scientific implications, and making recommendations that impact development. Makes final decisions regarding study conduct related to scientific integrity.
Manages, mentors, motivates, empowers, develops, and retains staff to support assigned activities. Conducts performance reviews and drives goal setting, and development planning. Coordinates, leads, and delivers periodic departmental training.
Contributes to and participates in the activities related to interactions with the regulatory authorities/agencies.
Establishes and maintains strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
Interacts and collaborates with Medical Affairs in relation to Investigator-Sponsored Trials and collaborative trials.
Responsible for evaluation of potential business development opportunities, conducts due diligence evaluations, and contributes to the development plans for potential alliances and/or in-licensing opportunities.
Serves as the clinical contact for ongoing alliance and collaboration projects, and interfaces with partners to achieve Lantheus's strategic goals while striving to maintain good working relationships between Lantheus and partner.
Attends scientific meetings to remain abreast of clinical developments, interacts with investigators, and advisors
Typical Minimum Skills, Experience and Education
MD degree (or equivalent non-US medical degree), (current active board certification or active medical license is not required; MD, PhD preferred)
5+ years of relevant experience in pharmaceutical industry in clinical development in neurology preferred
Clinical development experience across all phases of development (I - IV)
Previous experience successfully leading a clinical development/matrix team
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations, and vendors; experience in medical monitoring of neurology clinical trials and programs
Superior communication, strategic, interpersonal, and negotiating skills, effective leadership behavior, ability to drive decision making within a multi-disciplinary, matrix team, diplomacy, and positive influencing abilities
In depth knowledge of regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, clinical study reports and other study documents
Excellent verbal and written communication skills with ability to work across functions in multifunctional matrix environment
Other Requirements
Ability to drive or fly to various meetings or sites, including overnight trips; some international travel may be required.
This position is site-based and requires a presence on-site four days per week in Bedford, MA when not travelling.
Core Values:
The ideal candidate will embody Lantheus core values:
Let people be their best
Respect one another and act as one
Learn, adapt, and win
Know someone's health is in our hands
Own the solution and make it happen
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.
#J-18808-Ljbffr