Lantheus
Director, Clinical Science - Hybrid
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 have helped physicians enhance patient care with our 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.
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 skills sets to be a part of a productive and inclusive team.
The Director, Clinical Science will be responsible for the design and interpretation of Lantheus clinical studies, including protocol development and oversight. This position has a key role in clinical development and supports progression of the investigational product from IND through registration, the position will operate in a cross-functional matrix environment and work with multiple functional groups. 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 relevance and accuracy of clinical science planning and guidance for a clinical study (e.g., study concepts/synopsis/study protocol development by translating the clinical development strategy into efficient clinical protocol and related documents
Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables, including but not limited to Clinical Protocols and amendments, Investigator Brochures, Study Manuals, Case Report Forms, Informed Consent Forms, Clinical Study Reports, Annual Reports, regulatory submissions, abstracts and publications
Responsible for the oversight of clinical study execution in close collaboration with Clinical Operations lead, internal and external stakeholders (data management, biostatistics, programming, drug safety and PV, medical imaging, medical writing, research and discovery)
Works with investigative sites and/or study teams to answer protocol related questions, resolve study conduct issues
Reviews clinical data listings, patient profiles and summaries to ensure data collection, data interpretation and data reporting proceeds in a manner consistent with the protocol, company processes/procedures and strategic objectives
Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
Works closely with internal and external stakeholders to accumulate scientific and clinical knowledge necessary to support clinical development execution of clinical protocols and data collection
Supports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions including but not limited to briefing documents, presentation materials, and IND/NDAs
Participates in review and management of safety reports and submissions
Participate in clinical and safety database reconciliation
Supports project team with conduct of clinical studies including clinical trials registration and results reporting, and in the monitoring and analysis of emerging clinical data and safety data trends. May be consulted in data management deliverables, clinical monitoring activities, interim analyses planning and Data Safety Monitoring Board or Steering Committee meetings as applicable
Interacts with internal and external stakeholders (Key Opinion Leaders, Medical Director, vendors, committees) in support of clinical trial objectives and deliverables, including investigator-sponsored trials
Leads preparation of advisory board meetings, and KOL interactions; leads development of clinical publications (eg. presentations at scientific meetings)
Works with external experts to develop abstracts, manuscripts and study design presentations
Works in a strategic and facilitative role by leveraging clinical development expertise in providing support to the Senior Medical Director Clinical Research
Serves as clinical representative on product development team
Leads drug development team across a complex, matrixed environment. Communicate a vision and strategy for this multidisciplinary team
Attends scientific meetings to remain abreast of clinical developments, interact with investigators, and advisors
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment.
Reports and takes initiative to correct safety & environmental hazards
Typical Minimum Skills and Experience and Education
Advanced Degree preferred (e.g. MS, PhD, or PharmD)
7 - 10 years of relevant experience in pharmaceutical industry in clinical development operations preferred
Oncology and neuroscience medical imaging and/or Radiopharmaceutical clinical development experience preferred
Clinical development experience across all phases of development (I - IV)
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
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
Routine overnight travel based on business need
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.
#LI-HYBRID
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)#J-18808-Ljbffr
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 have helped physicians enhance patient care with our 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.
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 skills sets to be a part of a productive and inclusive team.
The Director, Clinical Science will be responsible for the design and interpretation of Lantheus clinical studies, including protocol development and oversight. This position has a key role in clinical development and supports progression of the investigational product from IND through registration, the position will operate in a cross-functional matrix environment and work with multiple functional groups. 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 relevance and accuracy of clinical science planning and guidance for a clinical study (e.g., study concepts/synopsis/study protocol development by translating the clinical development strategy into efficient clinical protocol and related documents
Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables, including but not limited to Clinical Protocols and amendments, Investigator Brochures, Study Manuals, Case Report Forms, Informed Consent Forms, Clinical Study Reports, Annual Reports, regulatory submissions, abstracts and publications
Responsible for the oversight of clinical study execution in close collaboration with Clinical Operations lead, internal and external stakeholders (data management, biostatistics, programming, drug safety and PV, medical imaging, medical writing, research and discovery)
Works with investigative sites and/or study teams to answer protocol related questions, resolve study conduct issues
Reviews clinical data listings, patient profiles and summaries to ensure data collection, data interpretation and data reporting proceeds in a manner consistent with the protocol, company processes/procedures and strategic objectives
Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
Works closely with internal and external stakeholders to accumulate scientific and clinical knowledge necessary to support clinical development execution of clinical protocols and data collection
Supports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions including but not limited to briefing documents, presentation materials, and IND/NDAs
Participates in review and management of safety reports and submissions
Participate in clinical and safety database reconciliation
Supports project team with conduct of clinical studies including clinical trials registration and results reporting, and in the monitoring and analysis of emerging clinical data and safety data trends. May be consulted in data management deliverables, clinical monitoring activities, interim analyses planning and Data Safety Monitoring Board or Steering Committee meetings as applicable
Interacts with internal and external stakeholders (Key Opinion Leaders, Medical Director, vendors, committees) in support of clinical trial objectives and deliverables, including investigator-sponsored trials
Leads preparation of advisory board meetings, and KOL interactions; leads development of clinical publications (eg. presentations at scientific meetings)
Works with external experts to develop abstracts, manuscripts and study design presentations
Works in a strategic and facilitative role by leveraging clinical development expertise in providing support to the Senior Medical Director Clinical Research
Serves as clinical representative on product development team
Leads drug development team across a complex, matrixed environment. Communicate a vision and strategy for this multidisciplinary team
Attends scientific meetings to remain abreast of clinical developments, interact with investigators, and advisors
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment.
Reports and takes initiative to correct safety & environmental hazards
Typical Minimum Skills and Experience and Education
Advanced Degree preferred (e.g. MS, PhD, or PharmD)
7 - 10 years of relevant experience in pharmaceutical industry in clinical development operations preferred
Oncology and neuroscience medical imaging and/or Radiopharmaceutical clinical development experience preferred
Clinical development experience across all phases of development (I - IV)
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
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
Routine overnight travel based on business need
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.
#LI-HYBRID
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)#J-18808-Ljbffr