Director/ Senior Director Clinical Sciences
Moonlight Bio, Spokane, Washington, United States, 99254
Director/Senior Director, Clinical Science
About Moonlight Bio: Moonlight Bio is a Seattle-based, preclinical stage biotech company pioneering the development of cutting-edge cell therapies for the treatment of cancer. Our team is comprised of highly collaborative individuals who are passionate about designing innovative technologies and drug candidates with the potential to transform the lives of cancer patients. Engaging across the full landscape of drug development, Moonlight’s team members are pursuing opportunities in discovery research, component design and screening, preclinical modeling, process and analytical development, translational studies, and external partnerships necessary to enable and advance our core technologies.
Role: Reporting to Moonlight’s Chief Medical Officer, the Director/Senior Director of Clinical Science will be a highly visible, impactful position responsible for authoring and reviewing clinical study documents, contributing to the clinical study design and rationale, obtaining expert input, presenting data to internal and external audiences and supporting clinical study conduct. Further, the Director/Senior Director Clinical Science will be accountable for initiating and establishing procedures and standards in collaboration with the Clinical Operations team.
Responsibilities: Author and review clinical study-related documents including clinical protocols, Investigator brochure, Informed Consent forms, Case Report forms, and Progress Reports Plan and generate site training materials including training presentations or tools to help with safety assessments Author clinical components of regulatory briefing books and reports Collaborate with clinical lead on study design and rationale Support interactions to obtain expert clinical advice (SAB, KOLs) Support study conduct from start-up to data submission Participate in site selection and training, and triage/respond to site questions Conduct study and individual patient tracking Review, clean, summarize, and prepare clinical and translational data for presentations Present clinical data to internal and external audiences (e.g., investigator meetings, safety review committees) Provide input to inform regulatory decisions Author/review clinical content for publications and regulatory submissions Collaborate with clinical lead, clinical operations, quality, regulatory affairs, CROs, etc. to develop and review SOPs, Independent Review Charters, Procedures, Protocols, Clinical Study Reports, INDs, BLAs, and other clinical, regulatory/safety documents Collaborate with clinical operations and clinical lead on staffing and budgeting
We are looking for candidates who possess the following qualifications: Experience in early clinical development, cell therapy, and oncology (ideally in solid tumors) Excellent verbal, written, communication and interpersonal skills Prior leadership experience (including managing people) Detail-oriented with strong organizational skills Strong ability to work collaboratively in teams Critical thinking, creative problem-solving and initiative-taking skills as well as adaptability in a fast-paced environment Bachelor of Science preferred Pharm D or PhD degree in life sciences 12+ years of relevant industry experience
Location: This role will be located in Seattle, Washington and requires the ability to travel domestically and internationally (25%)
What you should know: ·
The base pay range for this position at commencement of employment is expected to be between $180,000 to 230,000. ·
The base pay offered may vary depending on a variety of individualized factors, including the relevance, and years, of the applicant’s experience, job-related knowledge, skill set, certifications, qualifications, and/or professional licenses held, and market location. ·
Full time employees (and their eligible dependents) will be eligible for employee benefits including PTO, medical, dental, and vision plans from the first day of employment. Further, Moonlight supports its team members in pursuing certifications, conferences, and training relevant to their roles.
At Moonlight Bio, we are committed to growing and nurturing a diverse team, providing equal employment opportunities to all employees and applicants without regard to characteristics and statuses protected under applicable federal, state, and local laws. Applicants must be authorized to work in the United States. Moonlight Bio will not sponsor applicants for work visas.
Join us at Moonlight Bio and contribute to groundbreaking research that has the potential to create innovative and powerful new cancer therapies! With our collaborative, team-centric R&D approach, and our dedication to professional development, you’ll have the opportunity to make a meaningful impact on patients’ lives while advancing your career in the dynamic field of cell therapy.
Please apply directly within LinkedIn or submit your resume/CV and cover letter to
careers@moonlightbio.us
About Moonlight Bio: Moonlight Bio is a Seattle-based, preclinical stage biotech company pioneering the development of cutting-edge cell therapies for the treatment of cancer. Our team is comprised of highly collaborative individuals who are passionate about designing innovative technologies and drug candidates with the potential to transform the lives of cancer patients. Engaging across the full landscape of drug development, Moonlight’s team members are pursuing opportunities in discovery research, component design and screening, preclinical modeling, process and analytical development, translational studies, and external partnerships necessary to enable and advance our core technologies.
Role: Reporting to Moonlight’s Chief Medical Officer, the Director/Senior Director of Clinical Science will be a highly visible, impactful position responsible for authoring and reviewing clinical study documents, contributing to the clinical study design and rationale, obtaining expert input, presenting data to internal and external audiences and supporting clinical study conduct. Further, the Director/Senior Director Clinical Science will be accountable for initiating and establishing procedures and standards in collaboration with the Clinical Operations team.
Responsibilities: Author and review clinical study-related documents including clinical protocols, Investigator brochure, Informed Consent forms, Case Report forms, and Progress Reports Plan and generate site training materials including training presentations or tools to help with safety assessments Author clinical components of regulatory briefing books and reports Collaborate with clinical lead on study design and rationale Support interactions to obtain expert clinical advice (SAB, KOLs) Support study conduct from start-up to data submission Participate in site selection and training, and triage/respond to site questions Conduct study and individual patient tracking Review, clean, summarize, and prepare clinical and translational data for presentations Present clinical data to internal and external audiences (e.g., investigator meetings, safety review committees) Provide input to inform regulatory decisions Author/review clinical content for publications and regulatory submissions Collaborate with clinical lead, clinical operations, quality, regulatory affairs, CROs, etc. to develop and review SOPs, Independent Review Charters, Procedures, Protocols, Clinical Study Reports, INDs, BLAs, and other clinical, regulatory/safety documents Collaborate with clinical operations and clinical lead on staffing and budgeting
We are looking for candidates who possess the following qualifications: Experience in early clinical development, cell therapy, and oncology (ideally in solid tumors) Excellent verbal, written, communication and interpersonal skills Prior leadership experience (including managing people) Detail-oriented with strong organizational skills Strong ability to work collaboratively in teams Critical thinking, creative problem-solving and initiative-taking skills as well as adaptability in a fast-paced environment Bachelor of Science preferred Pharm D or PhD degree in life sciences 12+ years of relevant industry experience
Location: This role will be located in Seattle, Washington and requires the ability to travel domestically and internationally (25%)
What you should know: ·
The base pay range for this position at commencement of employment is expected to be between $180,000 to 230,000. ·
The base pay offered may vary depending on a variety of individualized factors, including the relevance, and years, of the applicant’s experience, job-related knowledge, skill set, certifications, qualifications, and/or professional licenses held, and market location. ·
Full time employees (and their eligible dependents) will be eligible for employee benefits including PTO, medical, dental, and vision plans from the first day of employment. Further, Moonlight supports its team members in pursuing certifications, conferences, and training relevant to their roles.
At Moonlight Bio, we are committed to growing and nurturing a diverse team, providing equal employment opportunities to all employees and applicants without regard to characteristics and statuses protected under applicable federal, state, and local laws. Applicants must be authorized to work in the United States. Moonlight Bio will not sponsor applicants for work visas.
Join us at Moonlight Bio and contribute to groundbreaking research that has the potential to create innovative and powerful new cancer therapies! With our collaborative, team-centric R&D approach, and our dedication to professional development, you’ll have the opportunity to make a meaningful impact on patients’ lives while advancing your career in the dynamic field of cell therapy.
Please apply directly within LinkedIn or submit your resume/CV and cover letter to
careers@moonlightbio.us