Senior Principal Scientific Advisor (REMOTE)
for each section heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive info. Let's extract content.
First paragraph: "For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about." This is generic intro; could be part of About the role? Might be considered About the role. We'll include in About the role.
Then "Job Overview We are seeking an experienced nonclinical drug development professional to serve as a Senior Principal Scientific Advisor within our Safety Assessment business units. The Scientific Advisory Services team is seeking an experienced professional to provide strategic scientific guidance for the advancement of innovative medicines from discovery through first-in-human (FIH) studies and clinical development. This position provides opportunities for independent scientific guidance and leadership within multidisciplinary project teams and across functional areas. The role focuses on developing and implementing nonclinical pharmacology and toxicology strategies that support key development milestones, regulatory interactions, and domestic and global registration objectives. Responsibilities span a broad range of advanced therapeutic modalities, including cell and gene therapies, oligonucleotides, RNA-based therapeutics, antibody-drug conjugates (ADCs), bispecific antibodies, and other advanced and emerging platforms. Expertise in designing and executing integrated nonclinical development programs encompassing pharmacology, toxicology, pharmacokinetics, biodistribution, immunogenicity, and translational sciences is essential. Success in this role requires a strong understanding of global regulatory expectations, sound scientific judgment, and the ability to deliver innovative, risk-based strategies. This individual will work closely with current and potential clients and internal Charles River functional groups. The person may act as the scientific leader within cross-functional teams to integrate discovery and safety programs. When appropriate, the individual may perform gap analyses, support due diligence procedures, and perform scientific review of discovery and/or safety assessment data or reports. This role provides for recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in determining the appropriate discovery and nonclinical safety assessment strategy for complex and novel products. There will be opportunities to support department leadership regarding strategy and recruitment. More broadly, one will work closely with Business Development, Client Services, Account Management, Marketing, and Operations by ensuring that clients’ business and scientific needs are understood and efficiently addressed. In addition to providing scientific and regulatory support in client interactions, the individual will have the ability to an expanded breadth of experience in covering multiple drug modalities and be able to contribute solutions to complex scientific and regulatory issues when situations occur during the conduct of a drug development program. They will be able to lend support to multiple divisions of CRL and assume leadership roles in multidisciplinary teams when required. Within Charles River, the individual will be able to provide pivotal leadership and guidance to internal working groups, projects, and/or marketing activities when requested. This position will mainly support potential clients generally located in the Eastern through Pacific Time Zones."
That's a lot of responsibilities and overview. We can split: About the role (overview) and Responsibilities (list). The responsibilities list includes many items; we can extract bullet points.
Responsibilities bullet points:
- Provide strategic scientific guidance for advancement of innovative medicines from discovery through FIH studies and clinical development.
- Develop and implement nonclinical pharmacology and toxicology strategies supporting key development milestones, regulatory interactions, domestic/global registration objectives.
- Work across advanced therapeutic modalities: cell and gene therapies, oligonucleotides, RNA-based therapeutics, ADCs, bispecific antibodies, other advanced/emerging platforms.
- Design and execute integrated nonclinical development programs encompassing pharmacology, toxicology, pharmacokinetics, biodistribution, immunogenicity, translational sciences.
- Apply strong understanding of global regulatory expectations, sound scientific judgment, deliver innovative risk-based strategies.
- Work closely with current/potential clients and internal functional groups.
- Act as scientific leader within cross-functional teams to integrate discovery and safety programs.
- Perform gap analyses, support due diligence, scientific review of discovery/safety assessment data/reports.
- Serve as subject matter expert recognized company-wide in therapeutic area(s) or class(es).
- Provide intellectual input on discovery and nonclinical safety assessment strategy for complex/novel products.
- Support department leadership regarding strategy and recruitment.
- Work closely with Business Development, Client Services, Account Management, Marketing, Operations to ensure client needs understood and addressed.
- Provide scientific/regulatory support in client interactions; contribute solutions to complex scientific/regulatory issues during drug development.
- Lend support to multiple divisions of CRL, assume leadership roles in multidisciplinary teams when required.
- Provide pivotal leadership and guidance to internal working groups, projects, marketing activities when requested.
- Support potential clients located Eastern through Pacific Time Zones.
We can condense but must preserve all substantive info; we can keep as bullet points summarizing each distinct responsibility.
Job Qualifications section: "Job Qualifications The following are minimum requirements related to the Senior Principal Scientific Advisor position. Education: master’s degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.).Experience: Minimum 20 years’ experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 12 years nonclinical drug development experience. Must have direct experience in regulated toxicology and drug development. Prior direct experience in interacting with regulatory agencies is preferable. Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful. Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred.Other: Applied understanding of regulatory requirements for the conduct of nonclinical safety assessment studies including Good Laboratory Practices (GLPs). Deep understanding of relevant regulatory guidance documents is essential. Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and standard laboratory calculations."
We can split into Requirements (education, experience) and Skills (certifications, software proficiency, leadership). But we have sections: Requirements, Qualifications, Skills. The instruction says use headings for those categories if content exists. We have qualifications (education/experience) and skills (certifications, software, leadership). We could put education/experience under Requirements, and certifications/software/leadership under Skills. Or we could combine under Qualifications. But we need to follow instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have Requirements, Qualifications, Skills. However we must not create thin sections; prefer few substantive sections over many thin ones. So we might combine Requirements and Qualifications into one section? But they are distinct headings; we could have Requirements (education/experience) and Qualifications (certifications, leadership, software). That seems reasonable.
Let's extract:
Requirements:
- Education: master’s degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.).
- Experience: Minimum 20 years’ experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 12 years nonclinical drug development experience.
- Must have direct experience in regulated toxicology and drug development.
- Prior direct experience in interacting with regulatory agencies is preferable.
- Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful.
Qualifications (or Skills):
- Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred.
- Applied understanding of regulatory requirements for conduct of nonclinical safety assessment studies including GLPs.
- Deep understanding of relevant regulatory guidance documents is essential.
- Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development.
- Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and standard laboratory calculations.
We could also include "Other:" as part of Qualifications.
Benefits: list: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, work life balance flexibility.
Pay: hiring range $220,000/yr - $240,000/yr. Note about variation.
We should not include boilerplate like EEO, accommodation request, etc. Also remove the Job ID at end "235385". Also remove the "About Safety Assessment" and "About Charles River" sections? Those are substantive but maybe not required headings; they could be part of About the role? The instruction says include a section ONLY when posting has real specific content for it. The "About Safety Assessment" and "About Charles River" are descriptive of the company; could be considered part of About the role? But we already have About the role covering job overview. However we might include them as part of About the role to preserve all substantive info. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." So we need to keep that info somewhere. We could add a subsection under About the role (maybe as paragraphs) describing Charles River and Safety Assessment. That seems appropriate.
Thus About the role will include the introductory paragraphs plus the "About Safety Assessment" and "About Charles River" paragraphs.
Let's extract those:
About Safety Assessment: "Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities."
About Charles River: "Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies,
for prose. We need to preserve all substantive info. Let's extract content. First paragraph: "For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about." This is generic intro; could be part of About the role? Might be considered About the role. We'll include in About the role. Then "Job Overview We are seeking an experienced nonclinical drug development professional to serve as a Senior Principal Scientific Advisor within our Safety Assessment business units. The Scientific Advisory Services team is seeking an experienced professional to provide strategic scientific guidance for the advancement of innovative medicines from discovery through first-in-human (FIH) studies and clinical development. This position provides opportunities for independent scientific guidance and leadership within multidisciplinary project teams and across functional areas. The role focuses on developing and implementing nonclinical pharmacology and toxicology strategies that support key development milestones, regulatory interactions, and domestic and global registration objectives. Responsibilities span a broad range of advanced therapeutic modalities, including cell and gene therapies, oligonucleotides, RNA-based therapeutics, antibody-drug conjugates (ADCs), bispecific antibodies, and other advanced and emerging platforms. Expertise in designing and executing integrated nonclinical development programs encompassing pharmacology, toxicology, pharmacokinetics, biodistribution, immunogenicity, and translational sciences is essential. Success in this role requires a strong understanding of global regulatory expectations, sound scientific judgment, and the ability to deliver innovative, risk-based strategies. This individual will work closely with current and potential clients and internal Charles River functional groups. The person may act as the scientific leader within cross-functional teams to integrate discovery and safety programs. When appropriate, the individual may perform gap analyses, support due diligence procedures, and perform scientific review of discovery and/or safety assessment data or reports. This role provides for recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in determining the appropriate discovery and nonclinical safety assessment strategy for complex and novel products. There will be opportunities to support department leadership regarding strategy and recruitment. More broadly, one will work closely with Business Development, Client Services, Account Management, Marketing, and Operations by ensuring that clients’ business and scientific needs are understood and efficiently addressed. In addition to providing scientific and regulatory support in client interactions, the individual will have the ability to an expanded breadth of experience in covering multiple drug modalities and be able to contribute solutions to complex scientific and regulatory issues when situations occur during the conduct of a drug development program. They will be able to lend support to multiple divisions of CRL and assume leadership roles in multidisciplinary teams when required. Within Charles River, the individual will be able to provide pivotal leadership and guidance to internal working groups, projects, and/or marketing activities when requested. This position will mainly support potential clients generally located in the Eastern through Pacific Time Zones." That's a lot of responsibilities and overview. We can split: About the role (overview) and Responsibilities (list). The responsibilities list includes many items; we can extract bullet points. Responsibilities bullet points: - Provide strategic scientific guidance for advancement of innovative medicines from discovery through FIH studies and clinical development. - Develop and implement nonclinical pharmacology and toxicology strategies supporting key development milestones, regulatory interactions, domestic/global registration objectives. - Work across advanced therapeutic modalities: cell and gene therapies, oligonucleotides, RNA-based therapeutics, ADCs, bispecific antibodies, other advanced/emerging platforms. - Design and execute integrated nonclinical development programs encompassing pharmacology, toxicology, pharmacokinetics, biodistribution, immunogenicity, translational sciences. - Apply strong understanding of global regulatory expectations, sound scientific judgment, deliver innovative risk-based strategies. - Work closely with current/potential clients and internal functional groups. - Act as scientific leader within cross-functional teams to integrate discovery and safety programs. - Perform gap analyses, support due diligence, scientific review of discovery/safety assessment data/reports. - Serve as subject matter expert recognized company-wide in therapeutic area(s) or class(es). - Provide intellectual input on discovery and nonclinical safety assessment strategy for complex/novel products. - Support department leadership regarding strategy and recruitment. - Work closely with Business Development, Client Services, Account Management, Marketing, Operations to ensure client needs understood and addressed. - Provide scientific/regulatory support in client interactions; contribute solutions to complex scientific/regulatory issues during drug development. - Lend support to multiple divisions of CRL, assume leadership roles in multidisciplinary teams when required. - Provide pivotal leadership and guidance to internal working groups, projects, marketing activities when requested. - Support potential clients located Eastern through Pacific Time Zones. We can condense but must preserve all substantive info; we can keep as bullet points summarizing each distinct responsibility. Job Qualifications section: "Job Qualifications The following are minimum requirements related to the Senior Principal Scientific Advisor position. Education: master’s degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.).Experience: Minimum 20 years’ experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 12 years nonclinical drug development experience. Must have direct experience in regulated toxicology and drug development. Prior direct experience in interacting with regulatory agencies is preferable. Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful. Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred.Other: Applied understanding of regulatory requirements for the conduct of nonclinical safety assessment studies including Good Laboratory Practices (GLPs). Deep understanding of relevant regulatory guidance documents is essential. Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and standard laboratory calculations." We can split into Requirements (education, experience) and Skills (certifications, software proficiency, leadership). But we have sections: Requirements, Qualifications, Skills. The instruction says use headings for those categories if content exists. We have qualifications (education/experience) and skills (certifications, software, leadership). We could put education/experience under Requirements, and certifications/software/leadership under Skills. Or we could combine under Qualifications. But we need to follow instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have Requirements, Qualifications, Skills. However we must not create thin sections; prefer few substantive sections over many thin ones. So we might combine Requirements and Qualifications into one section? But they are distinct headings; we could have Requirements (education/experience) and Qualifications (certifications, leadership, software). That seems reasonable. Let's extract: Requirements: - Education: master’s degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.). - Experience: Minimum 20 years’ experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 12 years nonclinical drug development experience. - Must have direct experience in regulated toxicology and drug development. - Prior direct experience in interacting with regulatory agencies is preferable. - Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful. Qualifications (or Skills): - Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred. - Applied understanding of regulatory requirements for conduct of nonclinical safety assessment studies including GLPs. - Deep understanding of relevant regulatory guidance documents is essential. - Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development. - Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and standard laboratory calculations. We could also include "Other:" as part of Qualifications. Benefits: list: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, work life balance flexibility. Pay: hiring range $220,000/yr - $240,000/yr. Note about variation. We should not include boilerplate like EEO, accommodation request, etc. Also remove the Job ID at end "235385". Also remove the "About Safety Assessment" and "About Charles River" sections? Those are substantive but maybe not required headings; they could be part of About the role? The instruction says include a section ONLY when posting has real specific content for it. The "About Safety Assessment" and "About Charles River" are descriptive of the company; could be considered part of About the role? But we already have About the role covering job overview. However we might include them as part of About the role to preserve all substantive info. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." So we need to keep that info somewhere. We could add a subsection under About the role (maybe as paragraphs) describing Charles River and Safety Assessment. That seems appropriate. Thus About the role will include the introductory paragraphs plus the "About Safety Assessment" and "About Charles River" paragraphs. Let's extract those: About Safety Assessment: "Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities." About Charles River: "Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies,