Description

Premier Consulting, a division of Premier Research, is seeking a Toxicologist. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

What You’ll Be Doing: 

• Independently creates and reviews documents in support of client work products and regulatory submissions, including Feasibility Reports; Go-no-Go Reports; Briefing Packages; Nonclinical Study Synopses/Protocols; Research Papers; Regulatory Documents for INDs, BLAs, NDAs, ANDAs, and other regulatory submissions; Abstracts; Posters; Manuscripts.  
• In coordination with other Toxicologists and project scientists, analyzes Sponsor’s drug and clinical indication, performs gap analysis on their existing nonclinical data, and develops nonclinical programs to support clinical development, including appropriate pharmacology, pharmacokinetic, and toxicology studies. 
• Nonclinical study design contracting, monitoring (on-site and off-site), and reporting. Acting as a liaison between the Sponsor, CRO, and Camargo to ensure nonclinical studies go as planned, meet timelines, and are conducted according to the approved protocol. 
• Performs thorough independent background research through all pertinent search engines for further in-depth research efforts (i.e. literature searches, FDA regulations, and guidelines) related to medical and regulatory documents, filings, and/or submissions. Ensures that documents appropriately evaluate and present data and methodology, accurately reflecting the information provided in the public domain (i.e., scientific articles, Summary Basis of Approval, Freedom of Information [FOI’s], etc.).   Navigate and obtain information for projects from all available resources (Internet, PDR, FOI, FDA, library).  
• Produces scientifically accurate documents that are written in a timely manner consistent with applicable regulations and guidance documents, client strategic intent, and conform to Camargo’s standards for accuracy, readability, and quality (e.g., conformance with internal SOPs, style guides, and review processes); can effectively summarize published literature for insertion into work products. 
• Participates in multidisciplinary project teams as an active participant and nonclinical lead; collaborating on the preparation of project plans, completing assigned tasks, and reporting progress; and strives to produce high-quality deliverables (eg, reports, study outcomes, CTD nonclinical sections). 

What We Are Searching For:  

• ​​Knowledge and skills at a level normally acquired through the completion of a Master’s or PhD in Toxicology or related field with at least 5 or 8 years of industry experience required, respectively.  
• ​Study Director experience at a Contract Research Organization is highly desired. 
• ​Knowledge in 505(b)(2) programs and regulatory requirements for biologics, gene therapy, and/or vaccines is highly desired 
• ​Demonstrated knowledge of the research process and direct research experience.    
• ​Define problems, collect data, establish facts and draw valid conclusions. 
• ​​Ability to travel 10-15%, including inter-office travel. 

Why Choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#REMOTE
#LI-SC1​​

Description

Premier Consulting, a division of Premier Research, is seeking a Toxicologist. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

What You’ll Be Doing: 

• Independently creates and reviews documents in support of client work products and regulatory submissions, including Feasibility Reports; Go-no-Go Reports; Briefing Packages; Nonclinical Study Synopses/Protocols; Research Papers; Regulatory Documents for INDs, BLAs, NDAs, ANDAs, and other regulatory submissions; Abstracts; Posters; Manuscripts.  
• In coordination with other Toxicologists and project scientists, analyzes Sponsor’s drug and clinical indication, performs gap analysis on their existing nonclinical data, and develops nonclinical programs to support clinical development, including appropriate pharmacology, pharmacokinetic, and toxicology studies. 
• Nonclinical study design contracting, monitoring (on-site and off-site), and reporting. Acting as a liaison between the Sponsor, CRO, and Camargo to ensure nonclinical studies go as planned, meet timelines, and are conducted according to the approved protocol. 
• Performs thorough independent background research through all pertinent search engines for further in-depth research efforts (i.e. literature searches, FDA regulations, and guidelines) related to medical and regulatory documents, filings, and/or submissions. Ensures that documents appropriately evaluate and present data and methodology, accurately reflecting the information provided in the public domain (i.e., scientific articles, Summary Basis of Approval, Freedom of Information [FOI’s], etc.).   Navigate and obtain information for projects from all available resources (Internet, PDR, FOI, FDA, library).  
• Produces scientifically accurate documents that are written in a timely manner consistent with applicable regulations and guidance documents, client strategic intent, and conform to Camargo’s standards for accuracy, readability, and quality (e.g., conformance with internal SOPs, style guides, and review processes); can effectively summarize published literature for insertion into work products. 
• Participates in multidisciplinary project teams as an active participant and nonclinical lead; collaborating on the preparation of project plans, completing assigned tasks, and reporting progress; and strives to produce high-quality deliverables (eg, reports, study outcomes, CTD nonclinical sections). 

What We Are Searching For:  

• ​​Knowledge and skills at a level normally acquired through the completion of a Master’s or PhD in Toxicology or related field with at least 5 or 8 years of industry experience required, respectively.  
• ​Study Director experience at a Contract Research Organization is highly desired. 
• ​Knowledge in 505(b)(2) programs and regulatory requirements for biologics, gene therapy, and/or vaccines is highly desired 
• ​Demonstrated knowledge of the research process and direct research experience.    
• ​Define problems, collect data, establish facts and draw valid conclusions. 
• ​​Ability to travel 10-15%, including inter-office travel. 

Why Choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#REMOTE
#LI-SC1​​

Description

Heifer International is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

FUNCTION
The Associate Director for Business Development in the Americas plays an integral part in funding opportunities trends analytics, assessment of best funding opportunities, developing proposals and supporting business development for Heifer’s mission in the Americas, under the leadership and guidance of the Sr. Director for New Business Development. The Associate Director for BD will be guided by the Sr. Director’s strategic leadership and will work jointly to build pipelines for partnerships with institutional donors, the private sector, and governmental institutions. 

The Associate Director of Business Development will understand the business agenda, interest, concerns, and priorities of potential donors; be able to identify, cultivate, and develop relationships that will result in new opportunities for the organization. The role will contribute to the execution of the revenue strategy for short, medium and long-term resource mobilization, partnering with business development staff across the organization. 

The Associate Director will focus on proposal development management, and writing; donor engagement; and market research and business intelligence/analysis.  The position will also support certain operations functions in coordination with country-based staff working on business development.  

In close coordination with the Sr. BD Director, the role will support donor engagement by developing relationships with key donors and stakeholders to cultivate funding opportunities and position Heifer International for greater impact and revenue generation.

ESSENTIAL CHARACTER TRAITS:  
a. Business acumen and organizational savvy to drive results in complex environments and adaptable learning is essential. 
b. Ability to apply a strategic mindset and be politically astute. 
c. Ability to collaborate, communicate effectively, instill trust, and demonstrate self-awareness. 
d. Ability to build effective and empowered teams, and to be resourceful. 
e. Ability to provide effective leadership and drive team spirit. 
f. Plans and aligns, optimizes work processes, and ensures accountability. 
g. Ability to have effective decision-making. 
h. Strong organizational skills. 

Primary Duties and Responsibilities

I. Funding sources information management: LOE: 25%
• Undertake funding market research to gather and analyze information about funding opportunities, donors, industry trends, and other business development topics.
• Support and contribute to business intelligence research to help position strategic planning; research and analysis of funding trends among key donors and clients.
• Serve as a Capture Manager using proven industry practices and tools and provide support to capture efforts as needed. Lead or support the crafting and execution of opportunity pursuit strategy and proposal approach.
• Liaise Country teams with US-based new business development support units and partners.
• Keep updated track record of funding relationships mainly in Americas to propose the best fit with potential partnerships (consortia) for collaboration and funding access.  

II. Business Development and Proposal Development/Design Management LOE: 30% 
• Contribute to proactive and responsive business development support for the Americas Region.
• Lead the development of a proposal pipeline for Americas Area in close coordination with Country teams. 
• Work closely with the team to successfully manage proposal efforts and resources. 
• Manage proposal processes and serve as the information hub for proposal teams, liaising across Heifer divisions and with partner organizations. 
• Troubleshoot common problems and propose solutions, elevating complex problems to senior managers. 
• Ensures adherence to assignments, schedules, adherence to requirements, and standard Heifer operating procedures.
• Develop and maintain a comprehensive understanding of the portfolio program goals and objectives, and awareness of the work of technical portfolios across the organization.
• Support or oversee cost proposal development.

III. Business Development Writing and Editing LOE 20%
•Conceptualization, management, and participation in capture trips that lead to quality opportunity pursuit.
• Serve as proposal writer or write proposal sections, as required. Draft expressions of interest, corporate capability statements, personnel and management sections, past performance references, biographical sketches, and other proposal components
• Coordinate and manage information gathering, section drafting, and related tasks when undertaken by additional staff or third parties.
• Review and edit submissions from third parties to meet content and quality standards.

IV. Proposal Quality and Compliance LOE 15%
• Lead and participate in proposal compliance reviews including color team reviews, the use of proposal development tools, etc.

V. Training LOE 10%
• Serves as a mentor and coach to Heifer staff introducing them to business development processes and activities. 

Minimum Requirements: 
• Bachelors in a relevant subject (e.g. international relations, economics, etc.) with at least five (5) years of related professional experience.
• Minimum of five (5) years of experience in business/proposal development with major bilateral and multilateral donors.
• Demonstrated understanding of and interest in international development.
• A strong track record of proposal management and development, strategic outreach, and engagement.
• Rigorous attention to detail.
• Strong teamwork skills, competitive instincts, and proven experience working independently.
• Excellent written and verbal communication skills. Experience leading or supporting proposal writing.
• Demonstrated ability to multi-task. 
• Knowledge of industry best practices in business development.
• Ability to support, cultivate, and anticipate future business opportunities. Experience in networking for intelligence gathering for partnerships that will generate revenue.
• Ability to thrive in a fast-paced organization; enthusiastic, entrepreneurial, “can do” attitude.• High energy, collaborative, leader with outstanding interpersonal skills.
• Capable of nurturing individuals, at the same time as being an energetic team builder across departments and a global organization.• Willingness and ability to travel domestically and abroad.
• Ability to support Heifer’s mission, Cornerstones Model, and values.
• Proficiency in Spanish / French and fluency in English.

Preferred Requirements: 
Masters degree on relevant field.  

Most Critical Proficiencies: 
a. Advanced leadership and management skills with the ability to oversee multiple tasks, prioritize and delegate. 
b. Skilled in leading and managing high-performing teams. 
c. Proven record of aligning diverse, multi-level teams with the mission and vision. 
d. Capacity to work under pressure. 
e. Strong analytical and reporting skills along with strong financial acumen. 
f. Strong people management skills with demonstrated interest and ability to give feedback, develop, motivate and lead a diverse team. 
g. Both politically and culturally sensitive.  

Essential Job Functions and Physical Demands: 
a. Ability to travel up to 15% of time. 
b. Constant face-to-face, telephone and electronic communication with colleagues and the general public. 
c. Constant sitting, standing, and walking with occasional bending and lifting; may work at a computer for extended periods of time. 
d. Ability to work with sensitive information and maintain confidentiality.

Salary Information: 
The expected base salary range for this position is $120k - $155k USD annually. Placement within the range will be based on the experience and competency level of the candidate. 

What we offer:  
Heifer International offers a variety of benefits for U.S. based employees working 30 or more hours per week.
Health and wellness benefits including Flexible Spending Account and/or Health Saving Account 
Employee assistance program 
403(b) retirement plan (match 1% employee to 2% employer up to a maximum of 4% match +3% employer discretionary contribution regardless of employee contribution) 
22 vacation days in addition to 12 statutory and discretionary holidays, and 10 sick days per year 
Employer-paid life insurance and accidental death & dismemberment (AD&D)  
Professional development and annual merit increase opportunities 
Optional critical illness insurance, legal assistance plan and pet protection 
And more! 

Heifer International is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with some form of disability.