CURRENT JOB OPPORTUNITIES
Associate Director / Director / Senior Director of Clinical Pharmacology - Remote
We are seeking a qualified professional for the Associate Director/Director/Senior Director of Clinical Pharmacology. The candidate will report to the Vice President, Clinical Pharmacology & DMPK. The candidate will be responsible for the Clinical Pharmacology plan for assigned projects and serve as the Clinical Pharmacology lead in project and study teams. The candidate will collaborate with cross-functional teams to identify and mitigate challenges related to all aspects of clinical pharmacology.
Responsibilities:
- Draft and update Clinical Pharmacology plans and design Clinical Pharmacology studies.
- Apply model-informed drug development for dosage optimization at all stages of clinical development based on nonclinical and clinical data.
- Contribute to key clinical and regulatory documents (e.g., study protocols, study reports, IBs, DSURs/PSURs, INDs, NDAs, MAAs) and address Clinical Pharmacology-related regulatory questions.
- Partner with cross-function teams to advance projects.
- Oversee outsourced Clinical Pharmacology related work.
- Support data analysis by preparing data in various forms (e.g. figures or data tables).
- Other duties as assigned.
Requirements:
- Ph.D. or Pharma D. degree in pharmacokinetics, clinical pharmacology, or relevant biological sciences.
- Minimum 5 years of experience of pharmacokinetics and clinical pharmacology in the small molecule drug development.
- Well informed with the current FDA, EMA, ICH guidances on DMPK and Clinical Pharmacology.
- Extensive experience in designing clinical PK protocols, performing PK/PD analysis, and interpreting the impact of study results on clinical programs.
- Hands-on experience in quantitative modeling methods (e.g., population PK, exposure-response analysis, PBPK) and modeling tools (e.g., NONMEM, WinNonlin, R, etc.).
- At least 5 years of working experience in oncology and/or anti-inflammation drug development.
- Hands-on experience in NDA/MAA filing and regulatory interactions are highly preferred, but not required.
- Capability to mentor junior scientists and provide cross-functional education.
- Good network with scientific leaders and CROs.
- Experience with Microsoft Office Suite, including basic Excel skills.
- Ability to juggle multiple activities and work under pressure.
- Results-driven and oriented individual with strong attention to detail to deliver high-quality work product.
- Ability to organize competing priorities logically.
- Ability to demonstrate strong customer focus and collaboration, and problem-solving skills.
- Ability to handle a high volume of work.
- Experience working for a biotech or pharmaceutical company preferred.
- Willingness to expand the range of job responsibilities as needed.
Position Type/Expected Hours of Work:
This is a full-time position (40 hours/week). Position is fully remote with minimal travel requirement.
Competencies:
- Communicate in English, both orally and in writing (communication skills).
- Organize, analyze, and interpret data (critical thinking).
- Exhibit attention to detail (critical thinking).
- Plan effectively (project management; planning and organizing).
- Demonstrate creativity and resourcefulness (problem solving).
- Understand and follow directions (technical capacity).
- Remain flexible and reliable (teamwork and negotiation).
- Apply effective time management skills (time management).
- Exercise good judgment and maintain strictest confidentiality (ethical conduct).
- Follow and apply appropriate laws, regulations, policies, and procedures (ethical conduct).
Additional Information:
NiKang currently anticipates that the annual base salary range for this position is estimated to be from $150,000 to $250,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401 (k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.
Associate Director/Director / Senior Director of Clinical Development (MD) - Remote
We are seeking a qualified professional for the Associate Director/Director/Senior Director of Clinical Development. The candidate will report to the VP of clinical development with responsibility for leading the clinical development of novel small molecule targeted therapies for the treatment of cancer or other serious diseases. This candidate works collaboratively with internal multi-disciplinary teams and external stakeholders to provide high-quality scientific and clinical expertise to guide the strategy and execution of the clinical development plan.
Responsibilities:
- Serve as clinical subject matter expert on internal teams, and partner with investigators, opinion leaders in the design and execution of clinical studies for selected drug candidates and/or combinations.
- Contribute to design, analysis, interpretation, and reporting of scientific content of protocols, investigator brochures, clinical study reports, regulatory submissions and responses, and other program documents.
- Serve as study medical monitor and provide ongoing oversight for conduct of clinical trials with responsibilities to include oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating safety and efficacy data.
- Along with clinical operations, work closely with the CRO and study sites to ensure oversight of enrollment and overall timelines for key deliverables.
- Contribute to the development and execution of clinical development plans, develop contingency plans, provide technical and strategic advice to internal project teams.
- Contribute as a clinical subject matter expert to research and nonclinical studies that may inform clinical development opportunities.
- Oversee and conduct ongoing review, analysis, and interpretation of emergent clinical data.
- Contribute to external publications and presentations at scientific congresses and manuscripts.
- Develop and conduct advisory board meetings to inform clinical development plan.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and all other quality standards.
- Other duties as assigned.
Requirements:
- MD or equivalent.
- Minimum 3 years of industry or equivalent academic experience in conduct of clinical trials. Experience with oncology studies and subspecialty training in oncology highly preferred.
- Patient-focused, with a commitment to understanding clinical needs and improving the lives of patients with cancer or other serious medical diseases.
- Motivate to work in a fast-paced, small company environment.
- Demonstrate record of accomplishment; capable of delivering on deadlines with high quality work.
- Demonstrate ability to collaborate successfully with multiple functions in a team environment at all levels.
- Knowledgeable in all aspects of clinical trial conduct, both early and late phase, including protocol development, study start-up, execution, analysis and reporting.
- Experience in working closely with investigative sites, study investigators, CROs and other personnel involved in clinical trials.
- Solid understanding of GCP and ICH guidelines.
- Experience with Microsoft Office Suite, including basic Excel skills.
- Ability to juggle multiple activities and work under pressure.
- Results-driven and oriented individual with strong attention to detail to deliver high-quality work product.
- Ability to organize competing priorities logically.
- Ability to demonstrate strong customer focus and collaboration, and problem-solving skills.
- Ability to handle a high volume of work.
- Experience working for a biotech or pharmaceutical company preferred.
- Willingness to expand the range of job responsibilities as needed.
Position Type/Expected Hours of Work:
This is a full-time position (40 hours/week). Position is fully remote with domestic/international travel as required.
Competencies:
- Communicate in English, both orally and in writing (communication skills).
- Organize, analyze, and interpret data (critical thinking).
- Exhibit attention to detail (critical thinking).
- Plan effectively (project management; planning and organizing).
- Demonstrate creativity and resourcefulness (problem solving).
- Understand and follow directions (technical capacity).
- Remain flexible and reliable (teamwork and negotiation).
- Apply effective time management skills (time management).
- Exercise good judgment and maintain strictest confidentiality (ethical conduct).
- Follow and apply appropriate laws, regulations, policies, and procedures (ethical conduct).
Additional Information:
NiKang currently anticipates that the annual base salary range for this position is estimated to be from $150,000 to $280,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401 (k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.
Associate Director / Director / Senior Director of Clinical Science - Remote
We are seeking a qualified professional for the Associate Director / Director / Senior Director of Clinical Science. The candidate will collaborate with the clinical development team, and is responsible for performing core clinical development activities in partnership with cross-functional colleagues with responsibilities to include clinical trial design, protocol development, pharmacovigilance, review of and contribution to interpretation of clinical trial data, clinical study reports, and support for interactions with external stakeholders and health authorities as needed.
Responsibilities:
- Maintain scientific and clinical knowledge in the specific therapeutic and disease area.
- Provide scientific and clinical leadership to study teams and provide clinical science expertise at study team meetings.
- Support development of clinical strategy and clinical study design, planning, and execution.
- Support clinical protocol development and review together with cross-functional clinical team.
- Along with clinical operations, work closely with the CRO and study sites to ensure oversight of enrollment and overall timelines for key deliverables.
- Oversee and conduct ongoing review of, analysis, and interpretation of emergent clinical data.
- Support engagement with study investigators and opinion leaders.
- Contribute to external publications and presentations at scientific congresses and manuscripts.
- Contribute to the development and support of advisory board meetings.
- Lead site-facing activities such as training and serving as primary contact for clinical questions, triage with medical monitor as needed.
- Manage activities related to data generation and validation, including case report form (CRF) design, clinical data review/query resolution; ensure consistent, quality data review.
- Develop data review plan in collaboration with study team, conduct clinical data trend identification in collaboration with medical monitor.
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards.
- Other duties as assigned.
Requirements:
- MD, PhD, PharmD, or equivalent.
- Minimum 3 years of industry or equivalent academic experience in conduct of clinical trials. Experience with oncology studies is preferred.
- Proficiency in GCP/ICH, drug development process, study design, statistics, clinical operations.
- Knowledge of the establishment and operation of data monitoring committees, safety review committee, and independent date monitoring committees.
- Motivated to work in a fast-paced, small company environment.
- Knowledgeable in all aspects of clinical trial conduct, both early and late phase, including protocol development, study start-up, execution, analysis and reporting.
- Experience in working closely with investigative sites, study investigators, CROs and other personnel involved in clinical trials.
- Solid understanding of GCP and ICH guidelines.
- Experience with Microsoft Office Suite, including basic Excel skills.
- Ability to juggle multiple activities and work under pressure.
- Results-driven and oriented individual with strong attention to detail to deliver high-quality work product.
- Ability to organize competing priorities logically.
- Ability to demonstrate strong customer focus and collaboration, and problem-solving skills.
- Ability to handle a high volume of work.
- Experience working for a biotech or pharmaceutical company preferred.
- Willingness to expand the range of job responsibilities as needed.
Position Type/Expected Hours of Work:
This is a full-time position (40 hours/week). Position is fully remote with domestic/international travel as required.
Competencies:
- Communicate in English, both orally and in writing (communication skills).
- Organize, analyze, and interpret data (critical thinking).
- Exhibit attention to detail (critical thinking).
- Plan effectively (project management; planning and organizing).
- Demonstrate creativity and resourcefulness (problem solving).
- Understand and follow directions (technical capacity).
- Remain flexible and reliable (teamwork and negotiation).
- Apply effective time management skills (time management).
- Exercise good judgment and maintain strictest confidentiality (ethical conduct).
- Follow and apply appropriate laws, regulations, policies, and procedures (ethical conduct).
Additional Information:
NiKang currently anticipates that the annual base salary range for this position is estimated to be from $150,000 to $210,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401 (k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.
Associate Director/Director of GCP, QA OPS - Remote
We are seeking a qualified professional for the Associate Director / Director of GCP,QA OPS. The candidate will support clinical programs in Clinical and Research to ensure adequate oversight and management of Quality. The candidate will be responsible for the hands-on management of the GCP QA team and will support in the development and implementation of NiKang QMS. The candidate will oversee clinical study operations and quality oversight efforts for novel small molecule cancer therapeutics while playing an instrumental role in the growth of an emerging and well-positioned biotechnology company. This candidate must be well experienced in clinical study activities and quality systems to ensure NiKang’s adequate oversight of third parties (GCP) and clinical trial activities.
The candidate will provide guidance and leadership to ensure that the Quality Systems function maintains the standards expected by global regulatory authorities. This position requires expertise in Clinical Quality and relevant regulations.
Responsibilities:
- Serves as QA primary point of contact for making quality related decisions for all on-going studies.
- Ensure management remains informed on the operation of the quality system and that quality-related decisions are escalated to the appropriate levels of executive management.
- Oversee and manage the audit program for the GCP/GLP vendors and clinical sites.
- Participate and conduct GCP vendors and clinical site audits, write audit reports and ensure meaningful corrective and preventive actions are taken before closure of audit findings.
- Participate in and lead GCP/GLP compliance audits and complete risk assessments for supplier qualification (as required).
- Participate and conduct internal audits (Study-specific and/or QMS), write audit reports, and ensure meaningful corrective and preventive actions are taken before closure of audit findings.
- Review and approve, as needed, study plans, study protocols, study deviations, QMS deviations, corrective actions and/or preventive actions, among other GCP related documentation.
- Create, maintain, and revise departmental standard operating procedures.
- Support and/or host GxP regulatory and partner inspections.
- Generate reports to communicate outstanding documents, cycle times, and overall efficiency of the quality system.
- Accomplish quality and organization goals by completing related activities as assigned, thoroughly and in a timely manner.
- Ensure compliance and inspection readiness of Quality Unit by providing adequate management of the assigned Quality systems required to support GCP regulations and standards.
- Research and identify new opportunities outside of assigned work that augment the company’s mission, vision, values, and goals.
- Accept ownership for accomplishing new and different requests; explore opportunities to add value to job accomplishments.
- Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
- Write, review, and approve study documentation (protocols, risk assessments, etc.).
- Demonstrate leadership and professionalism to build relationships crucial to the success of the organization.
- Experience delivering consistently prompt, efficient, dependable, highly skilled service to multiple stakeholders.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in life sciences or related field or equivalent experience required; advanced degree and/or certifications are a plus.
- Minimum 10 years of direct hands-on experience within the pharmaceutical industry, with 5 years of leadership and management experience in the oversight of clinical trials.
- Strong leadership competencies and strategic business perspectives.
- Experience overseeing study vendors (e.g., CRO, IRT/IXRS, central imaging and laboratories) preferred.
- Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
- Experience with electronic systems (e.g., eTMF, EDC, and other data management software).
- Extensive knowledge of GCP regulations and SOP implementation.
- Excellent interpersonal and communication skills (both written and oral) as well as the ability to build cross-functional relationships and work collaboratively with other groups.
- Demonstrates a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
- Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
- Experience with Microsoft Office Suite, including basic Excel skills.
- Ability to juggle multiple activities and work under pressure.
- Results-driven and oriented individual with strong attention to detail to deliver high-quality work product.
- Ability to organize competing priorities logically.
- Ability to demonstrate strong customer focus and collaboration, and problem-solving skills.
- Ability to handle a high volume of work.
- Experience working for a biotech or pharmaceutical company preferred.
- Willingness to expand the range of job responsibilities as needed.
Position Type/Expected Hours of Work:
This is a full-time position (40 hours/week). Position is fully remote with domestic/international travel as required.
Competencies:
- Communicate in English, both orally and in writing (communication skills).
- Organize, analyze, and interpret data (critical thinking).
- Exhibit attention to detail (critical thinking).
- Plan effectively (project management; planning and organizing).
- Demonstrate creativity and resourcefulness (problem solving).
- Understand and follow directions (technical capacity).
- Remain flexible and reliable (teamwork and negotiation).
- Apply effective time management skills (time management).
- Exercise good judgment and maintain strictest confidentiality (ethical conduct).
- Follow and apply appropriate laws, regulations, policies, and procedures (ethical conduct).
Additional Information:
NiKang currently anticipates that the annua0 base salary range for this position is estimated to be from $140,000 to $200,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401 (k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.
Senior Director / Executive Director / Vice President of Human Resource - Remote
We are seeking a highly motivated, hands-on candidate for the position of Senior Director/Executive Director/VP of Human Resources. The candidate will report to the CEO, and provide executive-level leadership and guidance to the organization’s HR strategy. The candidate will be responsible for talent recruitment, enforcing legally compliant human resources policies, nurturing a culture rooted in collaboration and respect, and promoting a high-performance environment in support of our rapidly expanding organization.
Responsibilities:
- Develop people strategy to support the company’s business.
- Build strong and effective relationships with executives, managers and employees to become a trusted partner and coach throughout the organization. Hold the organization accountable to its core values.
- Develop and implement effective recruiting strategies. Provide counsel to hiring managers. Manage candidate relationship.
- Identify gaps in culture, training and development, performance management, and HR processes. Develop strategies and timelines to address these gaps based on business objectives.
- Provide day-to-day support to employees regarding HR practices, employee relations, and developments.
- Monitor and ensure the organization’s compliance with federal, state, and local employment laws and regulations, recommend best practices, review and modify policies and practices to maintain compliance.
- Provide counseling and dispute resolution regarding employee issues through consultation and investigation with both employees and leaders, reviewing company policies and practices and providing recommendations for resolution.
- Interpret company policies where applicable to ensure consistent application and equitable employee relations.
- Handle discipline and termination of employees in accordance with company policy.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in human resources, Business Administration, or related field required; Masters or law degree highly preferred.
- Minimum of 15 years progressive Human Resource experience in employee relations, talent management, recruiting and training.
- Proven leader in HR areas such as employee relations, HR compliance/process, talent management, professional development, performance management and culture building.
- Knowledge of local, state and federal laws and regulations regarding employment practices.
- Experience with Microsoft Office Suite, including basic Excel skills.
- Ability to juggle multiple activities and work under pressure.
- Results-driven and oriented individual with strong attention to detail to deliver high-quality work product.
- Ability to organize competing priorities logically.
- Ability to demonstrate strong customer focus and collaboration, and problem-solving skills.
- Ability to handle a high volume of work.
- Experience working for a biotech or pharmaceutical company preferred.
- Willingness to expand the range of job responsibilities as needed.
Position Type/Expected Hours of Work:
This is a full-time position (40 hours/week). Position is fully remote with minimal travel requirement.
Competencies:
- Communicate in English, both orally and in writing (communication skills).
- Organize, analyze, and interpret data (critical thinking).
- Exhibit attention to detail (critical thinking).
- Plan effectively (project management; planning and organizing).
- Demonstrate creativity and resourcefulness (problem solving).
- Understand and follow directions (technical capacity).
- Remain flexible and reliable (teamwork and negotiation).
- Apply effective time management skills (time management).
- Exercise good judgment and maintain strictest confidentiality (ethical conduct).
- Follow and apply appropriate laws, regulations, policies, and procedures (ethical conduct).
Additional Information:
NiKang currently anticipates that the annua0 base salary range for this position is estimated to be from $150,000 to $280,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401 (k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.
