Jobs

 

Director, Statistics in north Chicago, IL

 
Overview:

  • Protocols: Directs the development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Develop project and functional standards of data collection and analysis, and implement these standards.
  • Database Activities: Collaborate with Data Sciences, Statistical Programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Guide development and implementation of project-specific data standards. Guide and ensure timely execution of all database-related DSS activities for project.
  • Statistical Analyses: Demonstrate excellent understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine need for development of novel statistical methodology.
  • Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analyses. Prepare oral and written reports to communicate results. Represent Data and Statistical Sciences on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications with high quality.
  • Consultation: Interact with stakeholders so that appropriate statistical methods are adequately and consistently applied in deliverables. Provide statistical insight in addressing questions. Propose novel solutions to technical issues. Independently pursue analyses suggested by data, including the pursuit of statistical knowledge needed.
  • External Engagement: Act as the liaison for statistical and operational issues on  collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures, CROs, temporary staff or licensing activities. Build external scientific contacts which foster professional development and promote the reputation of the department. Works with Director to build relationships between department and outside investigators and medical/scientific exp
  • Project Team Involvement: Partner with Clinical and Regulatory to create development strategies. Represent DSS on project team(s) to provide statistical input to compound/drug development and align with DSS management. Lead communication between assigned project team(s) and DSS to ensure timely communication, proper strategies, and alignment of decisions/priorities between project team and DSS management. May represent DSS on data monitoring committees. Build interdepartmental relationships.
  • Training and Supervising: Train and mentor staff on statistical methodology and operations. Develop and supervise seminars, short courses and publications. Gain expertise in innovative statistical methods. Along with functional leaders, manage statistical resources (Including CROs) to meet project priorities. Recruit qualified personnel and arrange training for professional development of staff. People managers will manage 2 or more direct reports.
  • Regulatory Activities: Work with Director to ensure that development programs incorporate sufficient statistical rigor and quality to meet global regulatory requirements. Critically review regulatory submission documents. Ensure appropriate functional representation at regulatory agency and advisory committee meetings. Ensure all applicable regulatory requirements for work processes are met. Ensure validation of statistical software to meet SOPs and regulatory requirements.
  • Compliance: Compliant with applicable corporate and divisional policies, procedures and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the Statistics function. Ensure compliance with department standards, GxP and best operating practices for staff and self. Complete all assigned training on time.
   
Level will be based on education and years of experience.

Qualifications:
  • MS (with a minimum of 12 years of experience) or PhD (with a minimum of 8 years of experience) in pharmaceutical development is required. Degree should be in Statistics, Biostatistics, or a highly related field
  • Excellent English communication skills, both oral and written.
  • Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
  • Experience in leading NDA, BLA, and or CTD submission preferred (for clinical statistics only). Understanding of and global regulatory requirements. Experience interacting with regulatory agencies highly desirable.
  • Management experience required.
Security Clearance Required: No
Visa Candidate Considered: Yes
COMPENSATION
Base Salary - $170,000 to $200,000 
Full-time Benefits - Full 
Relocation Assistance Available - Yes 
CANDIDATE DETAILS
10+ to 15 years experience
Seniority Level - Director
Management Experience Required - Yes
Minimum Education - Master's Degree
Willingness to Travel - Occasionally

 

Sr. Scientist I/II Formulation in Novato, Ca

 

Job Description Summary

Responsible for leading biologic protein and/or AAV gene therapy formulation and process development. The candidate should possess the skills to utilize a diverse array of analytical instruments to characterize protein and/or AAV formulations. The ideal candidate is a self-starter familiar with the literature and keeps up with new developments in the field and is thus able to identify opportunities for new innovation. Position makes use of scientific expertise and understanding of the industry to develop and contribute to complex company objectives. Position acts independently in selecting scientific approaches and defining acceptance criteria. Position regularly contributes proposals and influences decision-making within the department and technical teams, and at times beyond his/her own department and projects. Responsibility entails early formulation screening/characterization studies through late-stage formulation/process optimization and technology transfer to CMO. Develops conceptual designs and leads advanced independent or multi-disciplinary development projects driven by project needs. Provides technical leadership and guidance to formulation development and consultation to junior scientists on experimental designs and technical issues. The candidate has established scientific expertise in protein and/or AAV gene therapy formulation and process development.  

Responsibilities

  • Experimental design and strategic planning of drug product formulation development throughout all stages of non-clinical, clinical and commercial development
  • Collaborates in a matrix organization with Research, Preformulation, Process Development, Analytical Chemistry, Manufacturing (internal and external), Market Planning, and Regulatory Affairs to deliver project objectives
  • Serves as formulation representative on multi-disciplinary project teams
  • Provides scientific guidance and consultation to junior scientists on experimental designs, trouble shooting, data interpretation and technical challenges
  • Develops conceptual designs and experiments to solve technical issues
  • Leads the development and optimization of protein and/or AAV formulations
  • Serves as scientific monitor for outsourced formulation development, technology transfer or manufacturing at CMOs or CDMOs
  • Presents experimental results and recommendations to project teams, provides updates of project status, risks and mitigation strategies in the context of overall program goals
  • Generates written technical reports and contribute to regulatory submission documents
  • Develops protocols for various stability studies in collaboration with team members and external partners to support various programs in early and late stage development
  • Maintains state-of-the-art scientific knowledge, specifically with regard to biological drug product development and innovatively integrate new technologies into the work stream within the company

Education and years of industry experience

Advanced degree in Biochemistry; Pharmaceutics Sciences, or related fields with a minimum of 5 years of industry experience in biologic formulation development for Sr. Scientist I and a minimum of 8 years of industry experience in biologic development for Sr. Scientist 2. 

Experience

  • Experience with biologic formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings
  • Must have in-depth understanding of the biophysical and biochemical degradation pathways for protein in liquid formulation
  • Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC, DSC, UV Spectrophotometry, SEC-MALS, Fluorescence Spectroscopy, MFI, HIAC, SLS, DLS
  • Experience with GMP fill/finish process and equipment including Aseptic Filling Equipment, Production Capping Machine, Lyophilizer, etc. is preferred
  • Utilize DoE principles to design formulation screening/optimization studies and perform statistical analysis of collected data
Skills and Ability requirements 
  • Excellent oral presentation and scientific writing skills are essential
  • Strong scientific contribution skills as demonstrated through patents, publications, technical reports, and approved regulatory submissions
  • A strong team player with good collaborative and people skills
  • Strong organization and prioritization skills, attention to details and ability for in-depth research and analysis
  • Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
  • Ability to work in a fast paced environment, must be willing and able to juggle multiple projects at the same time
COMPENSATION
Base Salary - $122,000 to $183,000
Full-time Benefits - Full 
Relocation - Yes

 

Sr. Director, Bioinformatics Development in Pleasanton, Ca

 

Position Summary: 

The Senior Director of Sequencing Bioinformatics Development is the lead for bioinformatics product development at multiple sites.  The position requires an in-depth understanding of productizing bioinformatics analysis software in a regulated environment and interfacing with research and product development counterparts in reagent, assay, software engineering, medical and scientific affairs, quality and regulatory, and information technology.

We are looking for a leader with a deep understanding of bioinformatics product development with experience including secondary analysis algorithms, regulated diagnostic environments and software engineering. Your challenge is to productize a range of complex bioinformatics analysis tools and algorithms while providing the necessary support to reagent and assay development teams in a global organization.

Responsibilities Include:

  • Provide technical and strategic leadership as a member of the lifecycle teams to support decision making in oncology and reagent applications product development.
  • Lead multiple bioinformatics teams responsible for development of secondary NGS analysis algorithms, in collaboration and support of reagent / assay development.
  • Support bioinformatics analysis activities for reagent / assay product development via use of external/internal tools as well as direct analysis and interpretation.
  • Establish, implement and maintain uniform operational processes regarding high performance computing, dev-ops, design control and good programming practices across NGS bioinformatics development teams.
  • Cultivate technical programs that enable bioinformaticians participating in cross-functional teams to succeed at solving a range of software product development challenges in a matrixed environment.
  • Provide bioinformatics professional development coaching and mentorship on analytical and clinical validation procedures in the context of clinical diagnostics.
  • Serve as a member of the Software and Bioinformatics Leadership Team (S&BI LT) representing Bioinformatics Development.

Minimum Qualifications and Skills:

  • PhD degree (bioinformatics, computer science, statistics or other quantitative field is preferred) with a strong publication record.
  • 10 years relevant experience including 8+ years experience in a supervisory role particularly interdisciplinary (bioinformatics) teams.
  • Broad experience with next-generation sequencing assay development required.
  • Experience working in a diagnostic organization is required while experience with regulatory approvals of in vitro diagnostic medical devices preferred.
Security Clearance Required: No
Visa Candidate Considered: No
COMPENSATION
Base Salary - $235,000 to $260,000 
Full-time Benefits - Full 
Relocation Assistance Available - Yes 
CANDIDATE DETAILS
10+ to 15 years experience
Seniority Level - Director
Management Experience Required - Yes
Minimum Education - Doctorate Degree
Willingness to Travel - Occasionally
SCREENING QUESTIONS
Will you now, or in the future, require sponsorship to work in the US?
Relocation - if the person lives outside of the SF Bay Area, where are they needing to relocate from? This is not a remote position.
IDEAL CANDIDATE
  • Clinical Bioinformatics Algorithm development;
  • Leadership for the organization they are responsible for;
  • Subject matter expertise – technically deep, design review, get into the details of the algorithm, provide technical knowhow/subject matter expertise to the org they lead, comfortable hands on, technical stewardship.
 

Biostatistician in Santa Clara, Ca

 

Reporting to the Biostatistics manager you will join a team of 4 biostatisticians and data analysts, to support a larger multidisciplinary team. 

 In this exciting role you will have responsibility for developing study designs and statistical analysis plans and will work closely with scientists and pathologists.

Responsibilities/Deliverables:

  • Prepares statistical analysis plans and writes detailed specifications for study design and analysis methods. Performs analyses, interprets results and writes statistical summaries.
  • Supports cross-functional teams in the planning, design, conduct, and reporting of studies, as well as in regulatory submissions, to meet project objectives, including verification, validation, and clinical studies.
  • Collaborates with pharmaceutical partners in support of clinical development projects and presentations/publications.
  • Communicates with the FDA regarding statistical analysis issues. Provides technical and strategic support in resolving issues.
  • Stays up-to-date on new developments in statistics, molecular technology, drug development and regulatory guidance through literature review, industry workshops, etc.
Geographic location: Santa Clara, CA or Carpinteria, CA 

Required Qualifications

  • Master's Degree Biostatistics or equivalent 2+ years relevant work experience
  • Strong knowledge of statistical (theoretical) principles and applied statistics.
  • Experience with statistical software such as R and SAS.
  • Good understanding of molecular biology, cancer, immunology, genetics or genomics in addition to standard molecular assays and technologies.
  • Ability to create study specifications and provide support in the review of data management documentation.
Qualifications (preferred):
  • PhD in Biostatistics or equivalent
SKILLS AND CERTIFICATIONS [note: bold skills and certification are required]
Master's Degree Biostatistics or equivalent 2+ years relevant work experience 
Good understanding of molecular biology, cancer, immunology, genetics or genomics in addition to standard molecular assays and technologies.
Security Clearance Required: No
Visa Candidate Considered: No
COMPENSATION
Base Salary - $93,696 to $146,400 
Full-time Benefits - Full 
Relocation Assistance Available - Yes 
CANDIDATE DETAILS
2+ to 5 years experience
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Master's Degree
Willingness to Travel - Occasionally
IDEAL CANDIDATE
Will have 2+ years' experience in diagnostics 
2+ year's experience can be from academia
 

Sr. Regulatory Affairs Specialist in Pittsburgh, PA

 

Summary:

The ideal person for this job should have a Bachelors degree, and a scientific discipline is required.  You should have a 5-7 years previous related experience, expert knowledge and understanding of global regulations relevant to Class III and/or Class III medical devices. We need someone who can come aboard, quickly learn our processes and start making an impact on our organizations.  Responsibilities include:

  •  Develop and implement global regulatory strategies designed to:
    • reduce product development cost/time
    • achieve faster-than-average review times with regulatory bodies
  • Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy.
  • Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives.  Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions.  Interact with regulatory agencies as part of submission review and on-site audit support.
  • Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
  • Develop strategies and contingency plans for projects, including those that are most complex and challenging
  • Anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
  • Key member in RA committee (e.g., AdvaMed, standards/committee) and provide input in the development of standards/regulations that affect the Medical Device industry
COMPENSATION
Base Salary - $81,000 to $102,000
Full-time Benefits - Full 
CANDIDATE DETAILS
5+ to 7 years experience
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
IDEAL CANDIDATE
Below are notes from my intake call with the hiring manager. 

 How does this role contribute toward the organizations’ strategic goals? Jumping through legal and regulatory hoops to get the affairs in order 
What makes this role “attractive”? (for passive candidates) working on clearance on regulatory approvals, market expansion, cutting edge pulmonary technologies 
What are the minimum technical requirements of this role?  An engineering or technical background is essential. Must also work independently.  
Would you consider a candidate who has potential to grow in this role vs. someone who comes with out of the box experience? They would need to hit the ground running.  
What are your deal breakers, what do you NOT want to see? Medical Device person is required.  
Are there any specific, certifications, keywords, experience that would make this person standout as a top candidate for this role? Technical regulatory, European medical device regulation, standards compliance, medical device regulation  
How much industry experience a must have? 5 years plus  
Target companies: Abbott, anything with medical devices  
Why did others not work out in the role, if applicable? Written and spoken communication, someone who needs a lot of hand holding may not work out.  
 

Sr. Statistician, Research in Lake County, IL

 
OVERVIEW: 
  • Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies
  • Develop standardized reusable JReview Objects and Views. Work with Medical Safety Evaluation (MSE) and PST Statisticians to formulate, conduct, and interpret appropriate queries of safety data using JReview and other analytic tools. Develop, as needed, ad-hoc JReview objects and views for evaluating potential safety signals. Champion and promote the use of safety review tools (e.g., JReview and SDRT) among PST physicians and MSE.
  • Participate in the development and subsequent utilization of statistical tools for conducting meta-analyses of safety date & for benefit-risk analyses
  • Works collaboratively with multi-function teams to complete project deliverables per agreed timelines. Keeps management Informed on important scientific/statistical issues that may arise, in a timely manner.
  • Provides responses to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data. Responsible for developing and maintaining good client relationships
  • Communicates a basic understanding of scientific principles for assigned projects and acts in accordance with those principles. Clearly communicate fundamental statistical concepts to other statisticians, scientists, and other personnel.
  • Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings
  • Presents own statistical research or review of the statistical literature at meetings and seminars.
  • Participates in departmental activities including recruiting , training/mentoring, research efforts and cross-functional collaborations, as necessary
QUALIFICATIONS:  
  • MS or PhD in Statistics, Biostatistics or a highly related field. 0+ years (PhD) or at least 4-6 years (MS) of relevant experience required
  • High degree of technical competence and sound communication ability, both oral and written
  • Competent in experimental design, descriptive and inferential statistics, biometrics/biopharmaceutical applications and computer programming.
  • Identifies data or analytical issues and either applies skills and knowledge to solve problems or seeks help to achieve solutions
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
  • Learns fast, grasps the 'essence' and can change the course quickly where indicated
Visa Candidate Considered: Yes
COMPENSATION
Base Salary - $100,000 to $125,000 
Full-time Benefits - Full 
Relocation Assistance Available - Yes 

CANDIDATE DETAILS
5+ to 7 years experience
Seniority Level - Mid-Senior
Minimum Education - Master's Degree
Willingness to Travel - Occasionally
 

Sr. Associate, Regulatory Affairs Manager International in San Rafael, Ca

 

SUMMARY

We are seeking a highly motivated, energetic professional capable of working effectively in a fast-paced environment to join our Regulatory Affairs International team. The Regulatory Affairs International Manager is responsible for supporting global regulatory activities for new product registration and life-cycle maintenance in Latin America, Asia Pacific, Eastern Europe/Asia Minor and Middle East/Africa. 

RESPONSIBILITIES

  • Understand regional laws, regulations, guidance, and global regulatory requirements while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.
  • In conjunction with regional leads and experts, manage project timeline, planning and preparation and submission of marketing applications, orphan drug applications and variations to support LATAM, APAC and EEAM/MEA regions. Must ensure all submissions are prepared in accordance with regional regulations.
  • Participate on interdisciplinary regulatory teams in establishing global regulatory strategy
  • Provide regulatory support to team members located in global offices.
  • Manage the writing or updating of various sections of the MAs including the administrative, labeling, nonclinical, and clinical portions of MAs.
  • Act as a main point of contact for specific projects and serve as an international regulatory representative on project sub-teams. The candidate will need a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry.
  • Participate in international health authority meetings, as required.
  • Communicate with regulatory consultants regarding product development plans.
  • Perform regulatory intelligence searches for registration and other regulatory requirements in applicable global regions.
  • Flexible work schedule to maximize global interactions, as required.
  • Up to 10% travel for regional business, health authority meetings, etc. may be expected.

EXPERIENCE

Required Skills:

  • Minimum of 4-5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Regulatory environment. International regulatory experience preferred.
  • Proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
  • Ability to successfully manage multiple projects to deadlines.
  • Thorough understanding of relevant drug development and post-marketing regulations and guidelines and have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
  • Skilled at gathering supportive information and developing product approval strategies.
  • Proven track record of achieving regulatory goals in ambiguous and sometimes challenging situations.

Desired Skills:

  • Rare disease experience is preferred
  • International experience is preferred
  • Bilingual/multilingual language skills are a plus

EDUCATION

  • Bachelor's degree in a science/life sciences. 
COMPENSATION
Base Salary - $90,000 to $120,000 
Full-time Benefits
Relocation Assistance Available 
CANDIDATE DETAILS
5+ to 7 years experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
   
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