Boston’s Top Biotech Recruiters

What does it take to be Boston’s Top Biotech Recruiter?

It is not enough to search for those who are actively looking for jobs; we  study those who might not be actively looking for job placements.  There are constantly a few people who might be cultivated and interested in the positions you need to provide. Capitalize on this. Set up strong relationships with people anyplace you pass; every body you meet could be a destiny worker for the biotech industry.

To choose an biotech recruiter agency, do the same preparation you would do when assessing a candidate. Look at their LinkedIn or blog profile for their experience. Is there evidence of their experience in the biotech or biopharma position you want them to work in?

It is very important when choosing a recruitment agency that you can personally meet them in their area. Some of the best biotech recruitment agencies such as Sci.bio Recruiting are found in Boston, Massachusetts.

We know that your biotech company requires some of the best talent. So when you do have a position to fill however, a logical first step is to submit the location inside your biotech agency.

You can have an untapped gold mine of capacity right beneath your nose.Ask for an opinion concerning the worker’s strengths, their likes and dislikes in their contemporary role, and what their precise performance challenges might be.

Interview the biotech recruiters just as you would a candidate for employment. Ask: Do you have candidates for my position already in your database? How will you find and assess the candidates for my position? How will you keep me up-to-date on the status of candidates? How long will it take to fill the position?

You would possibly want to recall administering competency assessments periodically for your present biotechnology employees in order to decide what resources you have already got in your exertions pool need to a gap end up to be had.

For permanent, strategic positions, biotech employers should consider the biotech firm’s expertise and track record in that biotechnology and biopharma vertical. When was the biotech firm’s most recent fill? What’s the reach of the pharmaceutical recruiters network?

Some other element to keep in mind is to observe the equal hiring system and pointers you’ve set up. Generally, biotech hiring managers will pass over key elements while thinking about internal applicants. Do no longer make assumptions approximately the employee’s overall performance or capacity. Follow the hiring manner. stay as objective here as you will be with any other candidate.  It is always a good concept to remain consistent both in criteria and process no matter who the candidate is, or wherein he or she comes from.

Does this biotech recruitment firm or its recruiters provide tips or any help in making sure your resume looks its best for potential employers? A good pharmaceutical recruiter or recruitment agency will do its best to put you in the best light. They know they have a major role in your success, so they will help you even in as simple as preparing up your resume.

What Recruiters are Looking for to Fill Pharmaceutical Positions

Pharmaceutical Recruiters and hiring managers can actually receive hundreds of applications for a single position and only have time to review CVs before deciding whether to move a candidate toward an interview.

In order to make an immediate impact, your resume or CV will need to disclose the following information in the most concise manner.

 

Experience

Experience! Ensure your experience – whether 3months in one position or 2 years in another, comes across as harmonious and appropriate to the job you’re applying for.

Your Roles

You’ll need to tailor your resume to each particular biotech or pharmaceutical job that you apply for, so it’s vital that the job titles and the responsibilities you include in your resume are suitable for the position offered.

Results and Achievements

Hiring managers love to see results, so if you achieved above your target as a Sales Manager, for example, make sure you state your targets as amounts or percentages and demonstrate how you’ve overachieved.

Skills

Ensure you include all relevant skills gained and required of you in previous roles. Your skills will complement your experience and should ultimately illustrate your suitability for the job offered.

Submitting Resume in Person

When you are searching for a pharmaceutical job near your city or state, be sure to find a recruiting firm that specializes in the niche industry. There are far too many large recruitment firms that cover a large gamut from software to biotech. A good example of a boutique recruitment firm is Sci.bio Recruiting.

Education

Be sure you highlight important certificates, particularly when they’ve been listed as essential or desirable in the biotech, biopharma. pharmaceutical, or life science industry.

Easy to Read

Use bullet points to outline skills, achievements, responsibilities, etc. rather than rambling sentences. Ensure the layout of your life science resume is clear and consistent, containing only one type of font (bold can be used to highlight).

No Inconsistencies

Ensure your resume runs in reverse chronological order and is written as accurately as possible. Make sure there are no unexplained gaps in your work history or inconsistencies in the responsibilities or achievements you’ve included.

Appropriate Language

Ensure you include important keywords throughout your resume. To do this, scan the job description and make sure your language mirrors it. Be sure your keywords in your resume include terms that are used in scientific testing, etc.

Format and Label

Ensure your resume is formatted in such a way that the recipient will be able to open it easily. Be sure that it is in a PDF format and if you include links they should be verified.

 

 

Clinical Validation Associate

Clinical Validation Associate

  • Job Description

    In this role, you have the opportunity to

    Join a dynamic, fast-moving team testing best-in-class Healthcare Informatics and Patient monitoring solution.  You will be part of an established team committed to innovation and contribution, trust and respect, teamwork and an uncompromising integrity. You will become a member of the clinical research and validation team and participate in the clinical product development life cycle from concept through creation.

    You are responsible for

    • Owning a project facilitating all clinical research activities which includes usability testing, use model verification and clinical system reliability.
    • Cultivating effective working relationships with key worldwide customers as well as internal cross functional team members.
    • Coordinating the planning, implementation and monitoring of Clinical Validation activities based on high-level guidance from clinical research manager. This includes; clinical testing planning, protocol development, investigator selection, study contracting, go-live logistics, and basic training of internal and external personnel.
    • Actively participate and contribute to requirements, specifications, use model definitions, business teams, and risk management process as a member of a product cross functional team.
    • Providing post go-live study monitoring to insure patient safety, adherence to the protocol, adequate reporting of feedback, and adverse events in clinical test.
    • Conducting project and process retrospectives to ensure process improvement opportunities are capitalized.
    • Writing/editing of study reports for business and regulatory submission as well as assist in the preparation of manuscripts, abstracts, book chapters, posters and in-house publications in cooperation with clinical investigators.

    You are a part of

    At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people centric learning, total rewards and personalized development planning programs.

    To succeed in this role, you should have the following skills and experience

    • 5-8 years of clinical healthcare experience as an RN, NP, PA or similar
    • Relevant BS/BA in a related health science or equivalent required
    • Strong organizational and interpersonal skills
    • Desired qualifications:
      • Working regulatory knowledge (FDA/21CFR812; EN540/GCP; ISO14971)
      • EMR experience
      • Experience with clinical study, clinical trials or clinical claims research
      • Industry experience in clinical claims for technology products
      • Experience with clinical information systems implementation and training
      • Clinical IT or informatics experience
    • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

    • Company relocation benefits will not be provided for this position. Candidates need to live within the territory or within commuting distance to Andover, MA.

    In return, we offer you

    At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people centric learning, total rewards and personalized development planning programs.

    Why should you join Philips?

    Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

    To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

    Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

    As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Research Associate – Molecular Biology

RESPONSIBILITIES
  • Work as part of the R&D team responsible for the development of the next generation technology at the company
  • Develop new bio-assays and optimize existing assays
REQUIREMENTS
  • The ideal candidate will have a bachelor’s with 3+ years of industrial experience in molecular biology, with excellent knowledge of PCR based techniques, DNA/RNA isolation and purification, primer design, genomic database mining, hands-on attitude and an innovative approach to problem solving
  • Excellent command of scientific fundamentals and is able to translate that into their laboratory work
  • Creative and goal-oriented
  • Familiarity with laboratory instrumentation and instrument control paradigm
  • Must be comfortable using skills and knowledge to problem-solve outside of their comfort-zone and learn on-the-fly if necessary
  • Good interpersonal skills and the ability to work in interdisciplinary teams are essential
  • Bio-assay development and QC experience is highly desirable
  • Experience with automation, protein expression, and purification, is a plus
  • Excellent written and oral communication skills will complete the profile

Genomics Data Scientist

Genomics Data Scientist

Job Description:

Genomics Data Scientist

Brown University, Computing and Information Services seeks two qualified applicants for the position of Genomics Data Scientist. There are two opportunities available. All applications will be considered for both positions.

The Genomics Data Scientist will be charged with the development, implementation, and technical support for research projects within the Computational Biology Core of the CIS Data Science Practice. He or she will apply robust software engineering techniques to develop workflows and web applications for analysis and visualization of genomics data generated by collaborators of the Core, serving as a computational and bioinformatics analyst for assigned projects. The Genomics Data Scientist will be an active participant in exploring creative new approaches for leveraging existing tools and publicly available genomics data in alignment with the vision of the Center of Biomedical Research Excellence. The Genomics Data Scientist will work collaboratively with other members of the Data Science Practice, which includes the Computational Biology Core as well as data scientists who more broadly support data-intensive research across the university.

This is a three year fixed-term staff position, with the possibility of an extension contingent upon available funding. The grade level of the position will be determined based on the qualifications of the chosen candidate.

Qualifications:

  • For grade 9E – Bachelors Degree required and 1 or more years of work or internship experience
  • For grade 10E – Advanced Degree required and 2 – 3 years of work experience including post doc or research assistanceship
  • Working knowledge of Python, R, SQL, bash scripting, and the Linux operating system.
  • Working knowledge of a compiled programming language, such as C, C++, Java or FORTRAN.
  • Familiarity with bioinformatics resources (e.g. NCBI), genomics databases, and related tools and file formats.
  • Expertise with formal software engineering practices, including testing, continuous integration, Git and branching models (e.g. gitflow, fork & pull request), containerization (e.g. Docker), agile development, and minimum viable products.
  • Expertise in many of the following areas:
  • Exploratory data analysis and visualization methods
  • Web application development
  • Databases and data management
  • Algorithm design and evaluation
  • Statistical methods and machine learning
  • High-performance and distributed computing
  • Cloud computing
  • Docker and containerization
  • Ability to work both independently and as a team member.
  • Ability to manage multiple projects with competing priorities and deadlines, and an eagerness to take ownership of challenging and open-ended assignments.
  • Coursework in biology preferred.

Candidates please note: a cover letter and current resume must be submitted with your application to be considered for these positions. Additionally, all offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown.

Recruiting Start Date:

2016-12-06-08:00

Job Posting Title:

Genomics Data Scientist

Department:

Office of CIO

Grade:

Grade 10

Worker Type:

Employee

Worker Sub-Type:

Fixed Term (Fixed Term)

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Still Have Questions?

If you have any questions you may contact employment@brown.edu.

EEO Statement:

Brown University is an E-Verify Employer.

Brown University is committed to fostering a diverse and inclusive academic global community; as an EEO/AA employer, Brown considers applicants for employment without regard to, and does not discriminate on the basis of, gender, sex, sexual orientation, gender identity, national origin, age, race, protected veteran status, disability, or any other legally protected status.

Clinical Research Associate

Clinical Research Associate

 Job ID: 203018

  Greater St. George & Cedar City area

Details:

About Us
What does it mean to be a part of Intermountain Healthcare? It means that the quest for clinical excellence is not just a goal, but a given. It means building an environment where physicians and employees can deliver the best in healthcare. And it’s realizing each employee or volunteer is vital to the healing process, because we can only achieve the extraordinary together.

Being a part of Intermountain Healthcare means joining with a world-class team of over 36,000 employees and embarking on a career filled with opportunities, strength, innovation, and fulfillment. Our mission is: Helping people live the healthiest lives possible.

Our patients deserve the best in healthcare, and we deliver.

Job Description

The purpose of this position is to assist in duties and activities associated with supporting clinical research and research studies at Intermountain Healthcare. A key responsibility of this position is to provide support to clinical research coordinators, clinical investigators, physicians, nurses, department managers and other staff.

Essential Job Duties

The following will be done under direct supervision:

  • Assists in the screening participants by assessing eligibility for research protocols and potential for commitment to project.
  • Assists in the monitoring of participant progression throughout study and conduct evaluation at end of study.
  • Coordinate clinical patient information according to research protocols and assist the physician or residents with gathering pertinent clinical information.
  • Safely operate laboratory equipment and comply with all regulations.

Posting Specifics

  • Benefits Eligible: Yes

Minimum Requirements

  • Two years of research experience.
  • Experience using basic computer programs including word processing, database, spreadsheet applications and e-mail.
  • Experience using laboratory protocol, systems and documentation techniques.

 

Physical Requirements

  • Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues.
  • Frequent interactions with patient care providers, patients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, alarms, needs, and issues quickly and accurately.
  • Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper – requiring the ability to move fingers and hands.
  • Expected to bend, lift, and carry patient files, documents, equipment, and supplies.
  • Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.

 

Preferred Requirements

  • Associates Degree or higher.
  • Prior experience with specimen processing
  • Prior experience with chart reviews

 

Please Note

All positions subject to close without notice. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Additional Details:

Working Hours 40
Primary Work Location Dixie Reg River Road
Expertise Research / Specialty Services / Education
Job Type Full Time
Location US-UT-St George

Genetic Counselor – Pediatrics

Genetic Counselor – Pediatrics

JOB NO:500645
WORK TYPE:Staff Full-Time
LOCATION:Main Campus (Gainesville, FL)
CATEGORIES:Health Profession, Research/Scientific/Grants
DEPARTMENT:29091100 – MD-PEDS-GENETICS

CLASSIFICATION TITLE: Genetic Counselor
JOB DESCRIPTION: – This position will be responsible for managing genetic counseling interactions during medical clinics held either in Gainesville or in the outlying areas. The genetic counselor will also participate in the telemedicine program as backup for the other genetic counselors. The genetic counselor will meet with families in clinic and gather information about genetic risks. Genetic counselor will interpret such information in consort with an MD geneticist and will provide follow-up documentation of genetic counseling recommendations.

– Oversight of the Florida Expanded Newborn Screening Program in conjunction with Geneticists and Nutritionists for both metabolic and cystic fibrosis screens. Responsible for contacting families and their physicians with abnormal NBS results, arranging for diagnostic studies, and providing genetic counseling.

– Provision of inpatient consultations, interactions with attending physicians, patients, residents, medical students and other medical personnel.

– Administrative duties as assigned by the Division Chief and Senior Genetic Counselor.

– The genetic counselor will work with divisional staff to coordinate appointments, referrals and collection of appropriate records. Will oversee the overall activities of the clinical genetics program as it relates to the provision of genetic counseling.

– Will provide educational lectures through the School of Medicine and through Children’s Medical Services, Center for Autism and Related Disabilities, or other organizations as required as part of the Regional Genetics Grant with the state of Florida.

– Will participate in the hiring and training of new genetic counselors, dietitians, and front office staff.

ADVERTISED SALARY: $55,000-$62,000; commensurate within this range based on qualifications and experience.
MINIMUM REQUIREMENTS: Master’s degree in genetics counseling or a related field from a program accredited by a national certification board for medical genetics personnel, and one year of professional genetic counseling experience, or equivalent.
PREFERRED QUALIFICATIONS: Master’s degree in genetic counseling.
Board certified or board eligible by the American Board of Genetic Counseling.
SPECIAL INSTRUCTIONS TO APPLICANTS: This is a time limited position.

Normal work hours are Monday through Friday 8:00 am to 5:00 pm.

In order to be considered for this position, applicants must upload a Cover Letter or Letter of Interest, Curriculum Vitae or Resume and List of References.

This requisition has been reposted. Previous applicants do not need to reapply.

HEALTH ASSESSMENT REQUIRED: Yes

Core Technician I – Cell Therapy

Core Technician I – Cell Therapy

Job Description Summary

Responsible for participating in upstream and/or downstream aseptic manufacturing of clinical and/or commercial grade cell therapeutic products in accordance to established SOPs, maintaining and stocking clean room environment, and monitoring expiration of materials. Completes Cell Therapy Department Training plan in order to contribute to the client specific manufacturing campaigns.

Job Description

Completion of On-The-Job Training for job related and ancillary processes and responsibilities associated with Cell Therapy Manufacturing:

  • Completes Cell Therapy General Training Plan including:
    • Equipment Maintenance and Usage
    • Cell Bank General Aseptic Processing Skills
    • Environmental Monitoring (Paper System and MODA System)
  • 5S, iGen Generation and Completion
  • Ordering & Receipt of Controlled Documents and Autoclaving for production
  • Ordering & Receipt of Controlled Labels
  • Creation and preparation of in-process labels and production binder compilation
  • Sample Submission
  • Final Product Submission to Warehouse
  • Qualification on SAP Transactions ZCOR6, COR6, COR3, and CORT – in order to demonstrate an understanding of the material management system
  • GMP Documentation practices
  • Trackwise

Execution of the job related and ancillary processes associated with cell therapy manufacturing:

  • Demonstrates technical proficiency and knowledge expansion in:
    • Equipment Maintenance and Usage
    • Cell Bank General Aseptic Processing Skills
    • Environmental Monitoring (Paper and MODA System)
  • Demonstrates basic understanding of the high level cell culture foundations and process overview
  • Demonstrates technical skill proficiency (minimal operator related PRs, excursion hit rate within historical norms)
  • Demonstrates EM proficiency (limit the number of operator related EM deviations)
  • Demonstrates proficiency on 1-2 client specific projects
  • Able achieve 70-75% yearly utilization rate
  • Able to maintain consistent SOP Compliance rate at or above 95%
  • Follows Standard Operating Procedures and Master Batch Records as written
  • Demonstrates basic GMP documentation proficiency
  • Demonstrates introductory level competency withTrackwise system and problem record initiation

Regulations:

  • Understanding and Compliance in the execution of GMPs in a manufacturing environment
  • Compliance with all safety policies, rules, and general regulations (i.e. Safety Chat attendance, 5S and EPS Observations)

Perform other duties as assigned.

 Stem Cell Research Technician

 Stem Cell Research Technician

Filing Deadline: Mon 8/7/2017

UCSD Layoff from Career Appointment: Apply by 07/10/17 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Eligible Disability Counseling and Consulting services (DCC) or Special Selection clients should contact their Vocational Rehabilitation Counselor for assistance.

DESCRIPTION

Perform standard laboratory procedures with Human Embryonic Stem Cells (hESC), neuronal precursor cells (NPCs), induced neurons (iNeurons), and mature neurons (mNeurons), and brain organoids.

Under supervision, Stem Cell Research Technician will work with PI and other lab members to refine protocols and to generate data from mutant cells for publication. Studies will include
1) General growth and maintenance of fibroblast and stem cell lines (adult and embryonic derived)
2) Gene manipulation of these stem cells with, CRISPR targeting, shRNA silencing or overexpression using transfection or lentivirus transduction
3) Characterization of resultant phenotypes by molecular and imaging techniques
4) Molecular biology techniques to isolate RNA and quantify gene expression.

Procedures will include molecular biology (generation of transgene constructs, PCR and RNA isolation) and microscopy as well as basic molecular and cellular biology techniques (Cell transfection, genomic screening, cloning, gene expression, immunocytochemistry, tissue culture and maintenance of biochemistry equipment).

Independently perform tissue culture of primary cells, preparation of lentiviruses and viral infection techniques, maintain tissue culture facility stocks and inventory, perform regularly scheduled mycoplasma testing, ship and receive cell lines for collaborations. Perform cell culture electroporation in stem cells and independently perform routine biology and biology techniques including next generation sequencing techniques. Other tasks as required by the supervisor and project scientists. Incumbent will also be involved with general lab organization procedures.

MINIMUM QUALIFICATIONS

  • Theoretical and/or practical knowledge in cellular and molecular biology, immunology, stem cell or related field as typically attained by a Bachelor’s Degree; or an equivalent combination of education and experience.
  • Demonstrated ability to perform molecular biology techniques including PCR, DNA preparation/extraction, gel electrophoresis, sterile technique.
  • Proven rated experience in performing biochemistry and laboratory techniques and demonstrated experience to prepare buffers, pH solutions, as well as various staining solutions.
  • Experience performing laboratory procedures with Human Embryonic Stem Cells (hESC), neuronal precursor cells (NPCs) and brain organoids.
  • Proven experience maintaining human embryonic stem cells, neuronal precursor cells, and hESC derived motor neurons in undifferentiated state.
  • Demonstrated experience generating lentiviral/retroviral culture medium for infection of hESCs, NPCs, and hESC derived motor neurons.
  • Demonstrated experience working with DNA, RNA, protein in preparation for next generation sequencing or proteomics analysis.
  • Experience with the operation of a personal computer and software such as Filemaker or other databases.

PREFERRED QUALIFICATIONS

A Bachelor’s Degree in cellular and molecular biology, immunology, stem cell or a related field.

SPECIAL CONDITIONS

  • Willingness to work with animals, lentivirus, radioactive material, embryonic stem cells, human tissue and standard hazardous laboratory compounds.
  • Ability to work evenings and weekends to maintain workflow.

Head, Clinical Operations

Job Title: Head, Clinical Operations

Job Number: 10917

Location: Cambridge, MA

Job Description

The Senior Director, Clinical Operations will be responsible for the oversight, management and delivery of clinical trials. Responsibilities include the execution of clinical development plans in collaboration with other corporate functions, line management for selected clinical operations staff, clinical outsourcing management, and financial and budgetary oversight of clinical trials. In addition, he/she will be responsible for strategic initiatives for process and business improvements, including executive level management, requiring negotiation of difficult matters, often related to contracts, work orders, and timelines.

Responsibilities

Duties & Responsibilities: • Provide a leadership role in conducting multiple Phase I–IV clinical research trials across all functional areas of the drug development process. • Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality are met. • Select CROs (and other vendors) and create contracts and/or work orders. Negotiate budgets and contracts with CROs, vendors, and investigator sites. • Review budgets, forecasts and accruals for clinical studies, and ensure that clinical projects remain on schedule and within budget. • Develop and review strategies for operational efficiencies. • Report on study progress, timelines, milestones, and challenges to the CMO. • Make recommendations for staffing needs. • Attend investigator meetings, kick-off meetings and various CRO or other vendor meetings. • Coordinate the on-schedule delivery of clinical trial supplies in collaboration with clinical supply vendors • With the CMO, assist in interviewing, hiring and training employees; planning, assigning and directing work; setting objectives; performance appraisals; rewarding and disciplining employees; addressing complaints and resolving problems. • Liaise with Regulatory Affairs and Quality to assure adherence to GCPs; maintenance of SOPs and assure site and CRO/vendor audits are completed. • Perform other duties as required.

Required Skills

Qualifications:
• B.S. Degree required; advanced degree preferred.
• >8 years of relevant industry experience in clinical/medical research or pharmaceutical/devices.
• >5 years leading Clinical Operations including direct oversight and management of employees.
• Extensive drug development experience in Phase I-IV, experience with biologics preferred.
o Hands-on experience must include Phase II and III studies and global/international studies or
programs; Multiple therapeutic areas required. Infectious disease and/or Gastrointestinal Disease
and/or Vaccine experience is highly desirable.
• CRO and vendor selection
• Study initiation procedures, including site feasibility and qualification
• Clinical supply management
• Clinical monitoring functions
• Regulatory Affairs and Quality, including GCPs, CFRs, SOPs, audits/inspections
• Data flow from sites to data processing, review and query resolution
• Analysis and report generation
• Data Safety Monitoring Boards (DSMBs)
• Project Management, including timelines and milestones
• Financial planning & analysis, contract negotiation/management, forecasting
• Willingness to do the ‘hands-on’ work, as needed, while the company grows.
• Proven track record of effective clinical operations management and leadership; Keen ability to lead
and motivate a clinical team.
• Demonstrated ability to lead people and manage staffing, budgeting, and clinical operations,
including collaboration and problem-solving with project teams, CROs, and vendors.
• Superb understanding of regulatory compliance requirements for the conduct of clinical trials, both
in the US and abroad.
• Ability to quickly learn and apply new skills, meet short deadlines, and multi-task, in a fast-paced
biotech environment.
• Deep experience in data management, statistics, project management, and related disciplines, to the
extent necessary for successful study execution.
• Excellent verbal and written communication skills, including a positive and professional attitude.
• Ability to handle multiple tasks to meet short deadlines in a dynamic environment, including the
rapid translation of operational strategies into clear objectives and deliverables.
• Strong organizational and leadership skills, and a willingness to work within a team-oriented
environment.
• Must be able to travel up to 20% of time on average.