The incumbent will be responsible for the design, implementation, and execution of a Clinical Development & Medical Affairs program for specific indications for a new technology that serves as an aid in the diagnosis of cancer.

Major Responsibilities will include:

• Strategic planning for assay development in a specific indication (e.g., Breast or Lung Cancer)

• Design and conduct of clinical studies for assay validation

• Preparation and review of written documents: Clinical Study Protocols, Case Report Form, Clinical Study Reports

• Interactions with key individuals on the assay Development Portfolio Management Team

• Preparation of documents for submission to regulatory authorities (e.g., Meeting Packages, Pre-Market Approval application, & clinical components of other regulatory correspondence)

• Participation as clinical expert in the evaluation of early discovery biomarkers or early stage external assets for their potential to be successfully candidates for new assay development

• Clinical oversight and direction of post-marketing studies

Essential Functions:

• Ongoing thorough and up-to-date knowledge of therapeutic areas of assets for development, including trends and competitive clinical landscape

• Close collaboration with Discovery Research, Statistics & Bioinformatics, and other disciplines within the company

• Interaction with Medical Affairs, Discovery research, and the Commercial group to achieve optimal target product profile for diagnostic assays in development and to achieve optimal commercialization of approved diagnostic assays

Minimum education requirements MD:

• Experience required 10+ Years

• Knowledge & skills (general and technical)

• Background in clinical research including, ideally to include randomized clinical trials, observational studies, & diagnostic assay validation studies

• Prior experience in clinical study design in industry or a focus on clinical research in academic medicine is desirable

• Knowledge of FDA regulations regarding evaluation and approval of new technology with an understanding of evolving requirements for new diagnostic assays

Other requirements (licenses, certifications, specialized training, physical or mental abilities required):

• MD or DO from an accredited Medical School

• Prefer: US Board Certification in Internal Medicine; Internal Subspecialty Training & Certification a plus in areas such as Pulmonary Medicine, Gastroenterology or similar

To apply: Please email ruth@pharmacruiting.com

The incumbent will help in all phases of medical affairs, concentrating primarily in the activities necessary for a successful product roll out. Responsibilities will include providing medical expertise on cross-functional teams, provide clinical support for the commercial organization, and building scientific relationships with internal and external experts. This role will be pivotal for planning and participating in launch readiness and launch-related activities, and evaluating new pipeline opportunities with the business development group.

Primary Responsibilities

• Working with key opinion leaders regarding messaging, slide training, speaker preparation.

• Helping with multiple clinical trials, including protocol design, medical/product questions, liaising with sites regarding trial issues, connecting with finance regarding payment issues, and working with internal and external contacts regarding abstract and manuscript preparation.

• Representing company as an external expert, meeting with key constituents (KOLs, insurance representatives, advocacy groups, etc.), delivering talks at major meetings and medical centers.

• Serving as an internal resource for the company both as a product content expert and resource regarding clinical oncology issues.

• Acting as a key member of the “commercial team” regarding product placement strategy, design issues, educational initiatives, and overall strategies to gain maximum product uptake and reimbursement.

Requirements

• MD with oncology training

• 1-3 years of experience in a biotech or pharmaceutical company, ideally on the Medical Affairs side. Research and Development experience acceptable. Oncology experience required.

• History of working in a “business” organization with shared responsibilities, well-recognized reporting structure and defined responsibilities

• Excellent presentation skills and ability to present complex data effectively in one on one, small and large group settings

• Excellent interpersonal skills and the ability to build trusting relationships with key external customers

• Ability to understand and interpret complex data sets

To apply: please email: ruth@pharmacruiting.com

Pharma-Cruiting Life Sciences Executive Search is seeking a Chief Operating Officer for our clinical reference laboratory in the Greater New York area.  The incumbent will be fully responsible for the performance and operations of  the clinical lab.  This includes all aspects of the day to day operations, P&L, technical aspects, sales, finance, contract negotiations, managed care plan negotiations, budgeting, customer service, information technology, administrative affairs as well as delivering significant growth with increased net profit margins and launching of new service offerings.

 Essential Duties & Responsibilities  

 * Overall strategic and tactical operation of the clinical laboratory.

 * Accountability for the service levels to achieve customer satisfaction and maintain productions and specified turnaround targets.

* Continuously monitor each department and ensures optimum staff levels to achieve standards of production, quality and financial performance and implementing improvements to ensure the laboratory achieves competitive advantage and profitability.

* Continue to develop the lab into a molecular and esoteric center of excellence.

 *Provide vision and direction to expand beyond existing markets in developing and monitoring  new services/products and concepts for various market segments.

 * Achieve and exceed key operational KPIs and maintain high quality standards and accountable for achieving the budget in terms of revenue and local contribution.

 *Act as the face of the lab in the marketplace and healthcare community.

 *Partner with sales teams and meet with medical professionals/customers to determine opportunities and technical requirements by promoting the image, capability and integrity of the lab.

 Ensure client service team continuously maintains a close working relationship between the laboratory and the medical professionals.

 Responsible for approvals and consumables management & timely ordering of supplies.

Requirements:

University degree in a science related field (Pharmaceutical, Chemistry, Life Science) with an advanced degree or MBA. M.D. preferred.
Accomplished inspirational visionary/leader with 10 + year experience in a general management role with operational expertise in a clinical laboratory.

 A results oriented senior executive with a proven track record and deep understanding of all the operational ins and outs of a complicated lab services business including finance, technical aspects, sales and customer service.

A strategic and tactical hands-on executive with strong analytical acumen who can think on their feet, continually strives for improvement of business processes and people performance to ensure revenue and profitability goals. 

 An exceptionally strong motivational leader capable of driving goals at the same time as fostering a corporate culture of commitment.

 A true people person capable of interacting with a diverse group of people and different personalities all levels of management, employees, suppliers and clients while driving growth..

 Business minded, team builder, competitive and profit driven (P&L experience) with related technical knowhow and ability to motivate towards a common goal.

 Ability to realize business opportunities in conformity to business strategy.

Superb attention to detail and follow-up with the ability to manage and coordinate teams and projects in a fast paced professional environment.

An exceptionally bright and articulate communicator with strong negotiation and interpersonal skills.

 The ideal candidate will come from a larger clinical lab and also have operational experience in a smaller more specialized lab. Oncology experience a plus.

 To apply: Please email ruth@pharmacruiting.com

 Pharma-Cruiting Life Sciences Executive Search is seeking a talented and highly motivated COMPUTATIONAL BIOLOGIST to develop, optimize, and implement data analysis pipelines and analytical tools that enable comprehensive tumor genomic profiling as a diagnostic product.

 Primary Responsibilities

 Work with a group of bio-informaticians, molecular biologists and software engineers focused on using massively parallel sequencing technology to characterize genetic alterations present in tumor genomic DNA and RNA

 Develop algorithms to identify mutations, chromosomal copy number alterations, and rearrangements in tumor DNA and RNA derived from clinical cancer specimens

 Develop and implement analytical tools enabling troubleshooting assay technical steps and filtering out poor quality sequencing information

 Work with the production team to develop scalable protocols that enable high-throughput interpretation of sequencing data for dozens of samples in parallel with minimal computational time/cost

 Monitor performance characteristics of published and emerging analytical pipelines and mutation detection algorithms

 Process, analyze and interpret high volumes of data as part of internal and external collaborative scientific studies. Develop automated methods and software to support large-scale bioinformatics analysis

 Monitor and evaluate analytical avenues for new/emerging sequencing technologies

 Present scientific and technical data/progress/innovations to both internal and external scientific colleagues in a clear and cohesive manner.

 Work independently and prepare timetables, deliverables, and project schedules

Requirements

 Ph.D. in Bioinformatics, Computational Biology, Computer Science or related fields

 Fluency in programming and scripting languages is required (C++, Java, Python, Perl)

 2-3 years of industry experience. Equivalent post-doctoral experience will be considered.

 A track record of achievement in the academic setting

 Experience in developing algorithms for analysis of biological data. Experience in algorithm development for analysis of massively parallel sequencing data (DNA-seq, RNA-seq) is required.

 Experience in cancer research, including a working understanding of computation approaches for cancer genome analysis, is highly desirable

 Strong scientific understanding of molecular biology and genomics

 Ability to work in a multidisciplinary, fast-paced, dynamic and results-oriented startup environment

 Ability to present data to a multidisciplinary audience in a clear and cohesive manner

 Excellent teamwork, time management and organizational skills are required

 To apply: Please email ruth@pharmacruiting.com

Pharma-Cruiting Life Sciences Executive Search is seeking a talented and highly motivated VICE PRESIDENT, BUSINESS DEVELOPMENT for our oncology personalized medicine client in Boston.  The incumbent will lead or assist in multiple aspects of business development and strategic planning.   

Reporting to the Chief Operating Officer, the successful candidate will be responsible for initiating, evaluating and negotiating business opportunities that are consistent with our client’s strategic partnership plan.  In addition s/he will: determine and recommend optimal deal terms ensuring optimal terms and conditions are achieved based upon commercial, scientific and financial analysis, prior to the negotiation of suitable terms and the close of each transaction; commission and project manage the evaluation of opportunities with colleagues in R&D, finance, legal and operations; build and maintain effective working relationships both internally and externally; lead or participate in screening for selected projects/collaborations; present at selected conferences in order to raise our client’s profile as a partner of choice; lead and grow the Business Development group in a manner that is aligned with our client’s standards of excellence.

In addition to providing the leadership/motivation, strategic vision, operational excellence and functional expertise that the Company requires to lead the cancer molecular diagnostic market, the VP, Business Development’s role focuses on the following initiatives:

Primary Responsibilities

• Drive the identification, pursuit, negotiation and closing of key deals with prospective Pharmaceutical, oncology and diagnostics companies

•  Develop proposals and term sheets for prospects and lead critical aspects of closing, including creation of financial models, integration of legal counsel, and coordination with other functional areas
• Direct the evaluation and development of strategic partnerships, joint ventures and alliances, as well as technology and intellectual licensing opportunities with industry, academia and government agencies, including interaction with existing and new corporate contacts
• Serve as primary contact person for external partnerships. Work with internal team to maximize relationship potential
• Development of the Value Creation Plan
  • Assist management team in the development of the value creation strategy and business strategy
  • Scenario planning, modeling and analysis
  • Prepare the analytical preparatory work and provide diligence support for transactions (examples could include comparable deal analysis, financial modeling and simulations, NPV analysis, preparing and setting up diligence files, financing documents, etc.)
  • Lead/co-lead partnership discussions
  • Lead efforts to obtain non-dilutive financing
  • Negotiate MTA’s
  • Lead detailed diligence for partnership and M&A activities, as necessary.
  • Work with Operations to upgrade existing service provider agreements when possible to larger, more inclusive strategic deals with a primary goal of our client obtaining unique content or exclusive terms to deploy unique content and increased revenue streams that are milestone based

• Track milestones and identify scope for enhancing relationships. Manage, analyze and report on the status of all prospects in the business development pipeline

 Requirements

• 10-15 years of relevant, post graduate,  life sciences industry experience in addition to a background in science and with an aptitude to quickly understand new science and technology; oncology experience is preferred
• Experience is the Diagnostic industry is a benefit but not a requirement; however, an understanding of the role diagnostics play in cancer therapeutic development is essential
• Prior experience with corporate partners and in prospecting, negotiating and completing deals and managing external collaborations. A deal sheet demonstrating experience with “sell side” transactions will be required

• Substantial experience networking and negotiating contracts with pharmaceutical and biotechnology companies as well as academia at the executive level, specifically within the drug discovery and development areas

• Demonstrated experience in identifying value creation opportunities and executing on a plan to ensure the value is capitalized on
• Exceptional oral presentation and written communication skills, as well as demonstrated ability to foster and maintain positive professional relationships within the life sciences community

• Demonstrated analytical and financial modeling capabilities
• Ability to work collaboratively with many different internal and external constituencies

• Demonstrated ability to create and champion new ideas and influence senior management

• Detail orientation, sense of urgency, hands-on professional style and high level of competency directly implementing successful business strategies from existing and new partnerships

 To apply: Please email cover letter and resume to ruth@pharmacruiting.com

Pharma-Cruiting Life Sciences Executive Search is seeking a Finance Director for a global pharmaceutical company in Moscow. 

The Financial Director is responsible for planning, directing and controlling financial resources by following policies and procedures in accordance with Federal and Territorial legislation.

The Financial Director reports directly to Head of Representative Office and is responsible for managing financial functions. This includes: preparing the budget; conducting financial analysis and preparing financial reports; developing and implementing an effective system of accounting; managing the payroll system and maintaining accurate and current bylaw records.

 RESPONSIBILITIES

 -         Financial resources planning

 -         Research, prepare and submit the annual budget and forecasts

 -         Prepare detailed reports on financial  matters, analyze of results of operating business

 -         Manage accounting and financial systems and maintain full and accurate accounting records

 -         Optimize working capital through effective implementation and control of stock, trade debtors and creditors policies.

 -         Conduct financial analysis and prepare detailed financial reports and statements

 -         Provide financial and accounting advice, direction and leadership

 -         Develop and implement purchasing practices and monitor the purchasing system

 -         Prepare tender documents and administer contracts

 -         Respond to auditors’ comments concerning finances and operations and oversee required action to address deficiencies

 -         Implement and monitor payment authority practices

 -         Monitor the business process and advice in changes to maximize gross profits and margins, reduce costs, control assets maximizing returns on each asset and improve efficiency and compliance with corporate standards. 

 -         Establish and maintain cash controls

 -         Manage investments and reserves, optimize costs, manage business risks

effectively.

 -         Manage the maintenance and upgrade of financial, payroll information systems

 REQUIREMENTS

 -         Understanding highly complex fiscal compliance issues across the Organization and working as part of an International group that demands high performance for staff to contribute across wide range of areas

 -         Must have the ability to work at pace across a wide range of concurrent issues while developing and maintaining a high performance finance team

 -         Possess Bachelor’s Degree, MBA preferred

 -         10 years of demonstrated progressive financial management experience

 -         Fluent in English

 To apply: Please email cover letter and resume in English to ruth@pharmacruiting.com

The ideal candidate will have a Ph.D in Pharmaceutics or Pharmaceutical Sciences

Experience required:

• US regulatory expertise in Novel Drug Delivery Systems (NDDS), Devices and Biosimilars.

• Approximately 20 – 25 years experience in Pharmaceutical Industry with at least 10 –15 years experience in Regulatory Affairs.

• Proven capability of providing direction to a group of 45-50 Scientists /Managers.

• Should have good contacts with US FDA personnel • Should be able to handle Plant audits with team.

• Should have capability to manage and interact overseas team while based in US.

• Knowledge of IP, new technologies, Para IV product filings and 505 (b) (2) filings.

Please email ruth@pharmacruiting.com to apply

Pharma-Cruiting Life Sciences Executive Search is seeking a VP, Information Technology (VP) for our oncology diagnostics client.  The ideal candidate will be a dynamic and broad information technology expert with a minimum of 10 years of experience leading best in class information technology functions, preferably within a diagnostic service company.

As a member of the management team, the VP is expected to:  work with leaders across the organization to ensure that IT has a role within all major strategic initiatives both with respect to enterprise computing and scientific computing and that the value of IT consultancy is broadly recognized across the organization.  The successful individual will build, deliver, guide, and maintain a strong IT strategic plan and architecture in order to align the information technology portfolio with various departmental needs and the overall business strategy; lead and grow the Information (IT) Technology team within the Company and manage the members of the IT team to deliver results and perform at a level that is aligned with our clients standards of excellence. 

In addition to providing the leadership/motivation, strategic vision, operational excellence and functional expertise that the Company requires to lead the cancer molecular diagnostic market, the VP, Information Technology’s role focuses on the following initiatives:

• ·         Corporate IT -
  • o   Desktop & Networking –  Oversight, strategic planning,  support, and maintenance of corporate systems including, but not limited to the email platform, antivirus, back-up systems, wireless systems, hardware and software improvements, VPN, laptops/desktops, office and mobile phones, and all ancillary office systems;  provide front line customer service for employees’ technology needs; establish and operate a highly efficient rapid response program for incident and troubleshooting management, and ensure up to date access to automation, hardware, and software tools to improve team productivity and efficiency; perform daily system monitoring, verifying the integrity and availability of all hardware, server resources, systems, and key processes by reviewing systems logs and ensuring the completion of scheduled jobs such as backups; troubleshoot network performance issues and create and maintain a disaster recovery plan; ensure the company has an available, reliable, up to date, and efficient IT infrastructure

• o   Security – Define, plan, and implement security technology that meets corporate and industry required security guidelines while meeting compliance with a range of regulatory and legal requirements, including SOX, HIPAA, CLIA, CAP, FDA, and state laws; guide, configure and manage the utilization of vulnerability assessment tools to monitor intrusion detection and provide the means for determining security exposures of computer systems and networks; advise and consult with all management levels on IT Security risk management matters that enable sound business growth and protection; assess severity levels of security threats and coordinate the appropriate notifications or escalations in a timely manner and develop the required corrective measures

• ·         Storage – Oversee all components of managing data storage capacity and provide appropriate scalability and colocation capabilities as data accumulates.  Demands are anticipated to be large scale and complex both within the corporate/enterprise computing domain and the clinical and scientific computing domains.  Data storage, data accessibility, data transfer and data management needs are anticipated to be required not only within the internal organization but also between client organizations.
• ·         LIMS – Oversight and complete responsibility for the LIMS/LIS system including; assessment and complete understanding of various departmental needs emphasizing data tracking and workflow continuity between departments; offering enhanced workflow and data tracking support for all aspects of product evolution from development, through validation and scale-up and transfer into a production environment; maintain flexible architecture that can bend and grow with company, product and technology evolution; ensure smart data exchange interfaces; maintain an in depth knowledge of how to fully support LIMS/LIS systems in increasingly regulated environments (e.g., CLIA, HIPAA, GLP, and FDA QSR specification); ensure adaptation to many different high complexity, high content, assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance.
• ·         Automation – Oversee the effort to define requirements and specify and implement IT integration solutions for automation platforms selected for company medium to high throughput sample preparation and sequencing service pipeline; maintain broad exposure to commercially available liquid and plate handlers as well as custom platforms, in a high throughput, high complexity clinical genomics testing environment.
• ·         Process Monitoring- Help design, build and support the computational and database infrastructure necessary to enable routine data acquisition and statistical analysis for continuous clinical laboratory process monitoring and process improvement.    Interface with the process engineering function to enable analyses of process metrics that ensure uninterrupted delivery of highest possible quality patient results within specified turn around times with a minimum of downtime.
• ·         Informatics – Support and coordination of efforts for the Knowledgebase and user interface.

To apply: Please email resume and cover letter to ruth@pharmacruiting.com

The incumbent will be responsible for building out their IT Department comprising of CLIA and R&D Lab operations, corporate and enterprise systems as well as Medical Informatics.  Ideal candidate will have senior level IT diagnostics experience in a high throughput lab. Must have held a similar position previously and have experience in the following areas: 

 Lab Automation, LIS Admin, Desktop Management, Networking, Storage, Security as well as developing User Interfaces and Informatics knowledgebase. Experience also with CAP, NYS, FDA and ideally GLP.

Please email ruth@pharmacruiting.com for more details.

 Responsibilities: 

• The incumbent will be responsible for establishing a team and laboratory equipped with specific infrastructure to handle Parenteral NDDS projects. 
• Developing generic equivalents of Depot Delivery system for advanced markets. 
• Exploration and development of new Depot/Targeted Drug Delivery leads in collaboration with renowned research institutes (NIPER, NII, CDRI etc.) 
• Exploration of new 505(b)(2) opportunities through NDDS route 
• Support in Business Development activities and evaluation of novel formulations for in-licensing. 

 Requirements: 

• M. Pharm / Ph. D in Pharmaceutics or Pharmaceutical Sciences 
• 10 – 15 years experience in Pharmaceutical Industry with at least 5 years experience in Parenteral  NDDS product
• Proven capability of developing such products / handling the technology
•  Experience in development and technology transfer of Sterile products

 To apply: Please email ruth@pharmacruiting.com