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Career postings for the Massachusetts Biotechnology Council

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    The Director, Early Development in Global Medical Affairs will assist with the strategy and medical support for Vertex compounds in early development. He/she will work closely with a cross-functional group that includes Research, Clinical Development, Commercial, Health Economics and Outcomes, and Corporate Communications. This person must have the ability to work effectively in a highly matrix environment and have a successful track record of developing project strategies and executing project details.  He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.

    General Responsibilities and Required Skills:

    ·   Provide medical affairs input into the early development programs/activities and execute the medical communication plans for these programs

    ·   Work cross functionally and partner with other key functions at Vertex such as Clinical Development, Commercial, Health Economics and Outcomes, Research and Regulatory to provide input into the clinical development, commercialization and life-cycle management plans for products in early development

    ·   Partner with Thought Leaders and other external groups to gather information on current therapeutic area issues and early clinical development trials


    Key Responsibilities:

    ·   Develop scientific communication platforms for early development compounds with cross-functional team members including mechanism of action scientific stories, scientific platforms and publication plans

    ·   Work with cross-functional teams to development internal and external communication plans for early development programs

    ·   Provide medical support to clinical trial investigators in collaboration with clinical development and operations

    ·   Develop global external engagement plans (including Thought Leaders) for early development programs that expand during clinical development

    ·   Lead the development of content for advisory boards and summarize key takeaways from the meetings with cross-functional team members

    ·   Conduct medical reviews of advisory board content, medical education projects and medical information responses

    ·   Provide guidance on HCP, patient and payer needs and promote medical differentiation of products

    ·   Contribute to the clinical development, commercialization and life cycle plans for early development compounds

    ·   Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for early development compounds and competitive landscape

    ·   Leverage medical expertise and research knowledge to support Regulatory strategies and product labeling

    ·   Provide medical input and product expertise to Medical Information group

    ·   If required, manage or mentor staff within Medical Affairs

    Position Qualifications:

    • PharmD/PhD/MD with a minimum of 7 years of pharmaceutical industry experience
    • Possesses knowledge of drug development process
    • Experience in medical affairs in working in a therapeutic area/medical director role and interest in the neurology and oncology therapeutic areas (experience in these areas is a plus)
    • Broad understanding of Global Medical, Regulatory and Commercial environments
    • Experience with managing external agencies and project timelines/budgets
    • Demonstrated ability to build alignment through strategic partnerships
    • Excellent written and oral communication skills
    • Ability to work in a fast-pace and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
    • Ability to manage tight deadlines and project budgets in a changing, fast pace environment
    • Demonstrated ability in driving results to a positive outcome. The ideal candidate will have a track record of delivering outstanding results
    • Proven ability to develop internal relationships in a highly matrix environment, as well as external relationships with Thought Leaders and industry experts
    • Possess understanding of government and industry guidelines, regulations, laws, etc. for appropriate scientific/medical exchange and communication with customers

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    Position Responsibilities:

    The Principal Clinical Data Manager manages cross-functional CDM study teams and coordinates Clinical Data Management activities within multiple studies. The Principal Clinical Data Manager oversees multiple complex studies. The Principal Clinical Data Manager is recognized as an internal expert in all areas of CDM processes and systems

    Key Responsibilities:

    - Defines and manages CDM project timelines on multiple complex studies or programs

    - Responsible for all the CDM study deliverables, evaluates and mitigates risks across program/s

    - Responsible for study and/or program resource planning

    - Assists in establishing CDM vendor management strategies for a program

    - Reviews vendor RFIs, RFPs, proposals and contracts, and provides input

    - Leads innovation and implementation of new technologies resulting in process improvements

    - Participates in and may lead cross-functional process initiatives

    - May supervise other Clinical Data Management staff - Performs other duties as assigned

    Technical and Communicative Skills:

    - Proven ability to independently determine the most appropriate methods and procedures across Clinical Data Management projects

    - Displays highly-evolved writing and oral presentation skills that enable him/her to disseminate the importance of complex findings articulately and persuasively

    - Possesses highly advanced knowledge of CDM and all relevant disciplines related to the drug development process

    - Recognized as an emerging mentor

    Position Qualifications:

    - Prefer B.S. (or equivalent degree) in a scientific or allied health field (or equivalent degree)

    - 6-8 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background


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    Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways.

     

    This 6+ month contract assignment will focus on providing clinical pharmacology expertise for assigned projects. He or she will also assist in the design, execution, and analysis of clinical pharmacology studies. This person will have the opportunity to work/assist on clinical pharmacology sections of New Drug Application.

      Responsibilities:
    • Provide clinical pharmacology input into regulatory documents
    • Contribute Clinical Pharmacology strategy for assigned program(s)
    • Perform or oversee PK and PK/PD analyses using standard PK software tools
    • Prepare, review and deliver scientific presentations for internal/external use 
    • Ensure constructive collaboration with the project team and external business partners
    • Maintain current clinical pharmacology knowledge
     Qualifications:
    • MS/Pharm.D./Ph.D degree or equivalent experience
    • 2-6+ years of Clinical Pharmacology experience; 2+ years of total biotech/pharmaceutical or related industry experience preferred
    • Experience and/or in-depth knowledge of pharmacokinetic tools (e.g., SAS/R/Splus, WinNonlin)
    • Extensive experience with Microsoft Word, Powerpoint, Excel
    • Strong knowledge of related disciplines (e.g., DMPK, Oncology, translational medicine, biostatistics, toxicology, regulatory) in the drug development process
    • Strong critical thinking and problem solving skills, including publications/presentations 
    • IND & NDA submission

    To apply, please visit our website at http://www.infi.com


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  • 12/22/15--08:00: Medical Director
  • The Medical Director will serve as the Medical Lead for Vertex clinical trials in Cystic Fibrosis, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials in Phases 1 through 3 and may also participate in selected projects in the Cystic Fibrosis clinical development program.
     

    Key Responsibilities:
    •    Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
    •    Serves on cross-functional Study Execution Teams (SET) for
    assigned trials, working with other team members to achieve efficient,
    high-quality study execution
    •    Participates in the preparation of regulatory documents in support of regulatory submissions,  including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
    •    Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
    •    Acts as liaison between Clinical Development and other internal
    groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies
    •    Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
    •    Performs other duties as assigned related to Cystic Fibrosis clinical programs

    Minimum Qualifications:
    •    MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background in a clinical field)
    •    Board Certification/eligibility in pulmonary or gastrointestinal medicine, or another relevant medical field, is highly desired; clinical Cystic Fibrosis experience is a plus
    •    At least 5-8 years of basic or clinical research experience in
    an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
    •    Excellent oral and written communication skills
    •    Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate

    Preferred Qualifications:
    • Global clinical research experience and experience interacting with regulatory authorities

     


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  • 12/22/15--08:00: Senior Associate, CMC
  • Purpose

    Performs the coordination and preparation of document packages for regulatory submissions, responses and/or audits and inspections;  compiles materials required in submissions, labeling, marketing material, license renewal and/or annual registrations;  may coordinate changes for labeling, manufacturing, marketing and protocols for regulatory compliance. Support global regulatory CMC aspects for assigned projects/products.  Provide regulatory CMC support to key business initiatives related to product development and life-cycle management of LMI’s product portfolio.  Keeps abreast of regulatory procedures and changes.  With direction, may initiate interactions with regulatory agencies on defined matters.    

    Essential Functions

    • Manages focused regulatory projects to ensure regulatory issues are addressed and submissions are reviewed and approved  to meet project target dates.
    • Reviews Technical Operations, and Development documentation for regulatory compliance; including validation protocols, close out reports, analytical methods, batch records and any other CMC related documentation.
    • Executes compilation of pre- and, post-approval regulatory submissions including annual reports, renewals, supplemental applications, amendments and other maintenance dossiers.  Coordinates appropriate submission timelines and manages regulatory submission authoring and review cycles to meet business initiatives. Coordinates the drafting and review of responses to global health authority questions and comments.
    • Supports global regulatory strategy related to CMC for life cycle maintenance of marketed products and product development for pre-market programs.
    • Collaborates with International Commercial team to support LMI commercial products and to maintain current registrations to support the international market.
    • Collaborates with other functional work teams and team members, both internal and external to the company, e.g., Preclinical, Clinical, Medical Affairs, Manufacturing, Technical Operations and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory submissions materials and to ensure regulatory documentation meets project target dates.
    • Acts as regulatory specialist on cross-functional team processes.  Serves on a range of cross-functional team processes (i.e. process and document change controls, investigational review team, etc.), providing current regulatory perspectives and considerations.
    • Support labeling coordination, including initiation and tracking revisions, for products in the U.S. and worldwide.  Support maintenance of product labeling files, electronic and other systems.
    • Maintains current regulatory CMC knowledge and provides a current knowledge of regulatory perspectives and considerations to a range of internal functional work teams.
    • Maintains current knowledge of, and ensure all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
    • Collaborates with other product Regulatory specialists to assure global CMC compliance for all product offerings.
    • With supervision, may interact directly on focused issues with the FDA and with other Health Authorities through local regulatory managers.
    • Actively promotes safety rules and awareness.  Demonstrates good safety practices at all times.  Reports and takes initiative to correct safety & environmental hazards.
    • Communicates effectively across all functional departments, organizational levels and externally to key stake holders including FDA, international health authorities and international marketing distributors as necessary.
    • Actively demonstrates the Lantheus values of accountability, quality, customer service, efficiency, collaboration and safety.

    Typical Minimum Skills and Experience and Education

    • BS/BA degree in a scientific discipline with a minimum of 5+ years of experience in a pharmaceutical industry or related GMP environment, or equivalent.

    Other Requirements

    • Non-routine travel based on business need.

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  • 12/22/15--08:04: Therapeutic Head, Liver
  • If interested and qualified, please include job code 2015-116 in the subject line when emailing resume to: careers@crisprtx.com.

     

    Reporting to the Senior Vice President, Head of Research, the incumbent will play a key scientific leadership role at CRISPR Therapeutics.  He/she will be responsible for directing programs in the development of liver disease therapies from early exploratory biology through positive Proof-of-Concept (POC). The successful candidate will be a driver of innovation and scientific excellence, identifying and advancing the best novel therapeutic hypotheses, targets and molecules.  Will partner with other disciplines of integrated drug discovery and development to build a strong pipeline of clinical candidates with strong/ clear rationale for differentiation from standard of care.  Will deliver highly competitive "Proof of Concepts".  

     

    Responsibilities

     

    • Provide key scientific oversight and strategy into the design, execution and analysis of liver disease studies
    • Build, manage and inspire a strong research team dedicated to liver disease therapies
    • Deliver a sustainable, highly competitive pipeline from target-to-POC
    • Work with CRISPR Therapeutics’ scientific leaders to leverage emerging technologies to provide better, faster and cost effective methods of applying translational medicine in liver disease research.
    • Support the Company’s business development team to improve/promote the Company’s value proposition in the Liver disease area.  
    • Ensure the B/D team is able to communicate the value of scientific assessments to potential clients/partners.
    • Publish articles/abstracts in key journals, and development/delivery of presentations to support meetings and grow medical/scientific credibility
    • Participate with other scientific leaders to plan company strategy around implementing new innovations and study designs.
    • Serve as a role model to colleagues by maintaining the highest standards of scientific rigor and ethical principles. Nurture a culture that promotes challenging and respectful interactions among colleagues and external collaborators

     

    Minimum Qualifications

    • PhD in a related discipline: 8+ years experience, preferably in liver biology research
    • High level of understanding of, and experience with, the drug development process
    • Strong management and planning skills in order to work with drug development projects/teams
    • Experience leading multi-functional work groups or teams.
    • Excellent oral and written communication skills.
    • Excellent organizational skills.

    Preferred Qualifications

    • PhD in Molecular/Cell Biology with 10 years’ research in liver disease
    • Industrial experience highly preferred

     

    Competencies

    1. Building a Successful Team– Building an effective group that contributes to the larger success of the organization through setting clear expectations, providing context and building commitment.
    2. Coaching– Providing an effective balance of support and direction to help another person achieve a defined goal.
    3. Decision Making - The ability to make sound decisions using judgment by evaluating all factors involved and potential impact.
    4. Leadership– The ability to take the role as a leader of a team or work group; the desire to lead others.

    Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

    Company Overview

    CRISPR Therapeutics is a biopharmaceutical company created to translate CRISPR-Cas9, a breakthrough genome-editing technology, into transformative medicines for serious human diseases. We are uniquely positioned to translate CRISPR-Cas9 technology into human therapeutics, thanks to our multi-disciplinary team of world-renowned academics, clinicians and drug developers.

    CRISPR Therapeutics’ vision is to cure serious human diseases at the molecular level using CRISPR-Cas9. The company is headquartered in Basel, Switzerland and has operations in and Cambridge, Massachusetts.

    Investors

    Investors in CRISPR Therapeutics include SR One, Celgene Corporation, New Enterprise Associates, Abingworth and founding investor, Versant Ventures.

    For more information, please visit www.crisprtx.com

    If interested and qualified, please include job code 2015-116 in the subject line when emailing resume to: careers@crisprtx.com.

     

     

     


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  • 12/22/15--08:05: Therapeutic Head, Liver
  • If interested and qualified, please include job code 2015-116 in the subject line when emailing resume to: careers@crisprtx.com.

     

    Reporting to the Senior Vice President, Head of Research, the incumbent will play a key scientific leadership role at CRISPR Therapeutics.  He/she will be responsible for directing programs in the development of liver disease therapies from early exploratory biology through positive Proof-of-Concept (POC). The successful candidate will be a driver of innovation and scientific excellence, identifying and advancing the best novel therapeutic hypotheses, targets and molecules.  Will partner with other disciplines of integrated drug discovery and development to build a strong pipeline of clinical candidates with strong/ clear rationale for differentiation from standard of care.  Will deliver highly competitive "Proof of Concepts".  

     

    Responsibilities

     

    • Provide key scientific oversight and strategy into the design, execution and analysis of liver disease studies
    • Build, manage and inspire a strong research team dedicated to liver disease therapies
    • Deliver a sustainable, highly competitive pipeline from target-to-POC
    • Work with CRISPR Therapeutics’ scientific leaders to leverage emerging technologies to provide better, faster and cost effective methods of applying translational medicine in liver disease research.
    • Support the Company’s business development team to improve/promote the Company’s value proposition in the Liver disease area.  
    • Ensure the B/D team is able to communicate the value of scientific assessments to potential clients/partners.
    • Publish articles/abstracts in key journals, and development/delivery of presentations to support meetings and grow medical/scientific credibility
    • Participate with other scientific leaders to plan company strategy around implementing new innovations and study designs.
    • Serve as a role model to colleagues by maintaining the highest standards of scientific rigor and ethical principles. Nurture a culture that promotes challenging and respectful interactions among colleagues and external collaborators

     

    Minimum Qualifications

    • PhD in a related discipline: 8+ years experience, preferably in liver biology research
    • High level of understanding of, and experience with, the drug development process
    • Strong management and planning skills in order to work with drug development projects/teams
    • Experience leading multi-functional work groups or teams.
    • Excellent oral and written communication skills.
    • Excellent organizational skills.

    Preferred Qualifications

    • PhD in Molecular/Cell Biology with 10 years’ research in liver disease
    • Industrial experience highly preferred

     

    Competencies

    1. Building a Successful Team– Building an effective group that contributes to the larger success of the organization through setting clear expectations, providing context and building commitment.
    2. Coaching– Providing an effective balance of support and direction to help another person achieve a defined goal.
    3. Decision Making - The ability to make sound decisions using judgment by evaluating all factors involved and potential impact.
    4. Leadership– The ability to take the role as a leader of a team or work group; the desire to lead others.

    Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

    Company Overview

    CRISPR Therapeutics is a biopharmaceutical company created to translate CRISPR-Cas9, a breakthrough genome-editing technology, into transformative medicines for serious human diseases. We are uniquely positioned to translate CRISPR-Cas9 technology into human therapeutics, thanks to our multi-disciplinary team of world-renowned academics, clinicians and drug developers.

    CRISPR Therapeutics’ vision is to cure serious human diseases at the molecular level using CRISPR-Cas9. The company is headquartered in Basel, Switzerland and has operations in and Cambridge, Massachusetts.

    Investors

    Investors in CRISPR Therapeutics include SR One, Celgene Corporation, New Enterprise Associates, Abingworth and founding investor, Versant Ventures.

    For more information, please visit www.crisprtx.com

    If interested and qualified, please include job code 2015-116 in the subject line when emailing resume to: careers@crisprtx.com.

     

     

     


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  • 12/22/15--08:52: Medical Director, Neurology
  • Vertex Pharmaceuticals is currently searching for an Associate Medical Director / Medical Director to join the Neurology Clinical Development team.  This Medical Director will assist with the clinical development for both early stage research compounds, providing clinical input to preclinical discovery teams, as well as clinical stage compounds.  The Medical Director will collaborate with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution, and will serve as Medical Monitor responsible for monitoring the safety of enrolled subjects in clinical trials from first-in-human studies, through later stage studies .

    Key Responsibilities

    • Develops clinical development plans, clinical study protocols, and investigator’s brochures in collaboration with cross-functional development teams, with a focus on the scientific, medical and safety aspects

    · Provides scientific and clinical input to other study-related documents, including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)

    · Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution

    • Serves as Medical Monitor for clinical trials, monitoring the safety of enrolled subjects, and ensuring compliance with GCP regulations

    · Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate

    · Provides medical leadership for data interpretation and compilation of final study reports

    • Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies · Ensures compliance with Vertex SOPs, ICH, GCP and other national and international regulatory requirements

    • Represents Vertex to outside medical/scientific experts in the development of the clinical protocols and solicitation of input and opinion, and presents at conferences and symposia in the neurologic area of interest

    • Performs other duties as assigned related to Neurology clinical programs

    Position Qualifications:

    • MD, MD/PhD or equivalent ex-US medical degree(s) and 3+ years of clinical research experience in industry or academics

    • Board certification in Neurology, Psychiatry or a related medical specialty. Clinical sub-specialization or experience in pain, neurodegenerative disease or epilepsy is highly desirable

    • Excellent oral and written communication skills · Working knowledge of GCP, scientific and clinical research methods and clinical study design

    • Understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics · Experience in filing and defending US IND's or similar ex-US regulatory submissions

    • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate


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  • 12/21/15--23:16: Administrative Associate III
  • The Administrative Associate III provides high level administrative support to the Clinical Development team in an efficient, professional manner. Responsibilities include stabling work flow priority based on assessment of tasks and consideration of interdepartmental needs. The work is generally non-routine in nature, and is performed using individual discretion under minimal supervision. The Admin Associate III interacts with both internal and external contacts to coordinate the accomplishment of departmental business needs.

    Key Responsibilities:

    Advance those of the Admin Associate II to include the following:

    • Prepares and processes departmental paperwork, including non-routine correspondence, complex presentations, and detailed reports requiring analysis of data

    • Initiates administrative procedures for department

    • Coordinates, schedules and manages travel, meetings, seminars series, speaking engagements and conferences for most senior members of department

    • May track and distribute updated "time-off" schedules

    • Handles details of a confidential and critical nature

    • Reviews and edits departmental documents for grammar, style and formatting

    • Ensures the accurate filing and tracking of all departmental documentation, including memos, correspondence, presentations and reports

    • Prepares reports and statistics based on information compiled from various sources on a regular basis

    • Prioritizes and manages manager’s schedule to include conferences, speaking engagements, travel, and daily meetings

    • Independently coordinates multiple on-going conferenced for departmental staff

    • Plans, schedules and coordinates departmental off-site meetings and events

    • Represents head of department and department staff to internal and external clients

    • Regularly interacts with internal and external contacts to coordinate department/manager business needs

    • May supervise other administrative staff

    • Performs other duties as assigned

    Communicative and Interpersonal Skills:

    In addition to those of an Admin Associate II:

    • Exercises independent judgment to optimize internal processes and procedures

    • Demonstrates excellent communication, verbal and written, and interpersonal skills

    • Demonstrates advances proficiency in Microsoft Office Suite

    • Provides guidance to more junior administrative staff

    • Displays ability to independently interpret policies and solve non-routine, complex issues

    • Possesses thorough understanding of departmental and company policies and procedures

    Position Qualifications:

    · H.S. Diploma, A.A, A.S., and 2-5 years of work experience in an administrative role · Bachelor’s degree. and 1-3 years of work experience in an administrative role


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    Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.

    Established as a wholly-owned subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a robust portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.

    Product Manager/Senior Product Manager, Global Marketing

    Reporting to the Director of Global Marketing, the Product Manager/Senior Product Manager, Global Marketing will be an integral member of the rapidly growing commercialization team, tasked with ensuring the successful global launch of volanesorsen (previously called IONIS-APOCIII-Rx) for the treatment of Familial Chylomicronemia Syndrome (FCS).

    This individual will be heavily involved in the pre-commercialization through launch marketing activities via the creation and implementation of key brand strategies. S/he will lead the development, execution and implementation of disease awareness and product launch activities to define FCS and differentiate volanesorsen in the minds of both health care professionals and patients. Specific activities include but are not limited to message development, creative campaign development, product branding development, market research and execution across print and digital channels. This role requires collaboration with cross-functional partners at Akcea and Ionis.

    Responsibilities:

    • Develop a global framework and lead US execution of pre-launch disease awareness and product communication strategies including:
      * Develop volanesorsen for FCS platform for HCPs and patients including positioning, segmentation, targeting, messaging and creative campaign.
      * Develop patient support services offering such as dietary support, subcutaneous injection support.
      * Understand needs/challenges of different geographic markets.
      * Develop and execute effective communication strategies for HCPs and patients that are clinically supported and aligned with brand tactics.
      * Develop and maintain effective collaborative working relationships with creative services/agency teams and internal colleagues. This includes the development of creative briefs, the routing of programs/tactics through the Commercial, Medical, Legal, Regulatory review process, and measurements of effectiveness
      * Effectively build budgets and manage external vendors accordingly
    • Lead pre-launch global naming and branding workstreams, including finalization of trade name, logo/branding, and packaging design
    • Execute market research and interact directly with customers to generate customer-based and market-based insights to inform strategic plans and tactics for volanesorsen & FCS
    • With cross-functional support, champion relevant training and education for internal and external customers to support launch
    • Contribute to development of Akcea marketing operations budget. Execution of assigned budget in a compliant fashion
    • Partner with cross-functional colleagues such as Patient Advocacy, Medical, Legal, Regulatory and Market Access in order to optimize and advance pre-launch disease awareness and product communication initiatives
    • Supports the team with patient perspectives and insights to ensure that Akcea’s focus on the patient is never lost

    Qualifications:

    • Bachelor’s degree in a marketing or science discipline; MBA or other advanced degree preferred
    • Minimum of 4+ years pharmaceutical marketing experience or equivalent analytical experience in related pharmaceutical function (market research, sales analytics, forecasting, etc.)
    • Successful track record of innovation and implementation of effective initiatives in a life sciences organization
    • Excellent analytical, planning and organizational skills
    • Superior communication skills (verbal, written and presentation skills)
    • Effective utilization of marketing research to optimize the launch of new products preferred
    • Skilled in data analysis and computer skills
    • Ability to effectively manage, coordinate and work on multiple projects simultaneously in a competitive fast-paced environment
    • Able to successfully adapt and navigate through changing priorities
    • Strong interpersonal skills with the ability to work effectively across levels, companies and teams

    Excellent salary and benefits package offered.
    Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #15-0115
    NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

    Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. are proud to be EEO employers.


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    Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  The focus of this position is to support the growth of the Cell Procurement group within bluebird bio.   We are looking for an innovative professional with the breadth of experience and drive to implement our vision for this function and work collaboratively with external partners.

    About the role:

    • Work with a multidisciplinary team that includes nurses, other care providers and non-clinical staff, as well as cross functional department staff to maintain an environment that is responsive to patient needs, encourages customer service, enhances efficiency and effectiveness, and promotes employee and patient satisfaction.
    • Manage the administrative and operational aspects of building a network of collection partners focused on apheresis, bone marrow, and whole blood collections.
    • Manage all business operations including budget development, contract administration, and collection site documentation.
    • Collaborate with the Supply Chain department to ensure traceability of whole blood and apheresis product for manufacturing. 
    • Collaborate with other stakeholder departments such as Quality Assurance to ensure that the cell procurement centers are compliant with all necessary regulations and company policies/procedures as applicable.
    • Develop cell procurement proposals for clinical trials to address state requirements, regulations and practices.
    • Develop strategic plans for scaling the procurement network to meet clinical and commercial forecasts.
    • Acts as an integral member of the department by leading and facilitating a collaborative environment between department personnel, partners (cell procurement sites), reimbursement coordinators, and other company departments.
    • Ensure consistency in collection procedures and manage any exceptions generated during the process.
    • Develop and report key metrics needed for managing the day to day apheresis activities and long term metrics required for strategic supply operations planning.
    • Create internal staffing requirements and skill sets required to support the nationwide apheresis network.
    • Conduct periodic assessments of collection facilities as needed.
    • Participate in additional GMP vendor management activities related to the network of bluebird contract manufacturers and testing labs.

     

    About you:

    • Bachelor's degree or the combination of education and business experience required - advanced degree preferred (e.g. MBA, MPH, etc.).
    • Minimum 8 years of healthcare or related experience, including management within teaching hospital or health systems, clinics or blood banks.  Oncology, urology, apheresis or leukapheresis preferred.
    • Experience managing satellite or contract healthcare sites is preferred.
    • Demonstrated excellent leadership, communication and presentation skills.
    • Experience analyzing and interpreting Apheresis economics/financial performance as well as developing scalable processes for a rapidly expanding network.
    • Good understanding of applicable regulations and standards (AABB, FACT JACIE)
    • Good understanding of GMPs and GCPs
    • Previous experience managing a function or team
    • Willingness to travel, domestically and internationally (up to ~25% of time)
    • Ability to execute and follow-through to completion and documentation.
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated, detail oriented and good problem solving ability.
    • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
    • Excellent communication skills and ability to influence across multiple functions.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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    GENERAL SUMMARY OF POSITION:

    Under the general direction of the Director or designee, the Associate Director Process Development is responsible for leading cell line, media, and bioreactor process development activities to optimize MAb production processes and define process parameters, limits and ranges. This position provides technical guidance and leadership to process development staff; manages upstream process development projects; prioritizes group tasks and manages resources in order to meet organizational and departmental goals.

    MAJOR RESPONSIBILITIES:

    • Leads a team of scientists and research associates to optimize monoclonal antibody production in large scale culture.
    • Provides technical and scientific guidance to team members.
    • Collaborates with and supports Manufacturing, Product Discovery, and other groups within the organization to meet organizational objectives.
    • Develops, scales up, and troubleshoots cell culture and primary recovery of monoclonal antibody products.
    • Designs experiments, analyzes data, and draws conclusions.
    • Ensures accurate and complete documentation of lab activities to ensure appropriate regulatory submission.
    • Writes technical reports for tech transfer and regulatory submission.
    • Evaluates productivity of cell lines, feed strategies, and process control parameters in bench-top bioreactors (1L) to pilot scale bioreactor (60L).
    • Ensures the production of material for preclinical and toxicology studies.
    • Develops media and feed formulations, optimizes bioreactor conditions, and demonstrates scalability of the processes.
    • Develops and implements new technologies to streamline cell culture process development and manufacturing.
    • Works with vendors to evaluate new technologies.
    • Implements QbD (quality by design) approaches and utilize DoE (design of experiment) and metabolic modeling to optimize processes.
    • Leads activities in bioreactor design, characterization, process monitoring and development of control strategies.
    • Manages tech transfer to clinical production at 2500L bioreactor, lead scale-up and troubleshooting activities.
    • Maintains substantial current knowledge of new technologies and innovations in the field of MAb cell culture and production.
    • Works with senior leadership team to maintain an environment that fosters teamwork, collaboration, and innovation.
    • Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.
    • Works on problems of diverse scope where analysis of situation or data requires a review of complex data.
    • Performs additional job related duties as required.

    REQUIRED QUALIFICATIONS:

    • Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 5 years of relevant experience.
    • Experience with large scale cell culture and bioreactor operations
    • Demonstrated potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
    • Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
    • Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
    • Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
    • Excellent problem solving skills as well as time management and organizational skills.
    • Proven ability to manage others, assign and schedule work, and conduct performance evaluations.
    • Able to travel as needed

     

    PREFERRED QUALIFICATIONS:

    • Previous experience in a cGMP environment
    • Experience with Design of Experiment (DOE) software



    Apply Here

    PI92572357


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    GENERAL SUMMARY OF POSITION:

    Under the general direction of the Director or designee, the Associate Director Process Development is responsible for leading Process Development analytical activities. This position provides technical guidance and leadership to Process Development staff; manages downstream process development projects; prioritizes group tasks and manages resources in order to meet organizational and departmental goals.

    MAJOR RESPONSIBILITIES:

    • Develop and troubleshoot assays for characterization of MAb and vaccine products.
    • Conduct preclinical stability studies and characterize degradation pathways.
    • Support upstream and downstream development with spent medium analysis and testing of in-process material.
    • Ensure accurate and complete documentation of laboratory activities, suitable for regulatory submissions.
    • Write technical reports for tech transfer and regulatory submission.
    • Lead the investigation and development of biochemical or biophysical assays that will be used in MAb formulation development, stability studies, and in-depth characterization of purified products.
    • Collaborate with and support Product Discovery, Quality Control and other groups within the organization to meet organizational objectives.
    • Provide technical and scientific guidance to team members.
    • Maintain substantial current knowledge of new analytical technologies and innovations that could be applied to MAb characterization.
    • Work with senior leadership team to maintain an environment that fosters teamwork, collaboration, and innovation.
    • Hire, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.
    • Work on problems of diverse scope where analysis of situation or data requires a review of complex data.
    • Perform additional job related duties as required.

    REQUIRED QUALIFICATIONS:

    • Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 5 years of relevant experience.
    • Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
    • Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
    • Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
    • Possesses strong attention to detail, the ability to maintain accurate records and excellent proofreading skills
    • Excellent problem solving skills as well as time management and organizational skills.
    • Proven ability to manage others, assign and schedule work, and conduct performance evaluations.
    • Able to travel as needed

    PREFERRED QUALIFICATIONS:

    • Previous experience in a cGMP environment
    • Experience with Design of Experiment (DOE) software



    Apply Here

    PI92572358


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  • 12/22/15--00:17: Research Tech - Senior
  • Job ID: 27485
    Date Posted: 12/18/2015
    Location: Building HIM
    Job Family: Technician/Technologist
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.


    Overview

    The Reinherz Lab is part of the Bill and Melinda Gates Foundation Consortium of Aids Vaccine Development. A research technician position is available immediately to study HIV vaccine immunology with the goal to modulate B cell selection and ultimately to elicit high affinity broadly neutralizing antibodies. We seek self-motivated candidates with B.S. or M.S. degree and experience in biochemistry, molecular biology, cell biology, and/or immunology. The successful candidate will participate in projects requiring technical expertise such as bacteria culturing, gel electrophoresis, western blot, PCR, cloning, mammalian cell culture and transfection, protein purification and characterization, flow cytometry, etc.

    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.



    Schedule

    Monday - Friday



    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.



    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.




    Apply Here

    PI92573149


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    Foundation Medicine (FMI) has developed a companion diagnostics business utilizing its Molecular Information Platform that enables biopharma partners to accelerate their drug development process and expand opportunities for their new medicines. FMI has an outstanding opportunity for a Director, Business Development (CDx) to partner with FMI leadership teams to develop and implement strategies for the expansion of the companion diagnostics business. The Director will be responsible for development and execution of comprehensive account management and project plans for pharma and biotech customers to utilize FMI's portfolio of pharma solutions, and specifically to advance the goals of the Companion Diagnostics business line. The role is both inward and outward facing as the individual will be the key point of contact for all matters relating to these CDx partnerships. The individual is expected to collaborate with internal stakeholders including BD peers, Strategic Alliances team, R&D, Regulatory and Finance to forecast and manage timelines, resource plans, critical path activities, and risks. As a member of the Business Development team, the Director will also have opportunities to contribute to other activities and projects across the team.

    • Deliver on quarterly/annual strategic objectives and revenue goals for CDx business line, and contribute to the overall Pharma team goals and success;
    • Interact closely with Strategic Alliances team to manage day-to-day operational and tactical aspects of pharma/biotech relationships. Key point of contact for all customer interactions post contract signing;
    • Builds relationships with senior-level R&D executives at partner organizations that enable identification and execution of additional value-creating opportunities, both specific to CDx as well as to the broader pharma solutions portfolio;
    • Drives progress against defined partner strategies; proactively raises issues and proposes solutions.
    • Contribute to the overall development of the pharma solutions portfolio and support, as appropriate, strategic transactions outside the direct Pharma business.



    • Advanced degree in a scientific discipline required, with an MBA or comparable experience.
    • 6-8+ years of experience in the oncology biopharmaceutical or diagnostic industry or a comparable position in clinical operations, or regulatory affairs in an academic cancer center.
    • Experience in Companion Diagnostics (CDx) preferred. Strong understanding of the regulatory and operational considerations in executing biomarker and companion diagnostic strategies in clinical development is preferred.
    • Experience leading multi-disciplinary development teams in the execution of operational plans; ideally across multiple functional areas and various development phases.
    • Demonstrated success in building and maintaining senior-level relationships at customer organizations.
    • Confident, ambitious, proactive individual capable of taking the initiative and driving to results.



    Apply Here

    PI92573450


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    Nominated by Fierce Biotech in 2014 as a “Fierce 15” company and recognized for its “proprietary approach to microbiomics that could change how physicians approach infectious disease,” Seres Therapeutics is well-positioned to become the first company to bring drugs to patients comprised of carefully selected bacteria (commensal organisms) derived from the microbiome of healthy humans. Seres is a dynamic biotechnology company in Cambridge, MA (Kendall Square) with a passion for developing new drugs in areas of high unmet need including inflammation and metabolic diseases. Seres is well-financed and has an advanced program for treatment of recurrent Clostridium difficile infection. As part of its efforts to grow its pipeline and expand the therapeutic impact of this novel treatment, Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas in 2015 and 2016.

     

    What's in it for you?

    In this role, you will have an opportunity lead the process in identifying and selecting suppliers while also rolling up your sleeves to perform the daily tactical tasks of PO issuance and tracking shipments. You will form close partnerships with Seres Technical experts (Bioprocess, Manufacturing and Quality) to understand the form, fit and function specifications and identify suppliers that can meet these requirements. This role will have a great impact to Seres in achieving its growth and launch objectives in a new and novel therapy where you will have the opportunity to drive supplier selection for materials, CMOs and equipment early on. This role reports to the Sr. Director, Supply Chain.

    How do you know if you're the right fit?

    If you are interested in being part of developing Seres' Strategic Sourcing function from the ground up; and if you enjoy leading the RFP process, working closely with stakeholders to select and qualify suppliers/CMO's to meet project timelines, negotiating contracts and developing short and long-term strategies that align with development and launch timelines, you're in luck. You will be capable of implementing a Supplier Scorecard system that drives performance and balances quality, service and cost as well have participate in the design and implementation of an ERP procurement module. While it would be great if you've done this before at a small biotech or contract manufacturer (CMO), what is most important is a strong drive to create something new.

     

     

     

    The other stuff

    This is typically a role best suited for a 5-8 year Bachelor level candidates (Chemistry or Biology), however an advanced degree (eg MBA) and/or CPM is desirable. You'll be a self starter with experience in technical purchasing for the biotech/pharmaceutical industry, and you'll possess demonstrated creative negotiating skills and possess the ability to comprehend details of supplier's technology/specifications. Also key are your ability to work simultaneously on multiple projects, be flexible enough to reprioritize work to ensure timely completion, and be a self-starter who can research, communicate and analyze best potential suppliers, and manage suppliers with results that are sustainable over time. Experience with ERP procurement (eg Oracle, SAP) and strong MS Office (Excel, PowerPoint, etc.) is a must.



    Apply Here

    PI92580862


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  • 12/22/15--00:56: Commercial Program Manager
  • Our client, a small and innovative biotech company in the Greater Boston area is seeking a talented and experienced Commercial Program Manager to drive all pre-launch activities for a critical late-stage program. If you are a detail oriented and driven individual with previous commercial program management experience, this is an amazing leadership opportunity for you! 

    The right individual for this role will possess excellent communication and organizational skills, problem solving abilities and business acumen.  The ideal candidate will have previous experience in launching, or being part of the launch, of a commercial product.  This individual will structure timelines, identify milestones and collaborate with senior leadership to assess, project and handle risks. 

    Requirements:

    • BS degree in biological sciences
    • 5-12 years relevant project/program management experience within the life science field, including prevous experience in the commercialization and launch of a product
    • Outstanding communication skills
    • Working knowledge of all aspects of the drug development process from preclinical through late stage clinical trials

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™

     

     


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  • 12/22/15--01:20: QC Associate (15-130)
  • The Position:

    This position supports Quality Control and stability data oversight of Sarepta in-house and outsourced Contract Test Laboratories (CTLs) in support of GMP compliance.  The individual will assist in monitoring, compiling and reviewing data with other members of a team.  The individual will also assist in managing quality events, review of quality documents such as protocols, reports and other quality documents.  The individual will ensure that all data and procedures are in concordance with the Sarepta Quality System and are error free.

    Primary Responsibilities Include:

    • Review of release and stability data and certificates of analysis received from CTLs
    • Assist in managing projects at the CTL sites and managing the work flow and priorities
    • As needed perform laboratory duties related to testing ologinucleotide synthesis intermediates and 20-30 mer oligonucleotides.
    • Conduct on-site method development and oligonucleotide analytical method validation.
    • Assist in writing and reviewing protocols, reports and other regulatory documents such as SOP, OOS/OOT and CAPA at vendor sites.
    • Assist in transferring assays to vendor sites and managing life cycle of those documents
    • Experience in managing aspects of a stability program is an added qualification
    • Deep understanding and work experience in a cGMP environment is added qualification.

    Education and Skills Requirement:

    • MS with 2 years or BS with 5 years in Chemistry or related science field.
    • 3-5 years in a QC/Stability laboratory environment, cGMP preferred
    • Experience with laboratory equipment operation namely HPLC, GC, LC-MS, GC-MS, ICP-OES/MS, KF, pH and an understanding of CCIT, Microbiological testing.
    • Attention to details is a must.
    • Strong organizational skills
    • Effective written and verbal communication skills
    • Operate independently or as a part of a team, experience training individuals in a laboratory environment. 
    • Experience in working in a CTL is highly desired.
    • Position may require some travel.

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    Job Title: Contract (6 months) - Manager, Clinical Operations 
    Department: Development Operations
    Reports to: Associate Director, Clinical Operations
    Location: Cambridge, MA 
    Requisition: RD-DO102

    Job Summary:

    Retrophin, Inc. is a biopharmaceutical company focused on discovering, developing, and marketing innovative therapies for debilitating and often life-threatening diseases. We have ongoing development programs for Focal Segmental Glomerular Sclerosis (FSGS), Pantothenate Kinase-Associated Neurodegeneration (PKAN), and others. The clinical trials associated with these development programs will be performed on a global scale in coordination with Contract Research Organizations (CROs). These trials will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We are seeking a Manager of Clinical Operations for a 6 month contract with a keen attention to detail who will be responsible for overseeing clinical operations/clinical trial management for several Phase I/early development trials. Under the guidance of Clinical Operations management, the individual will coordinate, track, and manage daily activities for multiple clinical trials to support both the internal project team and the CROs.

    Responsibilities:

    • Manage and provide daily oversight of full service CROs and third party vendors to ensure successful clinical trial implementation and execution. 
    • Collaborates with consultants and contractors to R&D.
    • Manages and communicates to senior management overall clinical operations plan for clinical early phase trials including timelines, internal and external resources/costs, and critical deliverables. 
    • In conjunction with the CRO, tracks study status, timelines, enrollment, regulatory documentation, and site start‐up status for assigned clinical trials. 
    • Forecast trial resource needs (external costs); accountable for the trial level clinical operations budget, management and tracking of trial budget in conjunction with CRO and contract manager. Review and approve site budgets, manage clinical trial budgets, collaborate with finance to provide input into financial reporting and projections.
    • Collaborate with other functional groups including Data Management, Pharmacovigilance and others to ensure precise review of the clinical trial data. Communicate key issues and mitigations to relevant cross-functional stakeholders.
    • Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.

    Requirements:

    • Bachelor’s degree, or equivalent, in a biomedical, life science, or related field of study, preferred.
    • 4-6 years of clinical operations experience in a pharmaceutical or CRO setting. 
    • Phase I trial management, or closely relevant experience is preferred. Preference for early development and healthy volunteer trial experience.
    • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. 
    • Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
    • Must possess a professional, "customer-service" demeanor and demonstrate effective communication capabilities for collaboration with others in a multi-disciplinary group.
    • Good problem solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.

    Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

     


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  • 12/22/15--04:03: Sr. Medical Science Liaison
  • Job Title: Sr. Medical Science Liaison - Mid-Atlantic 
    Reports to: MSL Director
    Department: Medical Affairs 
    Location: Philadelphia, PA (Maryland, Ohio, Pennsylvania, North Carolina, South Carolina) 
    Job Requisition #: RD-MA106

    Responsibilities:

    • Cultivating, maintaining and leveraging relationships with national, regional and local KOLs.
    • Fostering mutually productive partnerships with KOLs in the areas of medical education and clinical/scientific research.
    • Contributing to the development and implementation of medical education strategies and initiatives.
    • Supporting and moderating advisory board meetings and speaker training initiatives.
    • Maintaining cross-functional collaboration with internal teams: Clinical Research, Medical Information, Medical Communications, etc.
    • Contributing to publication planning, development of medical education material, internal training, etc.
    • Assist with both sponsored research (site identification, recruitment, etc.) and investigator initiated research (conduit, protocol champion, status updates, etc.)
    • Delivering medical presentations to diverse audiences effectively, including physicians, pharmacists, nurses, etc.
    • Adhere to corporate compliance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information
    • Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings

    Qualifications

    Education: PharmD, MD, PhD preferred

    Experience: 3+ years in the pharmaceutical industry, with experience as Medical Science Liaison

    Specific skills:

    • Rare disease experience and established KOL contacts in metabolic experts, geneticists and pediatric hepatologists/GI is a plus.
    • Excellent written and oral communication skills, along with highly effective presentation skills
    • Strong leadership and interpersonal skills and ability to work independently or in a team environment
    • Demonstrated ability to address educational and research needs through delivery of cutting edge scientific/evidenced based data 
    • Ability to establish strong relationships and discuss complex scientific topics in a peer to peer manner
    • Ability to think strategically and creatively
    • Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
    • Knowledge of FDA guidelines and regulations. 
    • Independent, self-starting individual with a demonstrated ability to thrive in smaller, biotech environments is required. 
    • Must be able to prioritize and work effectively in a constantly changing environment. Office is field based and preference is that candidate live in a state within the geography. Ability to travel up to 60-80%
    • In the field 3-4 days a week and travel to regional/national meetings as assigned. Some weekends will be required

    Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

     


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