(US) Client is a Midwest biopharmaceutical company dedicated to the discovery, development and commercialization of therapies to treat cardiovascular and metabolic diseases. Our client has an opening for a Senior Clinical Scientist. This full-time position is for a dedicated person to be responsible for the implementation and execution of clinical trials under the supervision of the Director of Clinical. Responsibilities include: Working with the Director and Senior Director to design, prepare and implement clinical protocols and amendments; direct the protocol specific activities of outside contractors, and report protocol results. Candidates will participate on development teams and will interact with internal and external experts during individual, investigator and expert meetings. The candidate will also plan investigator meetings, identify, evaluate, and recruit clinical investigators, and supervise ongoing CRO relationships and performance. Candidate will resolve patient/subject eligibility and protocol deviation issues, monitor subject safety and participate in addressing issues from regulatory agencies. Candidate will prepare clinical outsourcing specifications for RFPs and will develop, negotiate and manage study budgets. Additional responsibilities include participating in interim and final report preparation for regulatory submission, contributing to the preparation of the clinical elements of a BLA/NDA, and participation in major scientific meetings. Requirements: The position requires proven scientific and clinical expertise relevant to pharmaceutical clinical trial programs. Candidate must have depth of knowledge to represent department on development teams and to critically evaluate strategies for clinical trials and outside expert advice. Proficiency in clinical studies involving complex design issues and experience in preparation of clinical sections of IND, BLA, or NDA is desired. The ideal candidate will have a RN, MS, or MPH degree, 6+ years of experience & expertise in pharmaceutical clinical trial programs. Experience or education relevant to the development of therapeutic agents for cardiovascular or lipid modulating indications is preferred.
(US) Client is a Midwest biopharmaceutical company. Position: Director of Product & Process Development This Director will lead the Product Process Development group and drive the implementation of world class processes for the development and production of the company’s biopharmaceutical large and small molecule product candidates. Responsibilities include working with the management team to develop strategies for prioritizing and implementing best product process development plans and practices for the various product areas. The Director will also be responsible for developing a strategic plan and tactical methodology for scaling up production of product candidates to support clinical trials, and eventual commercialization and distribution to market. This person will be expected to help lead the negotiations with potential partners, suppliers, and technology vendors as necessary to scale up production. Requirements: The ideal candidate will have a post-graduate degree in engineering, science, or a related field and a minimum of 10 years experience in working with external CMO’s for product process development. Candidate will also have demonstrated expertise in developing processes to support complex production methods and proficiency working with both large and small molecule production. The successful candidate will be hands-on, dynamic, self-motivated, and have an engineering mindset with a focus on product process development and implementing processes. The ability to work within critical timelines is essential, as are planning, communication, and leadership skills.
(Singapore) Qualifications & Experience: - Post-graduate Pathologist with qualifications recognized by the Singapore Medical Council - Minimum 5 years working experience as a Consultant pathologist - Posses working knowledge of all phases of Histopathology and Cytology - Experienced in the overall operations of all clinical laboratory sections. Duties & Responsibilities as Medical Director: - Overseas the professional and technical aspect of all lab testing - Provides oversight of the company/laboratory’s ongoing quality assurance programs - Represent the company/laboratory in all Medical Professional forums as well as with licensing and regulatory organizations - Interact with the company/laboratory’s clients eg. hospitals and doctors on an ongoing basis - Work closely with the General Manager to ensure the laboratory maintains the highest achievable clinical standards and client service levels - Participate in staff training programs for all sections of the laboratory on request of the GM responsibilities for primary training of staff in all phases of Histopathology and Cytology as Chief Consultant Pathologist: - Responsible for ensuring both the accuracy and timeliness of frozen sections, cytology examinations, and all other pathology tests, procedures, and consultants - Actively interacts with client doctors and hospitals on matters involving laboratory results and findings as well as, when requested, other aspects of the laboratory’s operations - Responsible for the establishment, maintenance and periodic review of pathology records - Responsible for the performance of all employed (and invited consultant) pathologists. - Ensures the proper performance of all duly authorized autopsies - Work with the General Manager and Technical Manager to establish and maintain all clinical protocols and laboratory policies and procedures.
