Market Director – Orthopedics, Southern California
Tanner and Associates is recruiting for a Market Director – Orthopedics located in Southern California. The company specializes in medical devices that provide solutions for musculoskeletal health, vascular health, rehabilitation and pain management.
Job Description
Experienced marketing position with full P&L, strategic and tactical responsibilities for one or more product lines. Drives current and future strategy, authorizes go-to-market plans, executes product launch strategies, and owns revenue target for their applicable products. This is a customer facing position with a heavy emphasis on market execution and strategic vision.
Essential Duties and Responsibilities: (Other duties may be assigned)
- Responsible for Business Unit P&L
- Participates in training of healthcare professionals and sales personnel on the technical use of the product.
- Understands market trends, healthcare professional preferences, competitive strategies, etc. and uses this knowledge to guide development of plans.
- Authorizes business plans and marketing plans for products.
- Assembles and leads product launch teams to execute go-to-market strategies.
- Plans and executes market research activities to drive product development strategies.
- Establishes capital requirements and forecasting models.
- Establishes list pricing and discounting strategies keeping in line with the company’s margin objectives.
- Creates KPIs (key performance indicators) for products following launch.
- Establishes relationships with healthcare professionals and manages those relationships during product development process.
- Develops the proper messaging for applicable products and incorporates into tools to be use by the sales organization.
- Creates and updates sales and training materials (i.e. technical training materials).
- Attends industry meetings and trade shows and generates and follows up on sales leads.
- Provides technical data for inclusion in healthcare professional techniques and product brochures.
- Works cross functionally with product development, sales operations, regulatory, sales and finance to accomplish objectives.
Qualifications:
- Bachelor’s degree, preferably in Business/Marketing.
- 7-8+ years related experience and/or training; or equivalent combination of education and experience, preferably in the medical device arena.
- Must have the ability to think strategically.
- Must be effective at driving brand strategy, strategy comprehension, and strategy consensus within a diverse group of stakeholders.
- Excellent project management skills including planning, organization, implementation, achievement of deadlines, and ability to multi-task in a fast paced environment.
- Demonstrated competence with general computer skills: Word, PowerPoint, Excel, and Internet.
- Must have excellent verbal and written communication skills.
For more information, please contact Tanner and Associates at 760-598-3363 or email CVs to careers@biotechsearch.com . Upload CVs and check additional postings at www.biotechsearch.com .
MEDICAL SCIENCE LIAISON (MSL), ONCOLOGY (FIELD BASED – NE, MIDWEST, SOUTHERN CALIFORNIA)
Tanner and Associates is recruiting for a MSL, Oncology on behalf of a worldwide healthcare company with core strengths in specialty pharmaceuticals, women’s healthcare, cardiology, hematology and oncology.
POSITION DESCRIPTION:
The field based (NE, Midwest, Southern California) Medical Science Liaison (MSL) will support the company’s Oncology franchise for both marketed and development products. The company’s marketed product is for the treatment of renal cell carcinoma. The company also has several developmental pipeline products being evaluated for the treatment of other forms of cancer. Openings are for New England, Midwest (based in Chicago or Minneapolis) and Southern California.
RESPONSIBILITIES:
- The MSL will act as a scientific expert and will be responsible for the dissemination, clarification and education of scientific data and material.
- Candidate will establish long-term scientific/strategic relationships with key physicians/scientists, related major medical associations, and academic centers.
- MSL will use experience with key external medical and pharmacy professionals through the process of one-on-one interaction, small group discussions, and symposia lecture presentations including exchanges associated with sponsored medical education programs and protocols.
- Facilitate opinion leader involvement in national, regional and local educational forums including advisory boards and continuous medical education (CME) venues.
- Enable principal investigators to develop their research interests by serving as facilitator for investigator-initiated studies, and managing submissions of letters of intent to the internal review committee.
- Serve as the company liaison with oncology cooperative groups, assisting strategic development of the group’s strategy.
- Serve as an expert consultant to internal cross-functional partners within the company by providing product related scientific information and technical support for training.
- Responsible for communicating relevant information from KOLs to key cross-functional partners.
- Provide opportunities for top leaders to participate in scientific forums and assist in gathering resources for projects.
- Leverage networks, CME contacts and current speaker development priorities to develop program opportunities that highlight portfolio relevant disease state information and management.
- Responsible to ensure that speakers are thoroughly knowledgeable and trained utilizing the most current information covering products.
- Serve as the expert resource on products and associated disease states to Field Sales and other internal cross-functional groups.
- Provide technical/scientific information as well as guidance in the development of educational programs needed to enhance corporate goals and initiatives.
QUALIFICATIONS:
- PharmD or PhD with 5 years experience with a biotechnology/ pharmaceutical company with experience with Phase II/III/IV trials as a medical science liaison or as a clinical research scientist.
- Related experience in a major academic/medical center will also be considered.
- Experience in Clinical Oncology with a basic knowledge of Oncology products and disease states. Experience with investigator-sponsored trials is preferred. Must understand the FDA/GCP requirements regarding clinical research trials.
- Must be able to understand, interpret and communicate complex scientific information and data.
- Possess in-depth scientific and technical knowledge of company products versus competitor’s products plus the disease states that are used in treatment.
For more information, please contact Tanner and Associates at 760-598-3363 or email CVs to careers@biotechsearch.com . Upload CVs and check additional postings at www.biotechsearch.com .
DIRECTOR, DRUG SAFETY & PHARMACOVIGILANCE
DIRECTOR, DRUG SAFETY & PHARMACOVIGILANCE
Tanner and Associates is recruiting for a Director of Drug Safety and Pharmacovigilance for a leading company located in the NE. The company engaged in the discovery, development and commercialization of products for the treatment of various pulmonary diseases.
JOB DESCRIPTION
- Candidate will be responsible for planning, developing, and managing drug safety and pharmacovigilance processes for therapeutics involving investigational and post-marketing drug studies.
- Functions include the collection, evaluation and communication of safety information, pharmacovigliance and safety support for clinical trials.
- Candidate will work with vendors to ensure compliance with national and international regulations and requirements.
- Pharmacovigilance activities related to the company’s marketed product are primarily conducted by its marketing partner.
- Candidate will ensure that the company follows appropriate internal processes regarding communication of safety information to its partner.
- Candidate will serve as the primary point of contact with the company’s business partners and will provide internal safety support for the R&D and marketing teams.
RESPONSIBILITIES
- Responsible for ensuring that worldwide Adverse Drug Reporting System adequately captures safety data.
- Ensures the clinical safety of clinical trial studies meet required company and regulatory requirements.
- Evaluates adverse event safety reports and provides ongoing communication between Clinical and Global Safety.
- Maintains the Safety Management Plan/Operating Agreement between the company and the external Safety Vendors.
- Oversees the Drug Safety processes performed by vendors to ensure accuracy, medical appropriateness, and timely delivery of safety data.
- Evaluates vendor SOPs and determine vendor compliance with SOPs, ICH/GCP and applicable regulations.
- Assists in developing audit plans of company vendors, internal safety and pharmacovigilance operations, and ensuring that any findings from audits are properly addressed.
- Accountable for budgeting, headcount, outsourcing strategy and management of a quality pharmacovigliance system to ensure proper risk management of company products are in compliance with all international regulations and guidelines.
QUALIFICATIONS
- Requires M.D. with advanced training in Internal Medicine. Additional training in Pulmonary/Critical Care medicine or Cardiology is a strong plus.
- Board certification/eligibility in a medical discipline.
- 5 years industry experience in biopharmaceutical research and development or with a CRO.
- At least 3 years experience in Drug Safety and Pharmacovigilance.
- Strong knowledge of applicable laws, regulations, guidelines and best practices.
- Working knowledge of case processing, signal detection, regulatory reporting process and workflow.
- Working knowledge of Medora coding and terminology.
- Experience managing CROs and other contractors.
- Experience should include investigational and postmarketing studies with proficiency in Drug Safety processes, Adverse Event Reporting, Risk Management, and Signal Detection.
- Experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans.
For more information, please contact Tanner and Associates at 760-598-3363 or email CVs to careers@biotechsearch.com . Upload CVs and check additional postings at www.biotechsearch.com .
Tanner and Associates is recruiting for a Director of Drug Safety and Pharmacovigilance for a leading company located in the NE. The company engaged in the discovery, development and commercialization of products for the treatment of various pulmonary diseases.
JOB DESCRIPTION
· Candidate will be responsible for planning, developing, and managing drug safety and pharmacovigilance processes for therapeutics involving investigational and post-marketing drug studies.
· Functions include the collection, evaluation and communication of safety information, pharmacovigliance and safety support for clinical trials.
· Candidate will work with vendors to ensure compliance with national and international regulations and requirements.
· Pharmacovigilance activities related to the company’s marketed product are primarily conducted by its marketing partner.
· Candidate will ensure that the company follows appropriate internal processes regarding communication of safety information to its partner.
· Candidate will serve as the primary point of contact with the company’s business partners and will provide internal safety support for the R&D and marketing teams.
RESPONSIBILITIES
- Responsible for ensuring that worldwide Adverse Drug Reporting System adequately captures safety data.
- Ensures the clinical safety of clinical trial studies meet required company and regulatory requirements.
- Evaluates adverse event safety reports and provides ongoing communication between Clinical and Global Safety.
- Maintains the Safety Management Plan/Operating Agreement between the company and the external Safety Vendors.
- Oversees the Drug Safety processes performed by vendors to ensure accuracy, medical appropriateness, and timely delivery of safety data.
- Evaluates vendor SOPs and determine vendor compliance with SOPs, ICH/GCP and applicable regulations.
· Assists in developing audit plans of company vendors, internal safety and pharmacovigilance operations, and ensuring that any findings from audits are properly addressed.
· Accountable for budgeting, headcount, outsourcing strategy and management of a quality pharmacovigliance system to ensure proper risk management of company products are in compliance with all international regulations and guidelines.
Qualifications
· Requires M.D. with advanced training in Internal Medicine. Additional training in Pulmonary/Critical Care medicine or Cardiology is a strong plus.
· Board certification/eligibility in a medical discipline.
· 5 years industry experience in biopharmaceutical research and development or with a CRO.
· At least 3 years experience in Drug Safety and Pharmacovigilance.
· Strong knowledge of applicable laws, regulations, guidelines and best practices.
· Working knowledge of case processing, signal detection, regulatory reporting process and workflow.
· Working knowledge of Medora coding and terminology.
· Experience managing CROs and other contractors.
· Experience should include investigational and postmarketing studies with proficiency in Drug Safety processes, Adverse Event Reporting, Risk Management, and Signal Detection.
· Experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans.
For more information, please contact Tanner and Associates at 760-598-3363 or email CVs to careers@biotechsearch.com . Upload CVs and check additional postings at www.biotechsearch.com .
Medical Director Drug Safety
Tanner and Associates is currently recruiting for a Medical Director to serve as a Global Safety Officer focusing on Bone Therapeutics.
Job Description:
The Global Safety Medical Director is responsible for dictating the direction and priorities of the Global Safety Team and is accountable for all product safety related decisions for assigned products and is the key company interface for this department. The Global Safety Medical Director is supported by the Global Safety Project Manager and is responsible for the timely communication of safety recommendations and/or actions from the Safety Team to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head.
Key Activities:
• Accountable for identification, assessment, and communication of potential safety signals as Team Leader for pharmacovigilance activities
• Lead response to regulatory safety queries
• Lead development of strategy and creation of product risk management plans including maintenance and updates
• Accountable for Global Safety Strategic Plan
• Safety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boards
• Participate in planning, review and sign off of clinical trial safety documents for content including:
o Clinical Summary of Safety (CSS)
o 120 Day safety update
o Protocol safety sections
o CSRs
o ICFs
o Study safety monitoring plans
o Investigator Brochures
Preferred Qualifications:
• Drug safety, biotech/pharmaceutical or regulatory agency experience
• Board Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS
• Accredited subspecialty fellowship, e.g. oncology, endocrinology, epidemiology, clinical immunology, nephrology or clinical experience in clinical pharmacology
• Previous safety experience in oncology or bone disorders
• Previous clinical development experience in oncology or bone disorders
Basic Qualifications:
• MD or DO degree from an accredited medical school
• 2+ years of safety experience
• Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
For more information, please contact Tanner and Associates at 760-598-3363 or email a CV at careers@biotechsearch.com
Sincerely,
Tanner and Associates
760-598-3363
careers@biotechsearch.com
Principal Clinical System Programmer in Southern California
Tanner and Associates is recruiting a Principal Clinical System Programmer to be based in Southern California. Please contact me for more information.
Job Description
Leads the design, development, validation, implementation, and provides ongoing support of electronic systems e.g., Electronic Data Capture (EDC), reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., PL/SQL) used in Clinical Research and Development studies. The responsibilities include:
- Analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies.
- Assist in the validation of electronic systems and programs.
- Works with Clinical Data Management, Clinical Programming, Statistical Programming, Biostatistics, and the Clinical Research functions to analyze and implement clinical information technology solutions.
- Responsible for peer review and maintenance of database systems and tools to support Global Development activities.
- Provide leadership and content expertise for programming activities in support of Global Development to effectively manage data capture, review and database lock activities
- Assist with the role which includes Definition, Capture and Delivery of Clinical Study Data. Peer review of deliverables.
- Responsible for maintenance of Global Libraries and ensuring their synchronization with department standards
- Responsible for participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities .
- Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines .
Qualifications
- Degree or equivalent experience in Computer Science, Life Science or related field
- Previous experience of leading eCRF builds within a clinical programming organization, preferably within a medium-large Pharma or CRO.
- Previous experience of working with EDC systems (e.g. Phase Forward InForm Architect or Central Designer)
- Previous experience of working with Reporting/Business Intelligence Tools (e.g. Business Objects, Spotfire)
- Ability to effectively interact with and influence others without direct reporting relationships
- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
- Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
- Working knowledge of global standards related to clinical study data management activities (eCRF/CRF design, data standards, database design, coding and coding dictionaries, etc.)
- Ability to travel 5%
For more information, contact:
Tanner and Associates
760-598-3363
careers@biotechsearch.com
Manager, Clinical Programming in Southern California
Tanner and Associates is recruiting a Manager, Clinical Programming to be based in Southern California. Please contact me for more information.
Job Description
Manage internal and outsourced Clinical Programming personnel and activities in support of Clinical Research and Development studies. Manage the design, development, validation, implementation, and provide ongoing support for electronic systems (e.g., Clinical Data Repositories/Warehouses, Oracle Clinical, etc), reporting/business intelligence tools (e.g., Business Objects, Spotfire), and industry standard compliant datasets (e.g., CDISC SDTM) using ETL technologies (e.g., Informatica Powercenter) and programs (e.g., SAS, PL/SQL). Analyze Clinical Study design requirements against third party system specifications to support the implementation of clinical systems. Support the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements. Manage the implementation of programming standards and conventions.
Clinical Programmer
Responsible for document creation, development, peer review, validation, and maintenance of database systems and tools to support clinical research activities. Provide leadership and content expertise for programming activities from startup through the statistical analysis stage of clinical studies.
Data Integration Programmer
Responsible for integration, aggregation, delivery, and creation of technical documentation. Peer review of deliverables. Main technical interface with the External Data Providers. Creation of industry standard compliant Data Tabulation Datasets (e.g., CDISC SDTM).
Global Librarian
Responsible for maintenance of Global Libraries and ensuring their synchronization with department standards (e.g. Standard Data Elements). Review and approval of new programming objects prior to their use for study database set-up.
Line Function Manager
Responsible for planning, organization, and management of all internal and external programming activities supporting clinical trials. Hire, train and manage performance of staff inclusive of orientation, training, personal development, completing and administering performance evaluations). Works closely with human resources to ensure timely hiring of qualified resources.
Line Function Lead
Responsible for developing procedures and documentation in support of the definition of, and project planning and requirements for study-specific program and software development.
Vendor Selection and Management Team Member
Responsible for participating in the vendor selection process and managing the vendor as necessary.
AGN Personnel / Subject Matter Expert
Responsible for participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities including all forms of electronic data capture through in-house or third party vendors. Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions. Report process gaps and potential misconduct during clinical studies to management.
Qualifications
- Degree or equivalent experience in Computer Science, Life Science or related field: BS/BA degree with 9 years experience, or MS degree with 7 years experience, or PhD degree with 4 years experience.
- Minimum 4 years experience in a leadership role within a clinical programming organization, preferably within medium-large pharma or CRO.
- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
- Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards.
- Working knowledge of global standards related to clinical study data management activities (CRF design, data standards (CDISC; SDTM), database design, coding and coding dictionaries, etc.).
- Ability to effectively interact with and influence others without direct reporting relationships
- Technical abilities and skills in the analysis, design, specification and programming of computer systems using tools such as Powercenter, SAS. Knowledge of UNIX, Oracle a plus.
- Technical writing skills and experience
- Planning, organizational, and project management skills
- Ability to travel 15%
For more information, please send a CV to Tanner and Associates at careers@biotechsearch.com.
Tanner and Associates
760-598-3363
careers@biotechsearch.com
2 Medical Affairs Managers – Georgia and Carolinas
Tanner & Associates is recruiting TWO Medical Affairs Managers for a large pharmaceutical company based in Georgia and the Carolinas. Please send CV to careers@biotechserach.com
Responsibilities:
- Medical affairs and customer relation’s management with key national and regional opinion leaders and centers of influence.
- Support, development, and delivery of regional medical education programs
- Speaker development and maintenance
- Phase 3b / 4 research trial site support and investigator initiated research proposal cultivation and facilitation.
- Scientific support at key regional and national congresses
- Competitive intelligence gathering and assimilation
- Responding to unsolicited off-label requests that require personal communications
- Hospital formulary, regional managed care, and government account support and presentations.
- Sales force support dictated by the magnitude medical and scientific rigor required
- Regional sales force medical and scientific product related training
- Territory management
Qualifications:
- Terminal Doctorate Degree (Pharm.D., M.D., Ph.D)
- Experience as liaison in pharmaceutical industry preferred.
- Post-graduate teaching and training preferred
- Firm background in scientific methodology, general pharmacology and therapeutics
- Understanding of basic clinical research and statistics
- Ability to travel overnight
- Ability to drive up to 3 hours
- Ability to organize and work within a home office environment
Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com. US candidates only please.
Thanks,
Craig Tanner
Tanner & Associates
760.598.3363
Clinical Research Medical Director, Nephrology – California
Tanner & Associates is recruiting a Clinical Research Medical Director in Nephrology for a large biotech company based in California. Please send CV to careers@biotechserach.com
Summary: The Company is strengthening its focus on Nephrology and is seeking to fill several key positions to work on various programs in early and late stage clinical development.
Key Responsibilities:
- Supporting the development, execution and communication of the global scientific/medical evidence plan
- Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
- Supporting the development of key scientific external relationships with opinion leaders
- Participating and providing clinical input into safety and regulatory interactions
- Based on the needs of the Therapeutic Area, this role may be required to provide clinical and medical support for filing and approvals of molecules in expansion countries.
- Provide clinical/scientific input during the development and execution of clinical trials
- Interpret clinical trial data
- Participates in conducting safety assessments.
- Participates in interactions with regulatory agencies.
- Authors clinical study reports, publications and regulatory submissions
- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings
- Identify new clinical research opportunities
- Support in-licensing and out-licensing activities and partner relationships
- Support product lifecycle management for new indications
Qualifications:
- MD with 2 or more years of clinical research and/or basic science experience combined with clinical teaching and patient care activities, 5 or more years is preferred.
- MD plus accredited residency in Nephrology, board certified or equivalent.
- Clinical research experience in the biopharmaceutical industry, biotechnology, and pharmaceutical
- Demonstrated ability to serve as a medical expert in a complex matrix environment.
Medical/Scientific Knowledge:
- In depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
- Familiar with basic concepts of clinical research and clinical trial design, including biostatistics.
- Knowledge of GCP, FDA and EMEA/CHP regulations and guidelines and applicable international regulatory requirements.
Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com . US candidates only please.
Thanks,
Jake Tanner
Tanner & Associates
760.598.3363
Clinical Research Medical Director, Oncology – California
Tanner & Associates is recruiting a Clinical Research Medical Director in Oncology for a large biotech company based in California. Please send CV to careers@biotechserach.com
Summary: The Company is strengthening its focus on Oncology drug development and is seeking to fill several key positions to work on various programs in early and late stage clinical development.
Key Responsibilities:
- Develops and executes medical strategies and provides scientific and medical input into the development of clinical programs.
- Leads the planning and execution of scientific deliverables outlined in the company’s Regional North American Medical Plan.
- Supports cross-functional and global collaborations to integrate broad medical, scientific and commercial input into the development program.
- Provides medical/scientific support for regional brand strategic objectives.
- Develops and manages key external and regional relationships according to the Key Opinion Leader Plan.
- Makes scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated.
- Participates in conducting safety assessments.
- Participates in interactions with regulatory agencies.
- Authors clinical study reports, publications and regulatory submissions
- Designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practices.
- Analyzes and interprets clinical study data and prepare reports for FDA and publications.
- Serves as the primary medical monitor on assigned projects.
Qualifications:
- MD with 5 or more years of clinical research and/or basic science experience combined with clinical teaching and patient care activities involving Oncology therapeutics.
- Board certified or eligible in an appropriate medical discipline is preferred especially in Oncology.
- Familiar with investigators or institutions in Oncology.
- Clinical research experience in the biopharmaceutical industry.
- Demonstrated ability to serve as a medical expert in a complex matrix environment.
Medical/Scientific Knowledge:
- In depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
- Familiar with basic concepts of clinical research and clinical trial design, including biostatistics.
- Knowledge of GCP, FDA and EMEA/CHP regulations and guidelines and applicable international regulatory requirements.
Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com . US candidates only please.
Thanks,
Jake Tanner
Tanner & Associates
760.598.3363
Clinical Research Medical Director, Pulmonology – California
Tanner & Associates is recruiting a Clinical Research Medical Director in Pulmonology for a large biotech company based in California. Please send CV to careers@biotechserach.com
Key Responsibilities:
- Develops and executes medical strategies and provides scientific and medical input into the development, execution and communication of global scientific/medical evidence plan for Asthma molecules in Development.
- Provides medical support in the development of a leading asthma molecule in phase II.
- Leads the planning and execution of scientific deliverables outlined in the company’s Regional North American Medical Plan.
- Supports cross-functional and global collaborations to integrate broad medical, scientific and commercial input into the development program.
- Provides medical/scientific support for regional brand strategic objectives.
- Develops and manages key external and regional relationships according to the Key Opinion Leader Plan.
- Makes scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated.
- Participates in conducting safety assessments.
- Participates in interactions with regulatory agencies.
- Authors clinical study reports, publications and regulatory submissions
- Designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practices.
- Analyze and interpret clinical study data and prepare reports for FDA and publications.
- Serves as the primary medical monitor on assigned projects.
Qualifications:
- MD with 5 or more years of clinical research and/or basic science experience research, required.
- MD, Board Certified or Board Eligible in Pulmonology or Allergy/Immunology.
- Five or more years of clinical research experience combined with clinical teaching and patient care.
- Familiar with investigators or institutions in Pulmonology.
- Clinical research experience in the biopharmaceutical industry (Biotech, Pharmaceutical or CRO).
- Demonstrated ability to serve as a medical expert in a complex matrix environment.
Medical/Scientific Knowledge:
- In depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
- Familiar with basic concepts of clinical research and clinical trial design, including biostatistics.
- Knowledge of GCP, FDA and EMEA/CHMP regulations and guidelines and applicable international regulatory requirements.
Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com . US candidates only please.
Thanks,
Jake Tanner
Tanner & Associates
760.598.3363
