Clinical Research Medical Director, Bone Health– California
Tanner & Associates is recruiting a Clinical Research Medical Director in Bone Health for a large biotech company based in California. Please send CV to careers@biotechserach.com
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
- 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
- Develops 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 Endocrinology, Rheumatology, Orthopedic Surgery, 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
Senior Manager, Statistical Programming/SAS Programming – San Francisco
Tanner and Associates is recruiting a Senior Manager, Statistical Programming/SAS Programming for a large biotech company based in San Francisco. Full Relocation services provided within the US. Send a CV to careers@biotechsearch.com .
Summary:
- The Senior Manager, Statistical Programming will be responsible for providing project management of statistical programming activities.
- They will deliver against the overall protocol timeline, cost, and quality goals through matrix communication with the study team and will be accountable for the provision of standard and non-standard datasets, tables, listings, and figures that are required for the study reports, submissions or publications.
- The Senior Manager, Statistical Programming will enforce standard of programming approaches and provide continuous improvement of processes and communicate effectively not only within the teams and functional lines but also with the external resources.
- In addition, they will lead the programming team to prepare for electronic submission activities including project plans, specifications, resource allocation, and deliverables in timely fashion.
- They will provide filing, approval and regulatory programming support for all aspects of a submission and contribute technical expertise to team deliverables and coach/train new programmer or processes related to team deliverables.
- They will also assess the impact of procedural or system changes, and develop/implement strategies to maintain consistency of programming.
Qualifications:
- MS degree and a minimum of 8 or more years experience in Statistics, Computer Science, or related field within a clinical programming organization, preferably within medium-large pharmaceuticals or CRO, 3 or more years experience in managing statistical programming aspects of clinical trials and direct reports, and NDA/BLA experiences a plus.
- Significant knowledge and experience with SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and applicable regulations as well as proven knowledge of regulatory document and reporting systems.
- Experience must include in-depth knowledge of CDISC in SDTM and ADaM, Metadata, and controlled terminologies.
- Proficiency in SAS and at least one programming environment such as VB Scripts and JAVA.
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
Manager Clinical Operations—Los Angeles relocation available
Tanner & Associates is recruiting a Manager in Clinical Operations for a large biotech company based in Los Angeles. Full relocation services provided within the US. Send a CV to careers@biotechsearch.com .
Summary:
- Manage clinical studies and represent clinical operations in an R&D core team environment
- Collaborate with key cross functional leaders
- Be responsible for: project quality, timeline and budget as well as protocol development, investigator selection, study initiation, monitoring, procedures, analysis, timely reports, monitoring guidelines, and site training
- Establish him/herself as a reliable, trusting resource of accurate, up-to-date project knowledge
- Insures adherence to FDA inspection and other regulatory authority standards
- Identify and communicate unexpected clinical events or tests results with corrective action and write clinical protocols and prepare data collection forms for clinical studies
- Review and make recommendations to FDA and EU submissions
Qualifications:
- BA in Life Sciences or related field
- Min of 7 years clinical research experience
- Min of 2 years successful managerial experience in a matrix environment
- Experience managing multicenter global clinical trials
- Solid working knowledge of Good Clinical Practices (GCP)
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
Medical directors of Oncology Clinical Research—Salt Lake City
Tanner and Associates is recruiting several Medical directors of Oncology Clinical Research for several large Biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey. Candidate can be based out of any of these locations.
Requirements:
Several Major Biotech companies are seeking Medical Director/Clinical Scientist with drug development experience to join the Oncology program. The candidate should have an M.D. with board certification/eligibility in hematology/oncology,or a Phd,PharmD with at least 5 years of drug development experience. Prior experience of clinical trials in an oncology related field is preferred. Candidates must be comfortable proactively solving issues and working independently.
Job Duties and Responsibilities are primarily focused, but not restricted to the design, implementation, analysis and interpretation of clinical trials from phase I-III. The candidate will be expected to make a significant contribution to the strategic direction of the Oncology programs, including clinical trial design, implementation, analysis, interpretation and dissemination of results as detailed below. In addition the candidate will be required to build and maintain excellent relationships with outside parties including clinical investigators and advisors, regulatory authorities and other Government institutions (eg NCI), and collaborating companies.
Responsibilities:
Design:
- Design of clinical experiments, including drafting of protocol summaries and providing clinical input to complete protocols
- Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings
- Serve as a key member on the Clinical SubTeam. Provide significant input into the clinical development/strategy
Implementation:
- As Medical Monitor, to be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines
- Partner with Data management for CRF and Tables, listings and figures design and data quality plan
- Medical monitoring of Phase I-III trials including serving as the primary Clinical Science contact on the Protocol Execution Teams(s) and the primary liaison for clinical operations and the primary point of contact for Medical Monitor inquiries from sites, monitors and CROs
- Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
Analysis and Interpretation:
- Analysis of interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the Company
Competencies:
- Excellent technical understanding of oncology
- Excellent technical understanding of the clinical trial process and in particular the role of the Medical Monitor, including compliance requirements, ICH, etc
- Excellent written and verbal communication skills
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
Medical directors of Oncology Clinical Research – San Francisco
Tanner and Associates is recruiting several Medical directors of Oncology Clinical Research for several large Biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey. Candidate can be based out of any of these locations.
Requirements:
Several Major Biotech companies are seeking Medical Director/Clinical Scientist with drug development experience to join the Oncology program. The candidate should have an M.D. with board certification/eligibility in hematology/oncology,or a Phd,PharmD with at least 5 years of drug development experience. Prior experience of clinical trials in an oncology related field is preferred. Candidates must be comfortable proactively solving issues and working independently.
Job Duties and Responsibilities are primarily focused, but not restricted to the design, implementation, analysis and interpretation of clinical trials from phase I-III. The candidate will be expected to make a significant contribution to the strategic direction of the Oncology programs, including clinical trial design, implementation, analysis, interpretation and dissemination of results as detailed below. In addition the candidate will be required to build and maintain excellent relationships with outside parties including clinical investigators and advisors, regulatory authorities and other Government institutions (eg NCI), and collaborating companies.
Responsibilities:
Design:
- Design of clinical experiments, including drafting of protocol summaries and providing clinical input to complete protocols
- Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings
- Serve as a key member on the Clinical SubTeam. Provide significant input into the clinical development/strategy
Implementation:
- As Medical Monitor, to be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines
- Partner with Data management for CRF and Tables, listings and figures design and data quality plan
- Medical monitoring of Phase I-III trials including serving as the primary Clinical Science contact on the Protocol Execution Teams(s) and the primary liaison for clinical operations and the primary point of contact for Medical Monitor inquiries from sites, monitors and CROs
- Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
Analysis and Interpretation:
- Analysis of interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the Company
Competencies:
- Excellent technical understanding of oncology
- Excellent technical understanding of the clinical trial process and in particular the role of the Medical Monitor, including compliance requirements, ICH, etc
- Excellent written and verbal communication skills
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
Director Oncology Medical Affairs, Western Region – Can Be Home Based
Tanner and Associates is recruiting a Director Oncology Medical Affairs located within the western part of the US. Candidate must be an MD with Oncology Experience. Position can be home based within the Western US.
Key Responsibilities:
• Interact with key opinion leaders regarding clinical claims for products and research opportunities
• Deliver lectures as required before health care providers concerning products and their use
• Provide medical and scientific expertise to diligence projects exploring licensing/acquisition opportunities
• Assist Medical and Marketing/Sales on setting up and supporting Ad Boards, Speaker Training and External Payor Reviews as needed
• Help in strategizing/problem-solving/prioritizing issues related to the medical marketplace and physician interaction
• Help manage the investigator-initiated study program
• Work with key departments (Medical, Sales, Marketing, Managed Care, etc.) in developing and implementing successful training programs as needed
Qualifications:
• MD degree required; medical oncology specialty training preferred
• Strong clinical/medical background (training and/or experience) with ability to successfully communicate and teach in a complex and competitive environment
• 1-3 years experience in a Medical Affairs organization preferred; will consider highly qualified candidates with less experience
• Strong interpersonal, organizational and communication skills both written and oral
• Ability to communicate (clearly) complex messages at all levels of the organization (organizational agility)
• Public speaking ability and facility required
Technical Fluency
Candidate must skillfully learn and adapt medically related product concepts and complexities to sales and marketing environment. Must train Sales Team to best utilize marketing materials in their efforts to educate and influence external customers.
Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com . US candidates only please.
Thanks,
Jake Tanner
Tanner & Associates
Careers@biotechsearch.com
760.598.3363
Senior Manager, Statistical Programming/SAS Programming – San Francisco
Tanner and Associates is recruiting a Senior Manager, Statistical Programming/SAS Programming for a large biotech company based in San Francisco. Full Relocation services provided within the US. Send a CV to careers@biotechsearch.com .
Summary:
- The Senior Manager, Statistical Programming will be responsible for providing project management of statistical programming activities.
- They will deliver against the overall protocol timeline, cost, and quality goals through matrix communication with the study team and will be accountable for the provision of standard and non-standard datasets, tables, listings, and figures that are required for the study reports, submissions or publications.
- The Senior Manager, Statistical Programming will enforce standard of programming approaches and provide continuous improvement of processes and communicate effectively not only within the teams and functional lines but also with the external resources.
- In addition, they will lead the programming team to prepare for electronic submission activities including project plans, specifications, resource allocation, and deliverables in timely fashion.
- They will provide filing, approval and regulatory programming support for all aspects of a submission and contribute technical expertise to team deliverables and coach/train new programmer or processes related to team deliverables.
- They will also assess the impact of procedural or system changes, and develop/implement strategies to maintain consistency of programming.
Qualifications:
- MS degree and a minimum of 8 or more years experience in Statistics, Computer Science, or related field within a clinical programming organization, preferably within medium-large pharmaceuticals or CRO, 3 or more years experience in managing statistical programming aspects of clinical trials and direct reports, and NDA/BLA experiences a plus.
- Significant knowledge and experience with SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and applicable regulations as well as proven knowledge of regulatory document and reporting systems.
- Experience must include in-depth knowledge of CDISC in SDTM and ADaM, Metadata, and controlled terminologies.
- Proficiency in SAS and at least one programming environment such as VB Scripts and JAVA.
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
Medical directors of Oncology Clinical Research New Jersey
Tanner and Associates is recruiting several Medical directors of Oncology Clinical Research for several large Biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey. Candidate can be based out of any of these locations.
Requirements:
Several Major Biotech companies are seeking Medical Director/Clinical Scientist with drug development experience to join the Oncology program. The candidate should have an M.D. with board certification/eligibility in hematology/oncology,or a Phd,PharmD with at least 5 years of drug development experience. Prior experience of clinical trials in an oncology related field is preferred. Candidates must be comfortable proactively solving issues and working independently.
Job Duties and Responsibilities are primarily focused, but not restricted to the design, implementation, analysis and interpretation of clinical trials from phase I-III. The candidate will be expected to make a significant contribution to the strategic direction of the Oncology programs, including clinical trial design, implementation, analysis, interpretation and dissemination of results as detailed below. In addition the candidate will be required to build and maintain excellent relationships with outside parties including clinical investigators and advisors, regulatory authorities and other Government institutions (eg NCI), and collaborating companies.
Responsibilities:
Design:
- Design of clinical experiments, including drafting of protocol summaries and providing clinical input to complete protocols
- Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings
- Serve as a key member on the Clinical SubTeam. Provide significant input into the clinical development/strategy
Implementation:
- As Medical Monitor, to be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines
- Partner with Data management for CRF and Tables, listings and figures design and data quality plan
- Medical monitoring of Phase I-III trials including serving as the primary Clinical Science contact on the Protocol Execution Teams(s) and the primary liaison for clinical operations and the primary point of contact for Medical Monitor inquiries from sites, monitors and CROs
- Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
Analysis and Interpretation:
- Analysis of interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the Company
Competencies:
- Excellent technical understanding of oncology
- Excellent technical understanding of the clinical trial process and in particular the role of the Medical Monitor, including compliance requirements, ICH, etc
- Excellent written and verbal communication skills
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—Southern California
Clinical Research Medical Director, Pulmonology—Southern California
Tanner and Associates is recruiting a Clinical Research Medical Director of Pulmonology for a worldwide Biotechnology company located in Southern California.
Responsibilities:
- Develops and executes medical strategies for Asthma molecules.
- Provides medical support during development of Asthma molecules, especially during Phase II.
- Leads 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. Will serve as the primary medical monitor on assigned projects.
Qualifications:
- MD with 2 or more years of clinical research and/or basic science experience research.
Preferences:
- 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.
- Ability in leading, managing and motivating a staff.
- Clinical research experience in the biopharmaceutical industry (Biotech, Pharmaceutical or CRO).
- 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.
- Demonstrated ability to serve as a medical expert in a complex matrix environment.
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
Senior Global Clinical Auditor—New Jersey
Senior Global Clinical Auditor—New Jersey
Tanner and Associates is recruiting a Senior Global Clinical Auditor for a Pharmaceutical company based out of New Jersey.
Responsibilities:
- Conducts global GCP audits of clinical studies, Protocols, Medical Research Reports and suppliers
- Assesses compliance of clinical investigations and internal processes
- Manages clinical study site and supplier audit activities for key drug compounds on a regional and trans-regional basis.
- Interacts with Study Managers to develop and refine audit plans
- Interacts with Global Study Audit Manager to track and complete audit plan.
- Develops audit tools, reviews draft of audit reports, and prepares and distributes the Study Audit Summary Report
- Leads Global System Audit teams to develop, conduct, and report results to the Global Functional Heads.
- Improves processes for Development & Compliance and Clinical Pharmacology audit metrics.
- Leads regulatory inspection activities and serves as an inspection committee member
- Provides interpretation and guidance for internal and external customers on clinical quality regulations/guidelines (FDA, ICH, EU, etc.)
- Supports development and refinement of the Global Quality System by participating in SOP authorship.
- Conducts training on the audit process for internal and external customers
- 40-50% international travel
Requirements:
- BS in biomedical science or equivalent with 8 years pharmaceutical industry experience; or, a MS in biomedical science or equivalent with 5 years of pharmaceutical industry experience.
- Minimum of 5 years of clinical research experience and 2-3 years of GCP auditing experience.
- Knowledge and experience of GCP requirements
- Familiar with computerized clinical data collection systems and biomedical statistics
- Proven project management skills including effective planning and organizational skills.
- Must be willing to travel approximately 40-50% to North America, Latin America, Australia and elsewhere
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
