Samumed

  • San Diego, CA
Samumed San Diego, CA
Jan 23, 2020
Clinical Biospecimen Manager San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Clinical Biospecimen Manager to oversee and implement biomarker strategic objectives as directed by the Translational Science Director, including oversight of clinical biospecimen sample quality, biomarker administrative needs (budget, presentations and study documents), continuous process improvement, and vendor engagement. This role is responsible for biomarker sample logistics within clinical trials from study start up through final close out visit, ensuring that all regulatory and organizational requirements are met. This is a full-time position in the company’s San Diego headquarters. Specific Responsibilities Functioning as key point of contact with external commercial or academic clinical laboratories with oversight responsibilities for agreements, work plans, budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality Assisting Translational Science Director in the oversight, management and implementation of the translational biomarker clinical plan Working with clinical scientists, clinical operations, data management and other functions to support sample management, sample handling and processing steps as described in the clinical trial laboratory manual Providing technical support for selection, qualification and periodic audits of CRO and academic laboratories supporting clinical trial biomarker assays Preparing study related documents, tracking samples and assisting team with queries, site training, and sample destruction Maintaining up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance and compliance Requirements A BS/MS with 5+ years of biopharmaceutical industry or clinical laboratory experience in biomarker assay development, assay validation and implementation within clinical trials, employing a broad range of platform technologies (e.g. NGS, Nanostring, IHC/IF, flow cytometry, other cell based and circulating biomarker technologies) Knowledge and understanding of clinical research, ICH, GCP, GLP, data management, and regulatory and legal issues related to clinical sample management Experience with biomarker development/translational research Basic understanding/expertise in oncology, neuroscience, or inflammation-related drug development Proven ability to collaborate in a team environment and work independently Excellent oral and written communication skills Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment   Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 23, 2020
Director, Clinical Science San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated individual to contribute to clinical science related activities as part of the Clinical Development function.   The position will provide broad scientific and/or medical input to activities that span across the scope of clinical development, including clinical protocol development, study implementation, analysis and reporting of results and support of externally facing groups, including Business Development, Commercial, and Medical Affairs. In collaboration with various corporate functions including Regulatory Affairs, Clinical Operations, and Clinical Outcomes and Analytics, contribute to efforts to produce high quality documents in support of regulatory filings (clinical study reports, briefing books, INDs, and NDAs) for Samumed development programs. Experience with patient‑reported outcome measure development and validation is desirable. This is a full-time position in the company’s San Diego headquarters. Requirements Master’s degree in a scientific discipline; Ph.D., Pharm D., M.D. in a related field preferred with 10 years or more direct biotechnology or pharmaceutical industry experience in Clinical Development or related areas Experience in multiple therapeutic areas, with prior experience in pain, musculoskeletal conditions, neurology, and/or oncology preferred Prior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents.  Excellent oral and written communication skills Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 23, 2020
Clinical Bioinformatics, Senior Manager/Associate Director San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Clinical Bioinformatics Scientist to join our Translational Science group to develop and implement computational approaches that translate findings from multi-omic clinical trial data, external database mining and internal transcriptomic studies into therapeutic hypotheses to further elucidate Samumed compounds’ mechanism of action, identify opportunities for patient stratification, and support indication selection. This is a full-time position in the company’s San Diego headquarters. Specific Responsibilities Analyzing clinical and translational patient data from Samumed clinical trials to identify patterns and biomarkers of response Mining publicly available and proprietary oncology-focused genomic databases to develop novel insights and generate new hypotheses Interpreting results and building tools to facilitate the effective communication and exploration of data to internal scientific and clinical teams Communicating and reporting genetic findings and analyses with colleagues, collaborators and through peer-reviewed publication Surveying the latest developments in the broader genetics community and incorporating relevant approaches for internal studies Participating in project teams with Samumed scientists and external collaborators and having an impact on the treatment of patients Requirements PhD or advanced degree in Bioinformatics/Computational Biology with 4+ years of relevant experience in biopharmaceutical industry or academia Data science skills to collect, integrate, mine and analyze complex biological data and translate them into testable hypotheses Experience in analysis of large-scale multi-omics data such as RNA-seq, whole-exome seq, functional genomics and pharmacogenomics data analyses Advanced knowledge in cancer genomics, immunology and molecular biology Experience in mining and analysis of public oncology genomic databases, such as TCGA, cBioPortal, etc.. Experience developing software within the Linux environment Strong programming capabilities in scripting languages (Python, Javascript) and proficient with Java or C++. Expertise with R and statistical analysis strongly desired Previous experience with machine learning methods and multivariate statistics particularly around biological data Strong skillset in Python + SciKit-Learn, PyTorch highly desirable. Experience writing and optimizing SQL for Oracle/MySQL/Postgres databases and strong understanding of relational databases. Experience with NoSQL databases a plus. Ability to multitask, work independently, and execute in a dynamic organization Strong skills in synthesizing data, and effectively communicating complex ideas to a broad scientific audience Proven ability to collaborate in a team environment and work independently Excellent oral and written communication skills Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 23, 2020
Study Physician San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Study Physician to provide therapeutic area expertise and have Medical Monitoring responsibility for Samumed clinical studies. The position will provide medical oversight and be a key contributor to activities that span across the scope of clinical development, including clinical protocol development, study implementation, monitoring, analysis and reporting of results. In collaboration with various corporate functions including Regulatory Affairs, Clinical Operations, and Clinical Outcomes and Analytics, contribute to efforts to produce high quality documents in support of regulatory filings (clinical study reports, briefing books, INDs, and NDAs) for Samumed development programs. This is a full-time position in the company’s San Diego headquarters. Requirements M.D. from a recognized school of medicine At least 2 years Medical Monitoring responsibilities at a biotechnology or pharmaceutical company Experience in multiple therapeutic areas, with prior experience in pain, musculoskeletal conditions, neurology, and/or oncology preferred Prior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents preferred.  Excellent oral and written communication skills Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 22, 2020
Manager / Associate Director, Medical Affairs Operations San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Manager or Associate Director, Medical Affairs Operations to join our Medical Affairs department. This position is responsible for planning, tracking, and driving timely execution of high-quality, integrated, medical, clinical and cross-functional projects / activities in support of Medical Affairs deliverables, including publications, congresses, medical field activities and advisory boards. This position facilitates routine, open interactions with team leaders, team representatives, and senior management. Working within a fast-paced, complex, multi-therapy area (TA) environment, this role requires consummate organizational, matrix leadership and inter-personal skills. Specific title will be dependent upon experience. This is a full-time position in the company’s San Diego headquarters. Specific Responsibilities Congresses: Working with Medical Therapeutic Area leads and Marketing executives to ensure coordination of medical deliverables, including booth medical resources, presentations, and meeting coordination. Supporting final report development. Attendance at major congresses may be necessary Medical advisory boards: Supporting accountable team to deliver advisory boards / meetings. Specifically coordinating venue selection and price negotiations, KOL management (contracts and correspondence), admin staff management (supervising KOL travel and expenses support), and final report development Medical Science Liaison field team support: Launch excellence, CRM, SOPs, training. Support Medical and Scientific publications management, including production of abstracts, posters, oral presentations and manuscripts to strict deadlines Assisting in the development of Medical Information and Medical Education teams, as well as departmental strategic planning Requirements Advanced degree (MS, PhD or PharmD) preferred. Candidates with additional relevant experience and a proven track record in successful clinical drug development will also be considered Project management experience and 2 years leading cross-functional teams Minimum 5 years of drug development experience is required (pharma, biotech, CRO), preferably crossing more than 1 functional area. Product launch experience preferred Proficient in MS Office software Excellent verbal and written communication skills Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 22, 2020
Legal Assistant, Legal Department San Diego, CA Samumed is looking for a talented and motivated individual to join its legal department as a Legal Assistant, Legal Department.  This is a fulltime position with full benefits and wages commensurate with experience.  The title will depend on a candidate’s experience. Specific Responsibilities Coordinating legal request workflow Preparing execution copies of contracts and obtaining necessary signatures Assisting with the review of legal documents, including confidentiality agreements, clinical trial agreements, and consulting agreements    Tracking various legal agreements and obligations and inputting critical information concerning same into appropriate databases Organizing and maintaining legal records and files, as needed Assisting with other routine administrative tasks, as needed Requirements Bachelor of Arts or Bachelor of Science degree Must be proficient in Microsoft Office including, Outlook, Word, Excel and PowerPoint Adobe Acrobat experience a plus Must have strong attention to detail and organization and communication skills Prior legal assistant experience is not required Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 04, 2020
Clinical Data Analyst, Clinical Data Management San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Clinical Data Analyst to join our Clinical Data Management (CDM) team to help with the creation and maintenance of clinical databases. This opportunity involves collaborating with others to effectively and efficiently perform data oversight activities. This position is expected to proactively identify and undertake data-related problems and propose solutions. This is a full-time position in the company’s San Diego headquarters or its satellite Dallas office. Specific Responsibilities Performing all aspects of the data cleaning process, with a high degree of accuracy and in accordance with Good Clinical Practices and Standard Operating Procedures, that include but are not limited to data listing reviews and third-party vendor data reconciliation Supporting the Project lead where necessary with database testing and development, vendor/data management, and internal document creation and maintenance Working in tandem with the CDM team to develop a standardization of design, documentation, testing, and implementation of clinical data collection (i.e., CRF standards), and clinical database review Providing input and review of Data Management Plans, eCRF Completion Guidelines, and Manual Review Listing Plans Query management from functional group listing and data reviews followed by oversight of proper site update and/or response and appropriate application of internal query guidelines Assisting with organizing data reviews and issue management from internal, cross-functional and central monitoring reviews Requirements College degree(s) in Life Sciences, Computer Science or Business preferred 2-3 years of relevant clinical experience in a Pharmaceutical, Biotech or CRO environment preferred GCP and regulatory knowledge including FDA and ICH regulations A flexible attitude with respect to work assignments and continued industry related education Efficiently organizes workload of several simultaneous studies to ensure critical milestones are met, while also maintaining an expectation of quality work Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously Ability to handle even difficult situations professionally and maintain a professional and caring demeanor Proven ability to collaborate in a team environment and work independently Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Jan 04, 2020
Associate Project Lead / Project Lead / Senior Project Lead, Clinical Data Management San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Associate Project Lead,  Project Lead, or Senior Project Lead to join our Clinical Data Management (CDM) team to help develop standards to increase efficiencies, implement process improvements, collaborate with cross-functional teams, and participate in the conduct of data management activities across all phases of clinical trials. The specific title will be dependent upon experience.  This is a full-time position in the company’s San Diego headquarters or its Dallas satellite office.  Specific Responsibilities Working in tandem with the CDM team and cross-functional team members to develop a standardization of design, documentation, testing, implementation of clinical data collection (i.e., CRF standards), training, and clinical database review Translating clinical protocols to database specifications that serve to ease site burden on entering data, as well as ensuring all necessary information for analysis is captured accurately Managing database development, maintenance, and lock, both in-house as well as when contracted with a CRO Providing creative and innovative strategies to data collection and standardization with both short-term and long-term departmental vision Serving as departmental contact for vendor relations, reconciliation, and transfer processes Working with the CDM team to create departmental SOPs that govern vendor relationships, clinical database development, and data upkeep Proactively identifying risks to timelines and data integrity, and manages appropriately Creating and applying standards in data cleaning, trend analysis and coordination of cross functional participation in data review Assisting in managing the workload of supportive data management team members to most efficiently resource time and tasks Requirements College degree(s) in Life Sciences, Computer Science, Business, or similar Bachelor degree or higher preferred 2-6 years of relevant clinical data management experience in a Pharmaceutical, Biotech or CRO environment Strong GCP and regulatory knowledge including FDA and ICH regulations Advanced ability to define problems, collect data, establish facts, and draw valid conclusions Ability to manage vendor relationships A flexible attitude with respect to work assignments and continued industry related education Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously Ability to handle even difficult situations professionally and maintain a professional and caring demeanor Proven ability to collaborate in a team environment and work independently Excellent oral and written communication skills Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed Chicago, Los Angeles, Cincinnati/Cleveland, Miami/Orlando, and Phoenix/Las Vegas
Jan 01, 2020
Commercial Liaison Chicago, Los Angeles, Cincinnati/Cleveland, Miami/Orlando, and Phoenix/Las Vegas We are seeking a responsible, dynamic, creative and highly motivated Commercial Liaison to join our commercialization team in the following cities: Chicago, Los Angeles, Cincinnati/Cleveland, Miami/Orlando, and Phoenix/Las Vegas The Commercial Liaison (CL) is responsible for the implementation of Samumed’s business strategies and plans calling on targeted health care providers (HCPs) in an assigned geography.   The CL will educate and inform providers and appropriate staff about the mechanism of action of Lorecivivint, currently in phase 3 trials, as a potential therapy for OA of the knee. The CL will be expected to engage and build relationships with clinical decision makers and staff to develop a deep understanding of the practice’s operations. The CL will identify challenges faced by the practice when treating OA using therapies administered under a patient’s medical benefit and provide potential solutions to appropriate internal teams.   The ongoing exchange between the National Sales Director (NSD), the CL, and provider community will be used internally to help create solutions for patients and inform cross functional efforts directed at product commercialization.  The ideal CL candidate will have led regional sales organizations from conception and thrives in an emerging company environment. The right person will be very comfortable rolling up his/her sleeves and doing for themselves many of the tasks often delegated to others in large companies.  Initial responsibilities Regionally, own targeted customer relationships and share insights with NSD, Marketing and Extended Commercial Team to help build OA franchise strategy Collaborate with Medical Affairs and Clinical Team to introduce Samumed’s science to specific institutions & HCPs Educate providers, including group practices, IDNs, and multi-specialty practices about the Wnt pathway and its potential as a multi-therapeutic platform using Samumed messages and materials Develop a strong understanding of the OA patient journey and what is needed to treat OA patients within the office setting Engage providers in dialogue to help determine the best go-to-market approach for future therapies Develop a collective, deep understanding of providers treating OA and use the knowledge to help cross-functional colleagues create impactful educational strategies and messages Identify emerging policies and trends that may impact Samumed strategies Compliantly manage all allocated resources, such as budgets and support materials Extended responsibilities upon successful completion of Phase 3 trials Hire an expanded team of experienced sales professionals that have a passionate commitment to help patients through the introduction of new science and new therapies Engage in the development of a best-in-class sales organization focused on innovation, delivering results and doing what is right for patients Align planning throughout sales organization to maximize execution of company and product strategy Finalize sales territories and call plans that maximize HCP engagement and product adoption Educate and socialize with the sales team a sales-professional development program that maximizes the potential of every sales team member Deliver exceptional product performance for novel therapies within assigned geography Requirements 5+ years track record of success in biopharmaceutical sales leadership, which must include Rheumatology and/ or Orthopedic channels 5+ years of successful experience in other functions such as field sales, product marketing, market access, sales operations, or training and development Demonstrated success in specialty product sales, preferably in Orthopedics and Rheumatology Examples of ability to lead with, or without direct authority Comprehensive understanding of reimbursement, distribution and access of injectable/infused products Must be fluent in the complexities and nuance of using “buy & bill” products Lead execution of clinical and business expertise and effective selling skills using all resources Proven ability to recruit best-in-class sales professionals. Develop, promote and retain high performing talent leading to a consistent track record of performance Demonstrated ability to manage performance Strong written and verbal communication skills Examples of developing and building a sense of esprit de corps throughout a sales region Significant travel (up to 50% of time) to provider locations, sales/company meetings, medical conferences, etc.  The position will be based within defined geographical region; must have valid Driver’s License Bachelor’s Degree required Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Dec 31, 2019
Director, Regulatory CMC San Diego, CA Samumed is looking for a Director Regulatory CMC to join our Regulatory Affairs team. The Director Regulatory CMC is responsible for providing the regulatory leadership for all development (and ultimately commercial) products, including CMC‑related regulatory strategy, application preparation and maintenance, and interaction with regulatory agencies. Specific Responsibilities Providing strategic guidance on global regulatory CMC requirements to senior management and cross-functional project teams Providing guidance to senior management, key stakeholders within CMC areas, and cross‑functional project teams on all regulatory issues for the strategic planning, development, risk assessment, and compilation of regulatory submissions Authoring or managing preparation of CMC‑focused regulatory submissions Leading CMC-related interactions and negotiations with regulatory agencies in all pertinent countries, during all stages of development and registration Serving as Regulatory CMC liaison with partner companies and contract manufacturers Partnering with Quality Assurance and Product Development to ensure regulatory submission accuracy and compliance Managing regulatory consultants and contractors Requirements Qualifications: Bachelor's or Master’s degree in life sciences (PharmD or PhD preferred) Minimum 10 years of Regulatory CMC experience in the biotech or pharmaceutical industry Familiarity with all pertinent regulations and guidances Experience with regulatory submissions (IND, CTA, NDA, MAA, etc.) in eCTD format Experience authoring/editing regulatory CMC and other technical documents Excellent written and oral communication and interpretive skills High attention to detail, and excellent proofreading and editing skills High‑level competence in pertinent software (e.g., Word, PowerPoint, EndNote) Good knowledge of the overall drug development process Experience with small molecule drug development is preferred Demonstrated ability in project management, with overlapping priorities and aggressive timelines Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA or Remote
Dec 29, 2019
Clinical Project Manager (CPM) San Diego, CA or Remote Samumed is currently looking for a talented and experienced CPM to join its team.  Remote work options are available for this position. Specific Responsibilities Managing timelines with MS Project for protocol; Managing vendors; Managing site monitoring; Authoring monitoring plans; Managing CRAs; Authoring pharmacy manuals; Leading investigator meeting and investigator meeting slide development; Providing overall site correspondence approval; Reviewing and tracking of trip reports for monitors; Training CRAs for protocol; Managing budget for protocol; Establishing special needs for protocol master files and audit schedule; Serving as primary contact for QA and DM for protocol; Participating in departmental planning sessions and SOP development; Co-monitoring Requirements 4 year life sciences or health care related degree Minimum 3 years of clinical project management experience Minimum 2 years of clinical monitoring experience Proficient in MS Office software Excellent verbal and written communication skills Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA or Remote
Dec 29, 2019
Clinical Research Associate II / Senior Clinical Research Associate (CRA II / Sr. CRA) San Diego, CA or Remote Samumed is currently looking for a talented and experienced CRA to join its team as a CRA II or Senior CRA, depending on experience level.  The CRA II / Sr. CRA participates in the planning, coordination, and monitoring activities of clinical trials in the Clinical Operations Department. The CRA II / Sr. CRA will provide project support in the initiation, execution and close out of assigned clinical studies.  Remote work options are available for this position.  Specific Responsibilities Providing clinical trial support, including preparation and management of administrative and regulatory documents, and preparation for monitoring visits Completing word processing, spreadsheet and database assignments, including, but not limited to, correspondence, records, reports, scanning, emailing, copying, filing and other tasks  Creating and managing Investigator Site File and ensuring that all documents within the file are complete Creating and maintaining contact lists and supportive documents for Clinical Development Department and for vendors Complying with institutional and departmental policies and procedures Independently monitoring and managing 8-10 clinical sites Co-monitoring/mentoring of more junior CRAs Assisting with vendor management and review of specifications Requirements 4 year life sciences or health care related degree Minimum 2 years of experience independent monitoring Proficient in MS Office software Excellent verbal and written communication skills Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Oct 02, 2019
Senior Formulation Scientist, CMC San Diego, CA Samumed is seeking a motivated and talented scientist to join the Formulation Development Group in the CMC department. The Formulation Scientist will be responsible for dosage form development and pre-formulation characterization of small molecule drug candidates. This individual will develop formulation strategies and timelines, provide technical leadership of formulation development and GMP manufacturing at contract manufacturing organizations (CMOs), and update multidisciplinary team with technical, timeline and budget issues. The position will be responsible for internal laboratory investigations and evaluation of new technologies that could advance Samumed programs. This is a full-time position in Samumed’s San Diego headquarters.  Specific Responsibilities Oversight of CMOs for process development, scale up and GMP manufacturing activities Authoring and review of written documents including development reports, technical memos, batch records, and relevant CMC sections for various regulatory filings, etc. Mentoring and supervising junior technical staff Serving as formulation lead in multidisciplinary project teams and/or sub-teams. Developing dosage forms for clinical and commercial use Developing stable and bioavailable formulations for different stages of development (e.g. solution/suspension-based formulations, parenterals, etc.) Generate data for project progression and regulatory filings, conduct optimization and process scale up studies Interpreting complicated, multidimensional data and make recommendation on new processes and development directions Transfer of technical knowledge to contract research sites (CRO) for onsite clinical preparations Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Samumed Requirements Ph.D in Chemistry, Pharmaceutical Sciences or related Physical Science and 6+ years of experience working in formulation development in the pharmaceutical or biotechnology industry or MS/BS with 10+ years of relevant formulation experience. Direct experience working with CMOs. Experience with enabling formulation development and scale up production is highly desired Experience working with small molecule new chemical entities (NCEs) and exposure to early phase formulation development activities. Experience with a range of dosage forms, including liquids, solids and oral. Proven experience managing the scale-up and manufacturing of pharmaceutical dosage forms. Experience with phase 3 & commercial manufacturing preferred. Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines. Excellent leadership, teamwork and organizational skills. Solid verbal and written communication skills. GLP, GMP, GxP experience. Motivated self-starter. Positive, adaptable, can-do attitude. Ability to travel and work flexible hours as required. Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Sep 03, 2019
Scientist I, Oncology (#2) San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Scientist to join our oncology team in the R&D division to contribute to preclinical research programs aimed at the development of treatments for cancer.   This position is a full-time position in the company’s San Diego headquarters. Specific Responsibilities Driving projects to rationally combine targeted therapies in in vitro and in vivo models of a variety of tumor types Developing functional immune cell-based assays including T cell activation and proliferation assays, tumor cell cytotoxicity assays and co-cultures with multiple cell types Designing and executing supporting assays (immunophenotyping, cytokine profiling, qPCR, ELISA and/or western-blot analysis) to assess target modulation levels and downstream effects Analyzing and documenting experimental data in electronic notebooks in a timely and accurate manner in accordance with the company rules Presenting scientific data in team meetings and assisting in the preparation of internal and external presentations (oral, posters, and publications). Requirements Ph.D. in Immunology, cancer biology or related field 2+ years post-graduate experience in immunology, tumor immunology or closely related field in industry.  Expertise in in vivo tumor models (i.e., xenograft, PDX) in both immunocompetent and immunocompromised mice Proficiency in functional immune cell-based assays (e.g., T cell activation and MLR assays) Expertise in multi-color flow cytometry, gene expression (qRT-PCR), western-blot Proficiency in isolation of PBMCs and tumor-infiltrating lymphocyte profiling in mouse syngeneic cancer models is highly desirable Proven ability to collaborate in a team environment and work independently Ability to design, plan, execute, interpret and troubleshoot experiments with minimal supervision Excellent oral and written communication skills Must have strong work ethic, able to multi-task, detail-oriented and enthusiastic for laboratory work Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Level will be commensurate with experience Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.
Samumed San Diego, CA
Sep 03, 2019
Medical Director, Oncology Clinical Scientist San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Medical Director, Oncology Clinical Scientist to join our Oncology Clinical Development program to work collaboratively with the members of the clinical development team to establish the clinical development plan(s) for one from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan, as well as to provide assessment of competitive landscape for strategic direction for clinical trial and non-clinical trial options and participate in strategic decisions related to clinical evidence to clinical development. Collaborates with various internal and external experts or agencies to assist in clinical/non-clinical strategy, the development of study designs, and scientific publications. This is a full-time position in the company’s San Diego headquarters. Specific Responsibilities Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation. May participate in regular review of individual subject safety data and performs review of cumulative safety data with the Medical Monitor/Medical Director In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators. May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues. May participate in due diligence activities such as due diligence reviews and reports Requirements Excellent oral and written communication skills Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment Degree in life sciences; Advanced scientific preferred (PhD, PharmD, MA); demonstrated experience in oncology drug development, early development preferred; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences); demonstrated scientific writing skills and good communication skills 7+ years in clinical development Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.