Samumed

  • San Diego, CA
Samumed San Diego, CA or Remote
Nov 06, 2019
Commercial Liaison San Diego, CA or Remote We are seeking a responsible, dynamic, creative and highly motivated Commercial Liaison to join our commercialization team.   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.  Remote options are available for this position.  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
Nov 06, 2019
Senior Director, Marketing, Musculoskeletal Franchise San Diego, CA We are seeking a responsible, dynamic, creative and highly motivated Senior Director of Marketing (SD-M) to lead our brand development and launch efforts for a novel, first-in-class therapy for osteoarthritis (OA), lorecivivint.   Reporting to the VP, Commercial Operations, the SD-M will develop our disease awareness campaign, and subsequently be responsible for all HCP and patient marketing activities associated with the launch of lorecivivint in the US.   He/she will lead agency partners and internal marketing teams through the development of the marketing strategy and program execution.   The SD-M will collaborate with the National Sales Director, the VP of Market Access, and our cross-functional teams across the organization to insure an exceptional launch. This is a full-time position in the company’s San Diego headquarters. Specific Responsibilities Lead the marketing strategy for an exceptional product launch for lorecivivint Develop and execute an integrated OA disease awareness campaign Identify and lead creation of US marketing tactics, including customer engagement and education, and materials development for all field teams Lead marketing team in creation and implementation of innovative educational and promotional programs for HCP, patients, and payers Plan and oversee the development of advertising materials and activities including print, online, and other personal and non-personal promotional efforts Serve as primary interface with all marketing agency partners for disease awareness campaign, brand creation and subsequent launch activities Optimize a marketing-mix-based budget and recommend product positioning, messaging and pricing strategy to senior commercial leadership team Collaborate with National Sales Director, OA to ensure educational, and subsequent promotional messaging implementation and highly actionable sales meetings Analyze customer insights and competitive dynamics to inform/adjust marketing/brand strategy and address customer needs Collaborate with Medical Affairs and Market Access colleagues to develop impactful/actionable messages for all stakeholders Lead and develop marketing team Continued contribution to build out commercial organization Requirements Bachelor’s degree required, and advanced degree (MBA, PharmD, etc.) preferred A 10+ year track record of innovation and effectiveness in pharmaceutical commercialization 6+ year track record of success in biopharmaceutical marketing 4+ years of successful experience in other functions such as sales, market access, sales operations, training and development, or finance. Demonstrated marketing success in specialty product sales, preferably in Orthopedics and Rheumatology Comprehensive understanding of reimbursement, distribution and access of injectable/infused products Must be fluent in the complexities and nuance of using products purchased and administered under a patient’s medical benefit Demonstrable success in creating successful commercial/marketing organizations Ability to hire, lead and develop best-in-class marketers Significant travel (up to 30% of time) to provider locations, sales/company meetings, medical conferences, etc. Strong written and verbal communication skills Demonstrated analytical and problem-solving skills Examples of ability to lead with, or without direct authority 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
Nov 06, 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 or Remote
Nov 06, 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
Nov 06, 2019
Analytical Development Scientist, CMC San Diego, CA Samumed is seeking a motivated and talented scientist to join the Analytical Development Group in the CMC department. The Analytical Scientist will be responsible for conducting complex chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples by internally developed and compendial test method. Tests methods will be transferred to partner contract manufacturing organizations (CMOs) and the analytical scientist will review the data for accuracy and complete technical result summaries. Drug product and drug substance methods will be developed for phase 1-3 and commercial. Experience providing oversight of analytical research outsourced to third party vendors is preferred. Specific Responsibilities Conducting chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples Verifying and processing analytical data Participating in the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, spectroscopy, and traditional quantitative analysis Maintaining and troubleshooting analytical instrumentation as needed Clearly and accurately communicating the results of work by creating documentation of the testing/analysis and obtained results. Recording and reporting analytical results in accordance with prescribed lab procedures and systems Maintaining and organizing work area, instrumentation, and testing materials. Performing all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines Collaborating with key CMOs to transfer analytical methods Tracking results from CMOs and generate summary reports, highlighting any OOS or trending results Requirements Bachelor’s degree in a physical science, with 3+ years of experience working in analytical development in the pharmaceutical or biotechnology industry. Excellent knowledge and understanding of chemistry and analytical instrumental technologies. Excellent knowledge of qualitative and quantitative chemical analysis. Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Excellent problem-solving skills and logical approach to solving scientific problems. Excellent proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development and validation). Excellent interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Motivated self-starter. Positive, adaptable, can-do attitude. Ability to work independently. Ability to travel and work flexible hours as required. 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
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
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.
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
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.