ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by
Overcoming Resistance In Cancer.
ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California.
Job Description
The Senior Vice President/Vice President, Regulatory Affairs, is responsible for developing and executing global regulatory strategies aimed at the most efficient regulatory pathway for ORIC's development programs. This position involves shaping and leading the long-term regulatory strategy and vision across all phases of development, providing oversight in planning product development strategies (including non-clinical, clinical, and post-approval), overseeing the company's development pipeline from preclinical through commercialization, interacting regularly with global regulatory authorities, overseeing global regulatory submissions across multiple regions, and building internal systems to support successful submissions of multiple IND/CTA/NDA/MAA/PMA applications.
Further, the Vice President, Regulatory Affairs, is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation, health authority regulations and guidances, and driving a culture of quality and accountability across the organization.
Provide oversight for global regulatory affairs in all major regions (North America, Europe, Asia Pacific, Latin America) for all regulatory functions, including Clinical, Non-clinical, Regulatory Operations, and broad oversight for Regulatory CMC and Regulatory Diagnostics
• Represent ORIC and act as a company spokesperson (or delegate with oversight) in communications with regulatory authorities
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
• Provide strategic input on all regulatory activities in support of product development plan, lifecycle management, and post-approval planning
• Supervise and develop regulatory direct reports
• Provide management with regulatory due diligence advice for potential new product opportunities
• Grow corporate, project and industry knowledge
• Analyze and communicate current Regulatory issues and information to senior management and other departmental personnel.
Qualifications
Advanced degree (PhD, PharmD, MD, or MS) in a life sciences or health-related discipline desired
At least 15 years of biopharma regulatory and quality experience, with 10+ years focused on oncology and late-stage development, including post-regulatory approval product launch experience
Previous experience directing and coordinating FDA and other Health Authority interactions
Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval
Experience with electronic filings (e.g., eCTD)
PERSONAL ATTRIBUTES:
Alignment with the company's core values: empowering employees, executing with excellence, embracing challenges, fostering inclusivity, remaining humble and hopeful, and maintaining a patient-centered focus
Additional Information
The anticipated salary range for candidates is between $300,000-$425,000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on
race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or
any other legally protected characteristic.
$300k-425k yearly 60d+ ago
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Vice President, Medical Affairs
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by
Overcoming Resistance In Cancer.
ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
ORIC is seeking a Vice President, Medical Affairs, as an initial member of the Global Medical Affairs (GMA) team based in the South San Francisco office. Reporting to the SVP of Medical Affairs and Commercial, this senior leader will be responsible for developing and executing the US and global GMA strategy and tactical plans with a focus on launch readiness and life cycle management for therapies across prostate cancer, non-small cell lung cancer (NSCLC), and potentially other tumor types. The VP will build and scale a high-performing GMA team while focusing on effectively analyzing and communicating key scientific data through publications, medical information, medical communications, and congress activities. The candidate must work collaboratively with cross-functional counterparts in Clinical Development and Operations, Regulatory, Research, Finance, Legal, and Commercial as well as other ORIC functional groups to design and implement a medical strategy for rinzimetostat in prostate cancer and enozertinib in NSCLC.
The ideal candidate will have pre- and post-launch experience in biotech/biopharma, is an experienced and collaborative leader, highly effective communicator, entrepreneurial, solutions-oriented, proactive, and scientifically driven.
Job Description
Key Responsibilities:
Build and lead the Global Medical Affairs (GMA) strategy and core capabilities in areas such as medical communications, operations, field medical, and a robust independent scientific research assessment process for all oncology assets.
Align medical strategy with corporate objectives, clinical development, regulatory, and commercial imperatives.
Build, mentor, and manage a high-performing Medical Affairs team, including Field Medical Science Liaisons (MSLs), Medical Information, Publications, and Evidence Generation.
Develop and execute the multi-year US and global medical strategy and plan for rinzimetostat and enozertinib, including activities related to scientific engagement and communication, internal education, and patient advocacy.
Work closely with the Clinical, Operations, CRO, and future MSL teams to provide recruitment, scientific, and engagement support to facilitate trial enrolment and conduct.
Drive Key Opinion Leader (KOL) engagement, advisory boards, and relationships with academic institutions, patient advocacy groups, and medical societies.
Lead integrated evidence planning, including clinical trial support, real-world evidence, and investigator-initiated studies.
Partner with Clinical Development, Regulatory Affairs, Market Access, and Commercial teams to ensure alignment of medical and business objectives.
Ensure all Medical Affairs activities comply with legal, regulatory, and corporate standards.
Manage operating budget, systems, processes, and future personnel efficiently to maximize ORIC resources.
Qualifications
An advanced medical/scientific degree: MD (preferred), PhD, or PharmD with a strong background in oncology.
Minimum 12-15+ years of experience in medical affairs, biotech and/or pharmaceutical industry with at least 5 years in a senior leadership role.
Must have a strong scientific background in oncology with deep understanding of biomarker-driven disease and ability to effectively analyze, synthesize, and communicate complex scientific information.
Proven leadership experience and track record in oncology product launches, lifecycle management, and building Medical Affairs capabilities.
Demonstrated ability to lead scientific engagement strategies and evidence generation programs and have familiarity with HEOR, expanded access programs, and global launch planning.
Strong networking skills with deep existing relationships and network with oncology healthcare professionals including global key opinion leaders.
Exceptional verbal, written, and presentation skills with the ability to effectively communicate complex scientific data to diverse audiences.
Ability to manage multiple priorities at one time with little direction and drive results in a fast-paced and dynamic environment.
Ability to thrive in a public, clinical-stage biotech environment with rapid growth and evolving priorities.
Ability to travel to South San Francisco and San Diego headquarters and to attend scientific congresses, trial related meetings, and key stakeholder meetings (domestic and some international) - up to 50% travel.
Manage and adhere to ORIC policies, ensuring compliance with corporate rules and government regulations.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $340,000-$380,000. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, degree type (MD vs. non-MD), title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$340k-380k yearly 26d ago
Associate Scientist II, Neuroscience
PTC Therapeutics 4.9
Mountain View, CA job
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: **************
Summary: The Associate Scientist II, Neuroscience is responsible for conducting scientific experiments that contribute to research and drug discovery activities at PTC. This position assists in the conduct of early-stage research, the goal of which is the identification of New Chemical Entities (NCEs), as well as the advancement of research programs from the identification of screening hits to advanced lead optimization. The incumbent is also responsible for communicating experimental results to his/her supervisor and the project team.
The Associate Scientist II, Neuroscience supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate.
.Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Under general guidance, executes experiments, interprets, and communicates results as part of multi-disciplinary team(s).
Applies relevant scientific principles and techniques to research problems.
Maintains detailed laboratory notebooks.
Maintains knowledge of state-of-the-art principles and techniques.
Ability to independently troubleshoot experiments -designing controls, generating interpretable data.
Presents findings internally and contributes to the publication of the work of the project team.
Contributes to the development of patent applications as appropriate.
Complies with all safety requirements.
Contributes to laboratory needs, such as stockroom maintenance and ordering supplies.
Involved in general lab duties as assigned.
Specific duties may also include, but may not be limited to, the following:
Assist in target deconvolution studies using a wide array of methodologies (including flow cytometry, ELISA, Western blot, RT-qPCR)
Executes weekly cell-based screening assays to support hit to lead optimization efforts for early-stage discovery programs.
Maintains multiple cell lines (thawing, passaging, seating) to support in vitro screening assays.
Routinely uploads and reports data in a timely fashion which may also include communicating any delays or changes in workflow to a cross-disciplinary team.
Provides support for the design and optimization of new assays, the goal of which is the identification of additional hits.
Profiles selected compounds to better understand compound mechanism of action in additional cells and tissues.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Experience with multi-color flow cytometry and immunophenotyping primary human cells.
Mammalian tissue culture experience with excellent sterile technique required.
Knowledge of basic Cell biology and Molecular biology
Exceptional attention to detail and time management skills
Strong analytical and problem-solving skills
* Minimum level of education and years of relevant work experience.
Bachelor's degree in a Biology scientific discipline, preferably Biology or Neuroscience or Immunology with a minimum of 6 years' experience, OR, Master's degree in a scientific discipline with a minimum of 2 years of relevant experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Demonstrates technical proficiency, and the ability to collaborate with others on cross functional teams in a fast-paced, matrixed, environment consisting of internal and external team members.
Possesses knowledge of scientific principles and concepts and keeps current with relevant scientific literature.
Proficiency with Microsoft Office- preferably MS Excel and MS PowerPoint.
Effective verbal and written communication and skills.
Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines.
Effective planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
Basic understanding of adaptive and innate immune system, especially as they relate to peripheral and nervous system inflammatory diseases.
Familiarity with establishing and routinely executing reproducible high-throughput assays
Proficiency with standard data analysis workflows, data visualization tools, and basic statistical analysis highly valued.
Knowledge of and ability to use standard molecular, cell biology, and immunology techniques.
Deep understanding in assay optimization and troubleshooting required.
* Travel requirements
Up to 5%
Office/Laboratory-based position
Expected Base Salary Range
$87,400 - $110,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
#LI-NM1
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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$87.4k-110k yearly Auto-Apply 60d+ ago
Director Information Technology, Development Operations
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in San Diego, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready.
Job Description
IT Business Partnership & Strategy
Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs.
Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives.
System Ownership & Implementation
Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS).
Gather application business requirements and systems goals from business owners and translate them into technical requirements.
Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo.
Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems.
Compliance & Validation
Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11.
Lead the IT GDPR compliance program.
Own CSV documentation and audit readiness for IT-supported platforms.
Inspection Readiness & Support
Partner with QA and Regulatory to prepare for health authority inspections.
Provide IT support during inspections, including system demonstrations and documentation.
Project & Change Management
Lead cross-functional projects from concept through deployment.
Manage change control processes and ensure stakeholder alignment.
Manage the UAT planning, execution, and reporting.
Qualifications
Bachelor's or Master's degree in Computer Science, Life Sciences, or related field.
8+ years of experience in IT supporting development functions in the biopharma industry.
Strong knowledge of Veeva Vault applications and their configuration.
Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance.
Familiarity with Phase 3 clinical trial operations and regulatory submission processes.
Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.).
Experience in R&D data domains and lifecycle.
Excellent communication, stakeholder management, and problem-solving skills.
Preferred Experience:
Experience supporting global clinical trials and regulatory submissions.
Prior involvement in inspection readiness or direct participation in regulatory audits.
Knowledge of Quality Management Systems (QMS).
Additional Information
The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$200k-250k yearly 59d ago
Research Associate II, Analytical Sciences (Contract)
Oric Pharmaceuticals, Inc. 4.5
Oric Pharmaceuticals, Inc. job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
We are seeking a highly motivated Research Associate II (Contractor) with a proven record of sustained laboratory achievement and innovation to join our growing PharmSci group at ORIC Pharmaceuticals. The selected candidate will provide lab support across various projects and teams; contribute to our shared mission of bringing new therapies to cancer patients.
Job Description
* Perform sample analysis using general laboratory techniques, such as weighing, pipetting, and operating laboratory instruments (HPLC, LC-MS, GC, UV-Vis, KF, dissolution apparatus, etc.).
* Execute analysis with a solid understanding of the test procedures, underlying science and proper instrument operation, ensuring accurate and reliable results.
* Utilize available software to control instruments, collect data, process and calculate results, and prepare comprehensive reports.
* Maintain precise and comprehensive records of all analyses in a lab notebook, ensuring compliance with company standards and promoting traceability and consistency in data reporting.
* Prepare test solutions, reagents, and samples for analysis, ensuring accuracy and strict adherence to written instructions and procedures.
* Prepare presentation materials and clearly communicate research results to manager, and at internal/external meetings.
* Work cross-functionally with Process Chemistry and Formulation Development colleagues.
Qualifications
* Requires a B.Sc. degree in chemistry with a minimum of 3 years of relevant research experience, or a M.Sc. degree with at least 1 year of hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
* Hands-on experience with laboratory techniques, including chromatography (e.g., HPLC, GC, LC/MS), spectroscopy (e.g., UV-Vis, FTIR), titration methods (e.g., Karl Fischer, acid-base), dissolution testing, particle size analysis (by laser diffraction), microscopy, and other compendial methods.
* Experience using laboratory software to collect, analyze, and report data. This might include instrument control software (Chemstation, Empower, etc.) or data analysis programs (Excel, etc.).
* Demonstrated ability to take initiative, ownership, problem identification, problem solving and input into experimental design aspects.
* A proven record of sustained laboratory achievement and innovation.
* Familiarity with industry guidelines such as ICH guidelines, USP requirements, FDA guidance, and good laboratory practices (GLP).
* Exceptional safety and organizational skills and attention to detail when handling samples, recording data, and preparing reports.
* Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment.
Additional Information
The anticipated salary range for candidates who will work on-site at our South San Francisco location is between $45.00-$50.00 per hour. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$45-50 hourly 3d ago
Senior Director/Director Business Development (oncology)
Oric Pharmaceuticals, Inc. 4.5
Oric Pharmaceuticals, Inc. job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
The Director/Senior Director, Business Development, is a strategic leader responsible for driving growth, forging key partnerships, and advancing the company's oncology pipeline. This broad role requires experience in oncology drug development, strong scientific and commercial acumen, and the ability to influence at all levels both internally and externally. The Director/Senior Director, Business Development, will report directly to ORIC's Chief Business Officer and be involved in all aspects of business development, including competitive intelligence, alliance management, search and evaluation, in-licensing, out-licensing, and commercial assessments. The Director/Senior Director, Business Development, is expected to work collaboratively across functions within the organization, represent ORIC to external partners, and play a pivotal role in executing our corporate strategy and mission in oncology.
Job Description
* Develop and maintain a comprehensive understanding of the company's oncology pipeline, R&D capabilities, and strategic objectives.
* Lead competitive intelligence and therapeutic area landscape assessments in prostate cancer and non-small cell lung cancer, providing actionable insights to cross-functional stakeholders.
* Build and manage strategic alliances with current and prospective partners in the oncology space, ensuring alignment with corporate goals.
* Stay abreast of industry trends and competitor activities in oncology to inform business development strategy.
* Support executive leadership in strategic planning, forecasting, and the development of presentation materials for internal and external audiences.
* Identify, evaluate, and recommend new business development opportunities, including in-licensing, out-licensing, partnerships, and M&A, with a focus on oncology assets.
* Oversee due diligence processes, including scientific, clinical, market, and financial analyses to support business cases for new oncology opportunities.
Qualifications
* Bachelor's degree in life sciences required; advanced degree (MBA, MS, MD, or PhD) preferred.
* 8-10+ years of biotechnology or pharmaceutical industry experience, with a proven track record in oncology business development, competitive intelligence, market research, and/or strategic partnerships.
* Excellent communication, presentation, and relationship-building abilities.
* Strong analytical, financial modeling, and project management skills.
Key Competencies
* Commercial, clinical and scientific acumen in oncology
* Strategic thinking and problem-solving in oncology drug development
* Influencing and negotiation with scientific, clinical and commercial partners
* Cross-functional collaboration (R&D, clinical, regulatory, commercial)
Oncology-Specific Focus Areas
* Deep understanding of oncology therapeutic landscapes. Experience with prostate cancer and/or non-small cell lung cancer desired.
* Experience with interpreting scientific data, analyzing clinical trial designs, understanding regulatory frameworks, and evaluating commercial opportunities for oncology therapies.
* Ability to assess and communicate the value proposition of oncology programs to internal and external stakeholders.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $250,000-$285,000 for the Senior Director and between $210,000-$260,000 for the Director. The final salary offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$250k-285k yearly 9d ago
Medical Director - Oncology
Fate Therapeutics, Inc. 4.5
San Diego, CA job
Fate Therapeutics is seeking a hands-on physician leader to serve as Medical Director within Fate's Clinical Development Group. This individual will contribute to the development and implementation of clinical strategies and may be responsible for the oversight of contracted personnel and or organizations to advance Fate's clinical program(s). They will also serve as a liaison between Fate and clinical investigators and will need to maintain established and productive relationships with key opinion leaders (KOL), as well as regulatory officials. The ideal candidate should have experience in solid and hematologic tumor oncology, with experience in the design and conduct of clinical studies in this therapeutic area. Experience with cellular therapies is desirable. This is a full-time exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities
* Provide clinical leadership of one or more programs across solid and hematological tumors.
* Design competitive clinical strategies and deliver effective and timely study protocols in collaboration with clinical investigators, key opinion leaders and regulatory agencies to meet Fate scientific and corporate objectives.
* Prepare study protocols, amendments, specific sections of study manuals, Investigator Meeting notebooks, and other documents with appropriate guidance and supervision.
* Contribute to start-up activities, including the design and development of CRFs, Data Management Manuals, and Data Analysis Plans.
* Address questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs.
* Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities.
* Assist in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
* Play a leading role in the development and implementation of communications strategies to support existing and concluded studies.
* May enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
* Consistently comply with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines.
* Maintain effective working relationships with team members to ensure scientific integrity of clinical studies.
* May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Qualifications
* MD degree with 5+ years of relevant scientific and/or drug development experience.
* 2+ years in clinical research in a pharmaceutical company, contract research organization, or academic institution is preferred.
* Experience in oncology is required.
* Demonstrated ability to be flexible and adaptable to change.
* Ability to form effective working relationships with internal and external parties including investigators, KOLs, Clinical Sites, etc.
* Outstanding written communication skills.
* Strong presentation skills; highly effective at summarizing and presenting the key considerations and decision-points.
Working conditions & physical requirements
* Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
* Travel may be required.
Compensation
* The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
* Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
* The anticipated salary range for this role is $280,000 - $310,000 + 20% annual target bonus.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy Notice
To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit *************************
️ Recruitment Fraud Alert
Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker's personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.
Here are a few things to be aware of to help identify recruitment fraud:
* Our Talent Acquisition team only corresponds from ************************* domain.
* At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.
* We will only ask for personal information when applying for a position via our Careers page or thereafter.
* At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.
* We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.
Please exercise caution. If something feels off about your interactions, we encourage you to contact us at [email protected] to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$280k-310k yearly 35d ago
Senior Manager/Manager, Manufacturing
Fate Therapeutics 4.5
San Diego, CA job
Fate Therapeutics is seeking a motivated and execution-driven Manager/Senior Manager to support GMP manufacturing operations of iPSC-derived allogenic cell therapy products. As an integral part of the Manufacturing Team, this role is responsible for overseeing operational execution in addition to managing manufacturing quality events including deviations, CAPAs, and other required change actions. This individual will play a pivotal role in defining and executing the company's operational strategy to enable the execution of a sustainable, scalable and GMP compliant manufacturing process. Accordingly, this role will require proven leadership abilities to drive meaningful communication, collaboration and coordination both internally within the Manufacturing department as well as cross-functionally across all levels of the organization. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA. Responsibilities
Responsible for overseeing end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCB's through harvest and cryopreservation of drug product.
Work effectively with other groups including Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, and Facilities.
Coordinate with applicable departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments and Change Actions.
Assure manufacturing facility is maintained in an inspection-ready state at all times.
Engage with Materials Management and Planning and Sourcing teams to assure adequate inventory of raw materials to support planned production activities.
Project management utilizing tools including but not limited to SmartSheet and Microsoft Office tools.
Assure manufacturing staff meet and maintain cGMP training requirements.
Develop personnel schedules to allow effective execution of manufacturing activities.
Review and approve applicable manufacturing-related documentation.
Lead authorship and review process of SOPs and GMP BRs.
Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes.
May hire, oversee, train, and motivate team members, ensuring that team goals are met efficiently.
Qualifications
Bachelor's or Master's degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience is required.
A strong manufacturing administration background specifically related to tech transfer of aseptically produced cell products is preferred.
A strong emphasis on quality event management and process improvement for manufacturing operations
Ability to create, read, review, and edit manufacturing related documents including Batch Records, SOP's, Work Instructions and associated forms.
Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment.
Experience leading projects and managing teams is required.
Working Conditions
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Will require working with cells and cell lines of human and/or animal origin.
Will require working with hazardous materials.
Will require work in controlled and cGMP Manufacturing environments requiring special gowning.
Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
The anticipated salary range for this role is $110,000 - $150,000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy NoticeTo learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit *************************
⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker's personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud:- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.- We will only ask for personal information when applying for a position via our Careers page or thereafter.- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at **************************** to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.
$110k-150k yearly Auto-Apply 60d+ ago
Director Information Technology, Development Operations
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in San Diego, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready.
Job Description
IT Business Partnership & Strategy
Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs.
Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives.
System Ownership & Implementation
Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS).
Gather application business requirements and systems goals from business owners and translate them into technical requirements.
Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo.
Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems.
Compliance & Validation
Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11.
Lead the IT GDPR compliance program.
Own CSV documentation and audit readiness for IT-supported platforms.
Inspection Readiness & Support
Partner with QA and Regulatory to prepare for health authority inspections.
Provide IT support during inspections, including system demonstrations and documentation.
Project & Change Management
Lead cross-functional projects from concept through deployment.
Manage change control processes and ensure stakeholder alignment.
Manage the UAT planning, execution, and reporting.
Qualifications
Bachelor's or Master's degree in Computer Science, Life Sciences, or related field.
8+ years of experience in IT supporting development functions in the biopharma industry.
Strong knowledge of Veeva Vault applications and their configuration.
Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance.
Familiarity with Phase 3 clinical trial operations and regulatory submission processes.
Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.).
Experience in R&D data domains and lifecycle.
Excellent communication, stakeholder management, and problem-solving skills.
Preferred Experience:
Experience supporting global clinical trials and regulatory submissions.
Prior involvement in inspection readiness or direct participation in regulatory audits.
Knowledge of Quality Management Systems (QMS).
Additional Information
The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$200k-250k yearly 29d ago
Research Associate II, Analytical Sciences (Contract)
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by
Overcoming Resistance In Cancer.
ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
We are seeking a highly motivated Research Associate II (Contractor) with a proven record of sustained laboratory achievement and innovation to join our growing PharmSci group at ORIC Pharmaceuticals. The selected candidate will provide lab support across various projects and teams; contribute to our shared mission of bringing new therapies to cancer patients.
Job Description
Perform sample analysis using general laboratory techniques, such as weighing, pipetting, and operating laboratory instruments (HPLC, LC-MS, GC, UV-Vis, KF, dissolution apparatus, etc.).
Execute analysis with a solid understanding of the test procedures, underlying science and proper instrument operation, ensuring accurate and reliable results.
Utilize available software to control instruments, collect data, process and calculate results, and prepare comprehensive reports.
Maintain precise and comprehensive records of all analyses in a lab notebook, ensuring compliance with company standards and promoting traceability and consistency in data reporting.
Prepare test solutions, reagents, and samples for analysis, ensuring accuracy and strict adherence to written instructions and procedures.
Prepare presentation materials and clearly communicate research results to manager, and at internal/external meetings.
Work cross-functionally with Process Chemistry and Formulation Development colleagues.
Qualifications
Requires a B.Sc. degree in chemistry with a minimum of 3 years of relevant research experience, or a M.Sc. degree with at least 1 year of hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
Hands-on experience with laboratory techniques, including chromatography (e.g., HPLC, GC, LC/MS), spectroscopy (e.g., UV-Vis, FTIR), titration methods (e.g., Karl Fischer, acid-base), dissolution testing, particle size analysis (by laser diffraction), microscopy, and other compendial methods.
Experience using laboratory software to collect, analyze, and report data. This might include instrument control software (Chemstation, Empower, etc.) or data analysis programs (Excel, etc.).
Demonstrated ability to take initiative, ownership, problem identification, problem solving and input into experimental design aspects.
A proven record of sustained laboratory achievement and innovation.
Familiarity with industry guidelines such as ICH guidelines, USP requirements, FDA guidance, and good laboratory practices (GLP).
Exceptional safety and organizational skills and attention to detail when handling samples, recording data, and preparing reports.
Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment.
Additional Information
The anticipated salary range for candidates who will work on-site at our South San Francisco location is between $45.00-$50.00 per hour. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$45-50 hourly 2d ago
Executive/Senior Director, Medical Affairs
Oric Pharmaceuticals, Inc. 4.5
Oric Pharmaceuticals, Inc. job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
ORIC Pharmaceuticals is seeking a Senior/Executive Director, Medical Affairs, as an initial member of the Global Medical Affairs (GMA) team based in ORIC's South San Francisco office. Reporting to the Head of Medical Affairs, this individual will be responsible for developing and executing the GMA strategy and tactical plans with a focus on launch readiness and life cycle management for therapies across prostate cancer, non-small cell lung cancer (NSCLC), and potentially other tumor types. The successful candidate will have a proven track record of developing and driving medical strategy for multiple assets with a focus on effectively analyzing and communicating key scientific data through publications, medical information, medical communications, congress activities as well as gathering insights through advisory boards, advocacy, and Key Opinion Leader (KOL) relationships. The candidate must work collaboratively with cross-functional counterparts in Clinical Development and Operations, Regulatory, Research, Finance, Legal, and Commercial as well as other ORIC functional groups to design and implement a medical strategy for rinzimetostat in prostate cancer and enozertinib in NSCLC.
The ideal candidate will have background experience in biotech/biopharma, during both pre-launch and post-launch product phases, is an experienced and collaborative leader, highly effective communicator, entrepreneurial, solutions-oriented, proactive, and scientifically driven.
Job Description
Key Responsibilities:
* Build and lead key Global Medical Affairs (GMA) capabilities in areas such as medical communications, operations, field medical, and a robust independent scientific research assessment process.
* Facilitate the development and execution of the multi-year US and global medical strategy and plan for rinzimetostat and enozertinib, including activities related to scientific engagement and communication, internal education, and patient advocacy.
* Lead integrated evidence generation planning in prostate, NSCLC and other disease areas of interest, including development/refinement of a publication strategy/plan, an evidence/RWD generation plan, and tactical plan as part of the overall GMA plan.
* Provide medical leadership in scientific engagement activities with key stakeholders through organizing and leading advisory boards, investigator interactions, congress activities, educational presentations and peer-to-peer discussions with the goal of exchanging and communicating scientific insights to internal teams to drive strategy.
* Lead the operations and oversight of medical affairs activities in key therapeutic areas while working cross-functionally with multiple functional leaders to support pre-launch/launch activities, and provide regular updates and support to management.
* Develop and execute a strategic plan for key opinion leader outreach and insights generation by proactively establishing and maintaining strong relationships with thought leaders, academic institutions, advocacy and medical societies in the field of oncology.
* Work closely with the Clinical, CRO, and future MSL teams to provide recruitment, scientific, and engagement support to facilitate clinical trial enrolment and timelines.
* Lead Patient Advocacy strategy and planning to incorporate the patient voice and define external medical education strategies for independent grants, respectively.
* Support competitive intelligence team activities through landscape assessments, development of patient journey, and congress insights.
* Provide medical support for scientific symposia and medical congresses and collaborate across functions to develop, review, and align on key scientific communication points, educational tactics, and medical information response documents within legal and compliance guidelines.
* Support the review and approval of abstracts, manuscripts, posters, presentations, and other documents as well as internal stakeholder medical education activities
* Provide medical strategy leadership for Expanded Access Programs (EAP) and Investigator-Initiated Studies (IIS).
* Manage operating budget, systems, processes, and future personnel efficiently to maximize ORIC resources.
Qualifications
Qualifications/Requirements:
* An advanced medical/scientific degree (MD, PhD, NP/PA, or PharmD) with a strong background in oncology.
* 10+ years of experience in medical affairs, biotech and/or pharmaceutical industry with at least 5 years in a senior leadership role.
* Must have a strong scientific background in oncology with deep understanding of biomarker-driven disease and ability to effectively analyze, synthesize, and communicate complex scientific information.
* Strong networking skills with deep existing relationships and network with oncology healthcare professionals including global key opinion leaders.
* Previous overall responsibility and accountability for medical affairs activities, including budget management for more than one compound (pipeline and marketed).
* Hands-on experience executing direct US and global activities of various functions within medical affairs (training, medical communications, medical information, EAP, evidence generation, publications, etc.).
* Proven track record of clinical trial support including protocol development/review, site selection support, enrollment support, and data analysis.
* Extensive experience in product launches including integrated brand plan ideation, regulatory submissions, label development, patient access and reimbursement.
* Exceptional verbal, written, and presentation skills with the ability to effectively communicate complex scientific data to diverse audiences.
* Ability to manage multiple priorities at one time with little direction and drive results in a fast-paced and dynamic environment.
* Ability to travel to South San Francisco and San Diego headquarters and to attend scientific congresses, trial related meetings, and key stakeholder meetings (domestic and some international) - up to 50% travel.
* Manage and adhere to ORIC policies, ensuring compliance with corporate rules and government regulations.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $300,000-$340,000. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, degree type (MD vs. non-MD), title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$300k-340k yearly 27d ago
Medical Director - Oncology
Fate Therapeutics, Inc. 4.5
San Diego, CA job
Fate Therapeutics is seeking a hands-on physician leader to serve as Medical Director within Fate's Clinical Development Group. This individual will contribute to the development and implementation of clinical strategies and may be responsible for the oversight of contracted personnel and or organizations to advance Fate's clinical program(s). They will also serve as a liaison between Fate and clinical investigators and will need to maintain established and productive relationships with key opinion leaders (KOL), as well as regulatory officials. The ideal candidate should have experience in solid and hematologic tumor oncology, with experience in the design and conduct of clinical studies in this therapeutic area. Experience with cellular therapies is desirable. This is a full-time exempt position located at our corporate headquarters in San Diego, CA.Responsibilities
Provide clinical leadership of one or more programs across solid and hematological tumors.
Design competitive clinical strategies and deliver effective and timely study protocols in collaboration with clinical investigators, key opinion leaders and regulatory agencies to meet Fate scientific and corporate objectives.
Prepare study protocols, amendments, specific sections of study manuals, Investigator Meeting notebooks, and other documents with appropriate guidance and supervision.
Contribute to start-up activities, including the design and development of CRFs, Data Management Manuals, and Data Analysis Plans.
Address questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs.
Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities.
Assist in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
Play a leading role in the development and implementation of communications strategies to support existing and concluded studies.
May enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
Consistently comply with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines.
Maintain effective working relationships with team members to ensure scientific integrity of clinical studies.
May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Qualifications
MD degree with 5+ years of relevant scientific and/or drug development experience.
2+ years in clinical research in a pharmaceutical company, contract research organization, or academic institution is preferred.
Experience in oncology is required.
Demonstrated ability to be flexible and adaptable to change.
Ability to form effective working relationships with internal and external parties including investigators, KOLs, Clinical Sites, etc.
Outstanding written communication skills.
Strong presentation skills; highly effective at summarizing and presenting the key considerations and decision-points.
Working conditions & physical requirements
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Travel may be required.
Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
The anticipated salary range for this role is $280,000 - $310,000 + 20% annual target bonus.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy NoticeTo learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit *************************
⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker's personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud:- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.- We will only ask for personal information when applying for a position via our Careers page or thereafter.- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at **************************** to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$280k-310k yearly Easy Apply 4d ago
Senior Director/Director Business Development (oncology)
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by
Overcoming Resistance In Cancer.
ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
The Director/Senior Director, Business Development, is a strategic leader responsible for driving growth, forging key partnerships, and advancing the company's oncology pipeline. This broad role requires experience in oncology drug development, strong scientific and commercial acumen, and the ability to influence at all levels both internally and externally. The Director/Senior Director, Business Development, will report directly to ORIC's Chief Business Officer and be involved in all aspects of business development, including competitive intelligence, alliance management, search and evaluation, in-licensing, out-licensing, and commercial assessments. The Director/Senior Director, Business Development, is expected to work collaboratively across functions within the organization, represent ORIC to external partners, and play a pivotal role in executing our corporate strategy and mission in oncology.
Job Description
• Develop and maintain a comprehensive understanding of the company's oncology pipeline, R&D capabilities, and strategic objectives.
• Lead competitive intelligence and therapeutic area landscape assessments in prostate cancer and non-small cell lung cancer, providing actionable insights to cross-functional stakeholders.
• Build and manage strategic alliances with current and prospective partners in the oncology space, ensuring alignment with corporate goals.
• Stay abreast of industry trends and competitor activities in oncology to inform business development strategy.
• Support executive leadership in strategic planning, forecasting, and the development of presentation materials for internal and external audiences.
• Identify, evaluate, and recommend new business development opportunities, including in-licensing, out-licensing, partnerships, and M&A, with a focus on oncology assets.
• Oversee due diligence processes, including scientific, clinical, market, and financial analyses to support business cases for new oncology opportunities.
Qualifications
• Bachelor's degree in life sciences required; advanced degree (MBA, MS, MD, or PhD) preferred.
• 8-10+ years of biotechnology or pharmaceutical industry experience, with a proven track record in oncology business development, competitive intelligence, market research, and/or strategic partnerships.
• Excellent communication, presentation, and relationship-building abilities.
• Strong analytical, financial modeling, and project management skills.
Key Competencies
• Commercial, clinical and scientific acumen in oncology
• Strategic thinking and problem-solving in oncology drug development
• Influencing and negotiation with scientific, clinical and commercial partners
• Cross-functional collaboration (R&D, clinical, regulatory, commercial)
Oncology-Specific Focus Areas
• Deep understanding of oncology therapeutic landscapes. Experience with prostate cancer and/or non-small cell lung cancer desired.
• Experience with interpreting scientific data, analyzing clinical trial designs, understanding regulatory frameworks, and evaluating commercial opportunities for oncology therapies.
• Ability to assess and communicate the value proposition of oncology programs to internal and external stakeholders.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $250,000-$285,000 for the Senior Director and between $210,000-$260,000 for the Director. The final salary offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$250k-285k yearly 8d ago
Senior Director/ Director, CMC Regulatory Affairs
Oric Pharmaceuticals, Inc. 4.5
Oric Pharmaceuticals, Inc. job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC's clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.
Job Description
* Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC's products.
* Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
* Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
* Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
* Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
* Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
* Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
* Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
Qualifications
* BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
* At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
* Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
* Experience in addressing CMC-related regulatory queries from global health authorities.
* Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
* Demonstrated success driving drug product development and managing all aspects of CMC documentation.
* Excellent working knowledge and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
* Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
* Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
* Excellent attention to detail, and strong computer and organizational skills required.
* Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
* Must have a quality mindset and deliver results in an ethical and positive manner.
* Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
* Proven ability to manage multiple tasks and associated deadlines.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 for the Director level and $250,000-$300,000 for Senior Director, level candidates . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$250k-300k yearly 37d ago
Vice President, Medical Affairs
Oric Pharmaceuticals, Inc. 4.5
Oric Pharmaceuticals, Inc. job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
ORIC is seeking a Vice President, Medical Affairs, as an initial member of the Global Medical Affairs (GMA) team based in the South San Francisco office. Reporting to the SVP of Medical Affairs and Commercial, this senior leader will be responsible for developing and executing the US and global GMA strategy and tactical plans with a focus on launch readiness and life cycle management for therapies across prostate cancer, non-small cell lung cancer (NSCLC), and potentially other tumor types. The VP will build and scale a high-performing GMA team while focusing on effectively analyzing and communicating key scientific data through publications, medical information, medical communications, and congress activities. The candidate must work collaboratively with cross-functional counterparts in Clinical Development and Operations, Regulatory, Research, Finance, Legal, and Commercial as well as other ORIC functional groups to design and implement a medical strategy for rinzimetostat in prostate cancer and enozertinib in NSCLC.
The ideal candidate will have pre- and post-launch experience in biotech/biopharma, is an experienced and collaborative leader, highly effective communicator, entrepreneurial, solutions-oriented, proactive, and scientifically driven.
Job Description
Key Responsibilities:
* Build and lead the Global Medical Affairs (GMA) strategy and core capabilities in areas such as medical communications, operations, field medical, and a robust independent scientific research assessment process for all oncology assets.
* Align medical strategy with corporate objectives, clinical development, regulatory, and commercial imperatives.
* Build, mentor, and manage a high-performing Medical Affairs team, including Field Medical Science Liaisons (MSLs), Medical Information, Publications, and Evidence Generation.
* Develop and execute the multi-year US and global medical strategy and plan for rinzimetostat and enozertinib, including activities related to scientific engagement and communication, internal education, and patient advocacy.
* Work closely with the Clinical, Operations, CRO, and future MSL teams to provide recruitment, scientific, and engagement support to facilitate trial enrolment and conduct.
* Drive Key Opinion Leader (KOL) engagement, advisory boards, and relationships with academic institutions, patient advocacy groups, and medical societies.
* Lead integrated evidence planning, including clinical trial support, real-world evidence, and investigator-initiated studies.
* Partner with Clinical Development, Regulatory Affairs, Market Access, and Commercial teams to ensure alignment of medical and business objectives.
* Ensure all Medical Affairs activities comply with legal, regulatory, and corporate standards.
* Manage operating budget, systems, processes, and future personnel efficiently to maximize ORIC resources.
Qualifications
* An advanced medical/scientific degree: MD (preferred), PhD, or PharmD with a strong background in oncology.
* Minimum 12-15+ years of experience in medical affairs, biotech and/or pharmaceutical industry with at least 5 years in a senior leadership role.
* Must have a strong scientific background in oncology with deep understanding of biomarker-driven disease and ability to effectively analyze, synthesize, and communicate complex scientific information.
* Proven leadership experience and track record in oncology product launches, lifecycle management, and building Medical Affairs capabilities.
* Demonstrated ability to lead scientific engagement strategies and evidence generation programs and have familiarity with HEOR, expanded access programs, and global launch planning.
* Strong networking skills with deep existing relationships and network with oncology healthcare professionals including global key opinion leaders.
* Exceptional verbal, written, and presentation skills with the ability to effectively communicate complex scientific data to diverse audiences.
* Ability to manage multiple priorities at one time with little direction and drive results in a fast-paced and dynamic environment.
* Ability to thrive in a public, clinical-stage biotech environment with rapid growth and evolving priorities.
* Ability to travel to South San Francisco and San Diego headquarters and to attend scientific congresses, trial related meetings, and key stakeholder meetings (domestic and some international) - up to 50% travel.
* Manage and adhere to ORIC policies, ensuring compliance with corporate rules and government regulations.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $340,000-$380,000. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, degree type (MD vs. non-MD), title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$340k-380k yearly 26d ago
Medical Director - Oncology
Fate Therapeutics 4.5
San Diego, CA job
Fate Therapeutics is seeking a hands-on physician leader to serve as Medical Director within Fate's Clinical Development Group. This individual will contribute to the development and implementation of clinical strategies and may be responsible for the oversight of contracted personnel and or organizations to advance Fate's clinical program(s). They will also serve as a liaison between Fate and clinical investigators and will need to maintain established and productive relationships with key opinion leaders (KOL), as well as regulatory officials. The ideal candidate should have experience in solid and hematologic tumor oncology, with experience in the design and conduct of clinical studies in this therapeutic area. Experience with cellular therapies is desirable. This is a full-time exempt position located at our corporate headquarters in San Diego, CA.Responsibilities
Provide clinical leadership of one or more programs across solid and hematological tumors.
Design competitive clinical strategies and deliver effective and timely study protocols in collaboration with clinical investigators, key opinion leaders and regulatory agencies to meet Fate scientific and corporate objectives.
Prepare study protocols, amendments, specific sections of study manuals, Investigator Meeting notebooks, and other documents with appropriate guidance and supervision.
Contribute to start-up activities, including the design and development of CRFs, Data Management Manuals, and Data Analysis Plans.
Address questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs.
Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities.
Assist in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
Play a leading role in the development and implementation of communications strategies to support existing and concluded studies.
May enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
Consistently comply with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines.
Maintain effective working relationships with team members to ensure scientific integrity of clinical studies.
May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Qualifications
MD degree with 5+ years of relevant scientific and/or drug development experience.
2+ years in clinical research in a pharmaceutical company, contract research organization, or academic institution is preferred.
Experience in oncology is required.
Demonstrated ability to be flexible and adaptable to change.
Ability to form effective working relationships with internal and external parties including investigators, KOLs, Clinical Sites, etc.
Outstanding written communication skills.
Strong presentation skills; highly effective at summarizing and presenting the key considerations and decision-points.
Working conditions & physical requirements
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Travel may be required.
Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
The anticipated salary range for this role is $280,000 - $310,000 + 20% annual target bonus.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy NoticeTo learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit *************************
⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker's personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud:- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.- We will only ask for personal information when applying for a position via our Careers page or thereafter.- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at **************************** to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.
$280k-310k yearly Auto-Apply 34d ago
Senior Director/Director Business Development (oncology)
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by
Overcoming Resistance In Cancer.
ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
The Director/Senior Director, Business Development, is a strategic leader responsible for driving growth, forging key partnerships, and advancing the company's oncology pipeline. This broad role requires experience in oncology drug development, strong scientific and commercial acumen, and the ability to influence at all levels both internally and externally. The Director/Senior Director, Business Development, will report directly to ORIC's Chief Business Officer and be involved in all aspects of business development, including competitive intelligence, alliance management, search and evaluation, in-licensing, out-licensing, and commercial assessments. The Director/Senior Director, Business Development, is expected to work collaboratively across functions within the organization, represent ORIC to external partners, and play a pivotal role in executing our corporate strategy and mission in oncology.
Job Description
• Develop and maintain a comprehensive understanding of the company's oncology pipeline, R&D capabilities, and strategic objectives.
• Lead competitive intelligence and therapeutic area landscape assessments in prostate cancer and non-small cell lung cancer, providing actionable insights to cross-functional stakeholders.
• Build and manage strategic alliances with current and prospective partners in the oncology space, ensuring alignment with corporate goals.
• Stay abreast of industry trends and competitor activities in oncology to inform business development strategy.
• Support executive leadership in strategic planning, forecasting, and the development of presentation materials for internal and external audiences.
• Identify, evaluate, and recommend new business development opportunities, including in-licensing, out-licensing, partnerships, and M&A, with a focus on oncology assets.
• Oversee due diligence processes, including scientific, clinical, market, and financial analyses to support business cases for new oncology opportunities.
Qualifications
• Bachelor's degree in life sciences required; advanced degree (MBA, MS, MD, or PhD) preferred.
• 8-10+ years of biotechnology or pharmaceutical industry experience, with a proven track record in oncology business development, competitive intelligence, market research, and/or strategic partnerships.
• Excellent communication, presentation, and relationship-building abilities.
• Strong analytical, financial modeling, and project management skills.
Key Competencies
• Commercial, clinical and scientific acumen in oncology
• Strategic thinking and problem-solving in oncology drug development
• Influencing and negotiation with scientific, clinical and commercial partners
• Cross-functional collaboration (R&D, clinical, regulatory, commercial)
Oncology-Specific Focus Areas
• Deep understanding of oncology therapeutic landscapes. Experience with prostate cancer and/or non-small cell lung cancer desired.
• Experience with interpreting scientific data, analyzing clinical trial designs, understanding regulatory frameworks, and evaluating commercial opportunities for oncology therapies.
• Ability to assess and communicate the value proposition of oncology programs to internal and external stakeholders.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $250,000-$285,000 for the Senior Director and between $210,000-$260,000 for the Director. The final salary offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$250k-285k yearly 7d ago
Vice President, Medical Affairs
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by
Overcoming Resistance In Cancer.
ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
ORIC is seeking a Vice President, Medical Affairs, as an initial member of the Global Medical Affairs (GMA) team based in the South San Francisco office. Reporting to the SVP of Medical Affairs and Commercial, this senior leader will be responsible for developing and executing the US and global GMA strategy and tactical plans with a focus on launch readiness and life cycle management for therapies across prostate cancer, non-small cell lung cancer (NSCLC), and potentially other tumor types. The VP will build and scale a high-performing GMA team while focusing on effectively analyzing and communicating key scientific data through publications, medical information, medical communications, and congress activities. The candidate must work collaboratively with cross-functional counterparts in Clinical Development and Operations, Regulatory, Research, Finance, Legal, and Commercial as well as other ORIC functional groups to design and implement a medical strategy for rinzimetostat in prostate cancer and enozertinib in NSCLC.
The ideal candidate will have pre- and post-launch experience in biotech/biopharma, is an experienced and collaborative leader, highly effective communicator, entrepreneurial, solutions-oriented, proactive, and scientifically driven.
Job Description
Key Responsibilities:
Build and lead the Global Medical Affairs (GMA) strategy and core capabilities in areas such as medical communications, operations, field medical, and a robust independent scientific research assessment process for all oncology assets.
Align medical strategy with corporate objectives, clinical development, regulatory, and commercial imperatives.
Build, mentor, and manage a high-performing Medical Affairs team, including Field Medical Science Liaisons (MSLs), Medical Information, Publications, and Evidence Generation.
Develop and execute the multi-year US and global medical strategy and plan for rinzimetostat and enozertinib, including activities related to scientific engagement and communication, internal education, and patient advocacy.
Work closely with the Clinical, Operations, CRO, and future MSL teams to provide recruitment, scientific, and engagement support to facilitate trial enrolment and conduct.
Drive Key Opinion Leader (KOL) engagement, advisory boards, and relationships with academic institutions, patient advocacy groups, and medical societies.
Lead integrated evidence planning, including clinical trial support, real-world evidence, and investigator-initiated studies.
Partner with Clinical Development, Regulatory Affairs, Market Access, and Commercial teams to ensure alignment of medical and business objectives.
Ensure all Medical Affairs activities comply with legal, regulatory, and corporate standards.
Manage operating budget, systems, processes, and future personnel efficiently to maximize ORIC resources.
Qualifications
An advanced medical/scientific degree: MD (preferred), PhD, or PharmD with a strong background in oncology.
Minimum 12-15+ years of experience in medical affairs, biotech and/or pharmaceutical industry with at least 5 years in a senior leadership role.
Must have a strong scientific background in oncology with deep understanding of biomarker-driven disease and ability to effectively analyze, synthesize, and communicate complex scientific information.
Proven leadership experience and track record in oncology product launches, lifecycle management, and building Medical Affairs capabilities.
Demonstrated ability to lead scientific engagement strategies and evidence generation programs and have familiarity with HEOR, expanded access programs, and global launch planning.
Strong networking skills with deep existing relationships and network with oncology healthcare professionals including global key opinion leaders.
Exceptional verbal, written, and presentation skills with the ability to effectively communicate complex scientific data to diverse audiences.
Ability to manage multiple priorities at one time with little direction and drive results in a fast-paced and dynamic environment.
Ability to thrive in a public, clinical-stage biotech environment with rapid growth and evolving priorities.
Ability to travel to South San Francisco and San Diego headquarters and to attend scientific congresses, trial related meetings, and key stakeholder meetings (domestic and some international) - up to 50% travel.
Manage and adhere to ORIC policies, ensuring compliance with corporate rules and government regulations.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $340,000-$380,000. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, degree type (MD vs. non-MD), title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$340k-380k yearly 25d ago
Senior Director/ Director, CMC Regulatory Affairs
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC's clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.
Job Description
Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC's products.
Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
Qualifications
BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
Experience in addressing CMC-related regulatory queries from global health authorities.
Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
Demonstrated success driving drug product development and managing all aspects of CMC documentation.
Excellent working knowledge and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
Excellent attention to detail, and strong computer and organizational skills required.
Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
Must have a quality mindset and deliver results in an ethical and positive manner.
Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
Proven ability to manage multiple tasks and associated deadlines.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 for the Director level and $250,000-$300,000 for Senior Director, level candidates . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
$250k-300k yearly 6d ago
Senior Director/ Director, CMC Regulatory Affairs
ORIC Pharmaceuticals 4.5
ORIC Pharmaceuticals job in South San Francisco, CA
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn.
Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC's clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.
Job Description
Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC's products.
Provide CMC regulatory support for new and ongoing clinical trials, e.g., manage/prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.
Lead preparation and responses for CMC-related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives.
Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans.
Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs , etc.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).
Qualifications
BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience.
At least 10+ years of highly relevant pharmaceutical/biotechnology experience with strong CMC background. Candidates at the Director level would be expected to have significant years of additional experience.
Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
Experience in addressing CMC-related regulatory queries from global health authorities.
Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
Demonstrated success driving drug product development and managing all aspects of CMC documentation.
Excellent working knowledge and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including FDA, EMA, ICH, WHO, USP-NF.
Prior experience as primary author of CMC sections of M2 and M3 of IND,NDA, and IMPD.
Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
Excellent attention to detail, and strong computer and organizational skills required.
Must be a strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
Must have a quality mindset and deliver results in an ethical and positive manner.
Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
Proven ability to manage multiple tasks and associated deadlines.
Additional Information
The anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 for the Director level and $250,000-$300,000 for Senior Director, level candidates . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
Zippia gives an in-depth look into the details of ORIC Pharmaceuticals, including salaries, political affiliations, employee data, and more, in order to inform job seekers about ORIC Pharmaceuticals. The employee data is based on information from people who have self-reported their past or current employments at ORIC Pharmaceuticals. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by ORIC Pharmaceuticals. The data presented on this page does not represent the view of ORIC Pharmaceuticals and its employees or that of Zippia.
ORIC Pharmaceuticals may also be known as or be related to ORIC PHARMACEUTICALS, INC., ORIC Pharmaceuticals, ORIC Pharmaceuticals Inc, ORIC Pharmaceuticals, Inc. and Oric Pharmaceuticals, Inc.