Senior Clinical Program Manager - Regulatory Submissions
Mindlance
A national recruiting company is seeking a skilled Project Manager to oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal candidates will possess strong leadership, project management skills, and extensive experience in the pharmaceutical industry. This position requires a Bachelor's degree and relevant experience, with opportunities for career advancement within the organization. #J-18808-Ljbffr Mindlance
$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco... ...Regulatory Affairs, REMS Program is responsible for leading... ..., including original REMS submissions, assessments,... ...Committees, inspections)* Manage all aspects of preparation...SeniorFor contractors$5,000 per month
...independent lives. Our comprehensive programs empower foster youth to... ....POSITION SUMMARY: The Clinical Manager is an energetic,... ...participant records including timely submission of all utilization,... ...policies and protocols and all regulatory requirements.Work with referral...SuggestedFull timeCasual workWork at officeLocal areaTrial periodVisa sponsorshipWork visaRelocation packageFlexible hoursAfternoon shift2 days per week3 days per week$165k - $180k
...Senior Technical Program Manager, Compliance Amperesand is reinventing how the world powers its most... ...at the intersection of engineering, regulatory requirements, quality, and... ...ensuring that testing, certification submissions, and regulatory approvals are sequenced...SeniorTemporary workLocal areaShift work$164k - $205k
Overview Revolution Medicines is a late-stage clinical oncology company developing novel... ...Professional. As a Sr. Clinical Program Manager, you will act as a central contact for... ...including authoring clinical study and regulatory documentation and SOPs. Experience in...SeniorFull timeContract workTemporary workWork at officeLocal area$165k - $195k
...leadership and support to global regulatory activities to achieve Alumis’... ...Lead preparation, review and submission of INDs/CTAs, amendments,... ...investigator document packages and manage other regulatory activities... ...CTAs, including nonclinical, clinical, and CMC activities, while...SeniorHourly payContract workWorldwide$164k - $205k
Revolution Medicines is a late-stage clinical oncology company developing... ...for the successful management of all aspects of clinical trials... ...timelines and designated program budgets. Partner with cross... ...clinical study and regulatory documentation and SOPs. Experience...SeniorFull timeContract workTemporary workWork at office$230k - $270k
Allogene Therapeutics is seeking a Senior Director to lead the Portfolio & Program Management Team in South San Francisco. This role involves managing a cross-functional team to drive execution of key programs in the biotech space. Required qualifications include a Bachelor...Senior$230k - $270k
...South San Francisco, is a clinical-stage biotechnology... ...autoimmune disease. Led by a management team with significant... ...a talented, motivated Senior Director to join our Portfolio & Program Management Team as a... ...from Research, Clinical, Regulatory, Ops Tech, and...SeniorLocal areaRemote work$220k - $270k
...Pharmaceuticals is a clinical stage... ...a Director, CMC Regulatory Affairs, to join... ...clinical development programs for oncology products... ...clinical trials, e.g., manage/prepare CMC... ...aspects of regulatory submissions, including... ...000-$300,000 for Senior Director, level candidates...SeniorCurrently hiring- Senior Director, Regulatory Affairs (Strategy, Hematology Oncology)... ...Nurix Therapeutics is a clinical stage... ...objectives, policies and programs pertaining to development... ...nonclinical and clinical submissions and interactions in... ...and life cycle management activities. This includes...SeniorFor contractors
- UCSF Health is looking for a Clinical Research Manager to lead administrative, clinical, and regulatory operations for the Memory and Aging Center. The role involves strategic collaboration with senior management to advance treatments for Alzheimer's Disease and related...Senior
$270k - $300k
Senior Director, Regulatory Affairs - Oncology Strategy Pliant Therapeutics is a clinical‑stage biopharmaceutical company and... ...Pliant’s oncology programs. This involves oversight... ...all interactions/submissions to global Health... ...product team in managing and directing regulatory...SeniorRemote jobFull timeTemporary work$218.06k - $327.09k
...Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs The Senior Director, Oncology Cell... ...GRL on complex programs with multiple indications... ...current stage through BLA submission. May serve in dual-... ...aspirations and update senior management on project risks/...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week$248k - $310k
...Senior Director, Regulatory Operations Kardigan is a heart health company working to make cardiovascular disease preventable... .... This role is responsible for end-to-end management of global regulatory submissions, ensuring timely and compliant publishing, electronic...SeniorFor contractors- ...San Francisco is seeking an experienced professional to oversee clinical data collection and validation. The ideal candidate will have... ...This role involves developing clinical databases and ensuring regulatory compliance while collaborating with cross-functional teams....Senior
- A biotechnology company is seeking a Senior Medical Director, Safety Sciences to provide... ...oversight across multiple development programs. The ideal candidate will have an MD... ...leading safety assessments, preparing regulatory submissions, and mentoring team members. A...Senior
- ...Senior Medical Director South San Francisco, California... ...(Onsite) Category: Clinical Sciences / R&D Our... ...architect for programs moving from preclinical... ...human clinical needs. Regulatory & Scientific Content:... ...CSRs), and regulatory submissions. Who You Are...Senior
$172k - $234k
...Senior Manager, Statistical Programming Kardigan is a heart health company working to... ...Programming Department: Clinical Data Sciences &... ...ADaM and TLF, for CSR and regulatory requests, publication needs... ...SDTM, ADaM) and regulatory submission requirements. Good...SeniorFor contractors$220.6k - $275.7k
...that includes mid- to late-stage programs in Alzheimer’s disease... ...average. Position Summary The Senior Director, Regulatory Operations provides strategic and... ...operations, overseeing electronic submissions, regulatory information management systems, and end‑to‑end submission...SeniorWork at officeLocal areaRemote workWorldwideNight shift3 days per week$374k
...: The Medical Director/Senior Medical Director at Calico will report to the Head of Clinical Sciences and will be responsible... ...areas to shape new clinical programs at multiple points in their... ..., Clinical Study reports, regulatory submissions and responses, and other...Senior$300k - $358k
...seeking an experienced Senior Medical Director in Clinical Development who will be... ...successfully advance clinical programs as well as the overall... ...Protocol Amendments and Regulatory Submissions. Provide oversight... ...rheumatology. Coach, manage, inspire, and support...SeniorRemote work$337.5k - $412.5k
...Senior Medical Director South San Francisco... ...to join our Clinical Sciences team and... ...clinical development programs for game-changing... ...review clinical-regulatory documents,... ...coordination with project management, CMC, nonclinical... ...preparation and submission of scientific...Senior$324k - $409k
...We are advancing a clinical-stage pipeline of... ...Position Summary: The Senior Medical Director... ...across portfolio programs, assisting in... ...participating in key regulatory interactions and... ...related activities: Manage interactions with... ...preparation and submission of clinical trial...SeniorContract work$315k - $388.33k
...patients. This job provides senior clinical leadership for safety... ...multiple development programs or a therapeutic area. Leads... ...and risk assessment and management activities across development... ...safety reports, regulatory safety submissions, and safety sections of regulatory...SeniorLocal area$259k - $312k
...vision we are seeking a Senior Director / Vice President of Clinical Operations who will... ...Technical Operations, Clinical, Regulatory, External R&D,... ...-Concept phase Asset Management: Serve as the Clinical Operations... ...FIH through NDA/BLA submission (must include Proof-of-Concept...SeniorWork at officeHome officeFlexible hours3 days per week$282k - $349k
...IDEAYA employees, managers, and leaders to... ...business partnerships. Submission of unsolicited... ...and improving clinical outcomes for patients... ...We are seeking a Senior Director of... ...customers; ensure programs and materials comply... ...Medical, Legal & Regulatory (MLR) reviews...SeniorContract workTemporary workWork at officeLocal areaWork from home- Lyell Immunopharma is seeking a Contract Program Manager II for its Clinical Development Operations team. The ideal candidate should have extensive experience in project management within the biotech industry, particularly in clinical development. The role involves developing...Contract work
$192k - $306k
...Senior / Principal Technical Program Manager, Life Sciences AI Cambridge, MA USA; San Francisco, CA USA Your Impact at LILA Lila is building... ...unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing...SeniorFull timeWork at officeLocal areaFlexible hours$179k - $221k
IDEAYA is seeking a Senior Clinical Data Manager based in South San Francisco, CA. The role involves leading data management processes for late phase clinical trials and requires 8+ years of experience in clinical data management. Candidates with experience in oncology...Senior$211k - $258.67k
...patients. The Director, Clinical Regulatory is a highly motivated... ...complex development programs, leading project... ...executing preparation, submission, and maintenance of... ...Recruiting, developing, managing, and mentoring... ...when interacting with senior management, health authorities...Temporary workWork experience placementLocal area
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