Position:          Senior Manager to Associate Director, Bioanalytical and Biomarker Sciences Department: Translational Science Location:         Remote with occasional onsite meetings, up to 20% travel Reports To:    Director, Translational Science – Clinical Pharmacology            Position Summary This Bioanalytical and Biomarker (BABM) position will lead and contribute to the BABM strategy to support assigned project progression from IND application to clinical development to BLA submission.  This position will manage BABM CROs to ensure clinical BABM assay development and sample analysis meet project timelines.  The ideal candidate will have in-depth BABM knowledge, strong strategic thinking, excellent verbal and written communication skills.   Responsibilities <ul> <li>Serve as BABM expert on cross-functional drug development teams and lead BABM related program(s) and activities.</li> <li>Lead internal process and procedure setup and develop corresponding SOPs.</li> <li>Lead and manage BABM data interpretation, and reporting; present bioanalytical results and update BA status to study teams.</li> <li>Interface with internal study and clinical teams to define and execute BABM strategies.</li> <li>Write and review relevant sections of study protocols, analysis plans (assay development and validation plans, sample analysis plan), reports (validation report, sample analysis report), Investigator Brochures, documents for IND filings and NDA/BLA submissions, ensuring that designs and documents meet regulatory and compliance requirements and project timelines.</li> <li>Select and manage BABM CROs conducting regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker sample analysis.</li> <li>Monitor BABM CROs process and procedures to ensure their work qualities.</li> </ul>   Qualifications <ul> <li>Doctors or Masters degree in chemistry, biology, biochemistry, or related discipline with an emphasis on analytical techniques with 8+ years of industry work experience in BABM areas.        </li> <li>Expertise and knowledge of laboratory procedures, practices, and applicable SOPs.</li> <li>Strong working knowledge of regulations, guidelines, standards that guide collection and utilization of non-clinical and clinical samples and data.</li> <li>Familiarity with regulatory expectations (FDA and EMA) and industrys best practices in BABM method development and validation.</li> <li>Ability to diagnose and solve complex technical and scientific problems. </li> <li>Excellent communication skills and organization skills.</li> </ul> Salary: $130,000 - $180,000 About Angitia Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the teams extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.  Learn more at <a href="http://www.angitiabio.com/">www.angitiabio.com</a> Benefits: <ul> <li>Medical, dental, and vision coverage for employees and their eligible dependents</li> <li>401(K) Retirement Plan with partial Company match</li> <li>Company paid Long Term Disability Coverage</li> <li>Company-paid life Insurance &amp; AD&amp;D Coverage</li> <li>Voluntary Life Insurance &amp; AD&amp;D Coverage</li> <li>Employee Assistance Program (EAP)</li> <li>Company-paid Holidays</li> <li>Vacation</li> <li>Paid Sick Leave</li> <li>Telecommunication Monthly Stipend</li> <li>Work-From-Home Equipment Reimbursement</li> </ul>