We are looking for people from diverse backgrounds who share our passion for science and drive to advance liver disease and immune modulating therapies. Apply today via email@example.com.
Summary of Position:
This position leads the Quality program through day-to-day management of functions to support product development, manufacture, testing, and release of clinical trial and nonclinical materials in accordance with regulatory requirements and quality standards. Responsible for the short and long-term goals of quality assurance (QA) in support of IND, NOA, and commercial products and other milestones.
This position is required to work with both internal and external parties to provide direction on compliant operational practices.
This position will provide review of production and testing raw data/ reports, work with various groups/ vendors to oversee investigations, design/ utilize quality systems, and compile/ present quality metrics.
This position is responsible for reports on progress of company Quality systems and strategies and participates in reviewing regulatory submissions. May occasionally travel nationally/internationally and represent the company during audits and technical visits.
- Oversee all departmental functions including audits and record reviews to support product release, non-clinical and clinical data reporting.
- Provide quality oversight to vendors and internal laboratories. Monitor adherence to company policies and procedures.
- Drive product quality improvements, evaluate product batches, coordinate investigations/CAPA, and compile metric evaluations.
- Manage contracted QC activities.
- Manage the document management system and legacy documents, including electronic signatures.
- Train quality employees, and author/revise corporate quality SOPs, and ensure ongoing compliance.
- Present training sessions, quality concerns/updates internally and to clients.
- Prepare and formally present Quality strategy internally and externally.
- Assure the quality of regulatory submissions, including protocols, investigational brochures, and IND amendments.
Job Requirements (essential knowledge, skills and attributes):
- Bachelor’s degree or greater in science, pharmacy or engineering required, Master’s degree preferred.
- Seven to twelve years of compliance related experience with regulated activities.
- Compliance experience at a biotechnology/pharmaceutical organization.
- Demonstrated supervisory experience.
- Working knowledge of GMP regulations necessary.
- Working knowledge of GLP and GCP regulations preferred.
- Experience with vendor auditing/management, and investigations.
- Skills in regulatory inspection/management, project management and general organizational skills.
- Strong interpersonal skills (e.g., listening, writing, facilitation, presentation).
- Ability to work in a collaborative environment.
Summary of Position:
The Senior Director, Vice President, Regulatory Affairs will lead development of regulatory strategy, build processes to ensure global regulatory compliance, and manage all regulatory submissions and interactions. The Director will prepare for meetings, teleconferences, and other communications with FDA and other regulatory agencies, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
- Lead the development of global regulatory strategy, ensuring that programs meet quality and safety standards required by patients, health care providers, and regulatory agencies.
- Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
- Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.
- Provide critical review of all documentation supporting regulatory applications, including organization of regulatory file rooms and document signatures.
- Lead the preparation and submission of regulatory submissions to FDA and other regulatory agencies.
- Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
- Monitor applicable current and new regulatory requirements.
- Review and update regulatory processes and documentation practices to ensure company is in compliance and audit ready.
- Interact with company partners and consultants on regulatory matters.
- Contribute to the regulatory perspective on government proposals and external due diligence activities.
Job Requirements (Essential knowledge, skills and attributes):
- Advanced Degree (M.S. or Ph.D. preferred) in a Biological Science or Doctor of Pharmacy (Pharm.D,).
- Minimum of 7 years of regulatory affairs biologics industry experience required, vaccine or peptide experience preferred but not required.
- Direct interaction experience with FDA required.
- Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.
- Experience with submissions via eCTD (electronic gateway).
- Excellent writing skills are required.
- Excellent leadership, interpersonal, written and oral communication skills.
Summary of Position:
To address Altimmune’s increasing clinical needs, the Company is seeking a Director, Clinical Development to drive the clinical research strategy across the portfolio of vaccine and drug candidates. The Director, Clinical Development will report to the CMO and will oversee the clinical development of Altimmune’s pipeline. S/he will be expected to ensure that all programs meet quality and safety standards required by the medical community and regulatory agencies. The Director, Clinical Development will be able to operate both at a high strategic level and execute at a tactical level with ease. The Director, Clinical Development will also play important roles in business development activities.
Summary of Essential Duties:
- Assist in the development of Altimunne’s clinical research strategy for product candidates across preclinical development, clinical research, manufacturing and regulatory affairs.
- Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
- Develop clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials.
- Oversee management of clinical trials including investigator selection, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection and analysis.
- Identify suitable clinical trial sites and develop effective working relationships with clinical investigators and thought leaders.
- Oversee safety, including the review of SAEs and safety data; ensure that sites and regulatory agencies are notified and all company and regulatory procedures are compliant.
- Manage CRO’s; including identifying suitable partners, defining CRO responsibilities, communication plan, divisions of responsibility, milestones, contracts, reviewing monthly status reports, and maintaining interactive management to ensure project success.
- Oversee regulatory filings, including drafting, editing and preparing of routine correspondence and sections of INDs, BLAs, NDA’s, Annual Reports, Amendments, Supplements, Orphan Drug Applications and other regulatory submissions.
- Oversee development and maintenance of clinical SOPs related to GCP activities.
- Ensures that all Altimmune’s drug and vaccine clinical programs are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines and all applicable regulatory requirements.
- Provide expert opinion and due diligence research on business development opportunities.
- Represent Altimmune’s clinical and medical strategy to internal and external stakeholders including the Board of Directors and investors
Summary of required/desired knowledge, skills, and other abilities or attributes:
For this role you will need
- Medical degree/MD
- Minimum five (5) years in either clinical practice or relevant setting, clinical research experience
- Minimum one (3) year in pharmaceutical industry (clinical research, pharmacovigilance, or Medical Affairs) or equivalent
- Knowledgeable in medicine and pharmaceutical product safety
- Experience applying medical knowledge to the interpretation of individual case review