Clinical Research Manager
2 weeks ago
Astellas Pharma Inc. is seeking a highly skilled Clinical Scientist to join our team. As a Clinical Scientist, you will be responsible for leading the development and execution of clinical trials, providing expertise to cross-functional teams, and serving as a key partner for Development Division.
Key Responsibilities- Lead Clinical Trials: Develop and execute clinical trial protocols, investigator brochures, CRFs, informed consents, and clinical study reports.
- Provide Expertise: Synthesize and contextualize data to facilitate discussion and timely decision making with cross-functional teams.
- Support Clinical Development Plans: Prepare clinical development plans, site identification and management, and DESC meetings.
- Medical Monitoring: Review, analyze, and triage patient data, generating reports under the guidance of study physician/med lead.
- Lead Working Groups: Independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
- Prepare for Health Authority Meetings: Partner with GML in preparing for Health Authority (HA) Meetings and assist in addressing HA inquiries.
- Support Regulatory Submissions: Together with the GML and Product Responsible Person, prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
- Train Clinical Trial Staff: Provide training at investigator meetings and site initiation visits with clinical trial staff.
- Collaborate Cross-Functionally: Collaborate cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
- Support Engagement with Sites: Support engagement with potential and current sites, including SIVs, investigator meetings, conferences, steering committee, advisory board meetings.
- Exhibit Expertise in Study Data Review and Analysis: Provide clinical input into statistical planning, data analysis, and interpretation, and lead the publication of data (manuscripts, presentations) and disease or technology-related scientific publications.
- Work with Operations Group: Work closely with operations group for site and vendor feasibility, trial set up, and monitoring.
- Lead Contract Execution: May lead the execution of contracts, particularly for investigator meetings and advisories.
- Support Strategic Partnerships: Support efforts to develop strategic partnerships with Key External Experts (KEEs).
- Assess Candidates: Serve as a key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies.
- Represent Development: May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
- Support Strategic Initiatives: Support strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
- Advanced Degree: Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-10 years clinical, scientific/research, pathology or industry-related experience or combination of academia and industry.
- Thorough Knowledge: Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early stage development through approval) from initial study design, study execution, and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
- Scientific Research and/or Clinical Practice: Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications, and/or relevant accreditations).
- Computer Skills: Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams, and MS Project) and in the use of industry-standard software (e.g., electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.).
- Collaboration and Interpersonal Communication: Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science, and Pharmacovigilance (PV).
- Key External Stakeholders: Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
- Global Pharmacovigilance Standards: Knowledge of global pharmacovigilance standards and guidance documents.
- Flexibility and Adaptability: Comfortable working in a flexible, dynamically changing, and (at times) challenging environment.
- Strategic Planning and Organizational Skills: Excellent strategic planning, organizational, and verbal and written communication skills.
- Sound Judgment and Diplomacy: Ability to exercise sound judgment, tact, diplomacy, and professionalism in all interactions. Highest level of scientific integrity.
- Independence and Attention to Detail: Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
- Travel Requirements: Able to travel ~25%, with international travel at times.
- Degree: D. or PharmD degree, or other relevant Master's degree.
- Medical Affairs Activities: Knowledge and proficiency related to Medical Affairs activities including registries.
- Medical, Dental, and Vision Insurance
- Generous Paid Time Off
- Country Specific Retirement Savings Plan
- Company Paid Life Insurance
- Annual Corporate Bonus and Quarterly Sales Incentive
- Long Term Incentive Plan
- Referral Bonus Program
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