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    Senior Director, Clinical Research- Specialty In Pulmonary Diseases – Md Required

    Pfizer
    5+ years
    $266,500 - $444,100
    Cambridge Massachusetts United States
    10 Jan. 24, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Senior Director, Clinical Research – Specialty in Pulmonary Diseases

    Location: Cambridge, Massachusetts, United States
    Job Type: Full-Time
    Job ID: 4922270
    Posted: 2 Days Ago

    Purpose of the Role

    The Senior Director of Clinical Research will lead the development of first-in-man (FIH), proof of mechanism (PoM), proof of clinical activity (SoCA), and proof of concept (PoC) studies for novel biological and small molecule therapies in the field of respiratory diseases. This role involves managing phase 2 studies and collaborating with the Pfizer development operations and project teams to ensure the timely delivery of clinical studies.

    Key Responsibilities

    Clinical Trial Design & Implementation

    • Lead the design of PoM, SoCA, and PoC trials in consultation with Key Opinion Leaders (KOLs) and the Pfizer project team, including statisticians, clinical pharmacologists, and regulatory experts.
    • Develop primary and secondary endpoints for efficacy and safety, and contribute to precision medicine and biomarker strategy.
    • Ensure that clinical development strategies are being implemented effectively and contribute to key milestones such as trial start-up and delivery.

    Safety Oversight

    • Monitor safety across studies, including the review of serious adverse events, and respond to safety concerns.

    Leadership and Collaboration

    • Provide leadership in preparing critical documents such as clinical protocols, clinical development plans, investigator brochures, and regulatory documents.
    • Foster collaboration between the clinical team and other departments like the Inflammation and Immunology Research Unit (I&I RU), clinical pharmacology, and biostatistics teams, ensuring successful transitions between project phases.

    Trial Execution & Recruitment

    • Manage and recruit investigators and ensure proper site management.
    • Coordinate and maintain relationships with external experts, consultants, and investigator networks.

    Strategic Contributions

    • Participate in strategic assessments of the Inflammation and Immunology Research Unit (I&I RU) portfolio and contribute to business development activities.
    • Collaborate with late-stage development colleagues to analyze POC clinical data and develop Phase 3 strategies.

    Knowledge Sharing & Industry Awareness

    • Stay updated on relevant scientific and clinical literature, including key clinical development issues.
    • Cultivate relationships with key stakeholders, such as external experts and regulatory bodies.

    Qualifications

    Education

    • Requires an MD or MD/PhD with a specialty in Pulmonary Diseases. Other specialists with experience in respiratory clinical trials will also be considered.

    Experience

    • At least five years of experience in biopharmaceutical clinical research, with a minimum of two years in the respiratory field.
    • Experience as a medical monitor and clinical lead across therapeutic areas is desirable.
    • Familiarity with biostatistics, regulatory affairs, clinical pharmacology, pre-clinical toxicology, pharmacogenomics, and biomarker-based approaches.
    • Proven ability to analyze and interpret complex datasets and work in a matrixed team environment.

    Skills

    • Strong scientific productivity (publications, abstracts).
    • Excellent communication, presentation, and scientific writing skills.
    • Demonstrated leadership in driving innovation and meeting project goals.

    Compensation and Benefits

    • Base Salary: $266,500 - $444,100 (based on experience).
    • Bonus: Eligible for a 25% target bonus based on performance.
    • Additional Benefits:
      • Pfizer Global Performance Plan.
      • Comprehensive benefits including 401(k) matching, paid leave, health coverage, and more.
      • Relocation assistance may be available.

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity employment and complies with applicable laws governing nondiscrimination in employment. This role requires permanent work authorization in the U.S. Pfizer is an E-Verify employer.

    Join Pfizer and lead the way in advancing respiratory disease treatments!

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    Melbourne | Remote - Europe | Victoria | Springville | Remote | Hungary | Zaragoza | Lousiana | Castlebar | Minnesota | Green Way | Remote - South America (Latin Americal) | Faridabad | Thailand | Belgium | Bountiful | Leinster | Texas | French | McFarland | Manipal | Remote - Africa | Slovakia | Hammond | Ireland | Remote, USA | Nairobi | Medan | Riga | Lenexa | Tulsa | Switzerland | Blue Bell | Remote - Middle East | Xzagreb | Bishop |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | King Abdullah Economic City | Khulais | Najran | Rabigh | Jeddah |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |