Jobs · Analyst · North Carolina

VP Clinical Development & Translational Science

Grifols · North Carolina, United States · 2 wk ago
AnalystFull-time

Role Overview

Vice President, Clinical Development & Translational Science
Location: United States (RTP, office-based, hybrid)
Reports to: Senior Vice President, Medical Development & Evidence Generation

Key Accountabilities

  • Strategic & Scientific Leadership
    • Define, own, and execute end-to-end clinical and translational development strategies across all development phases.
    • Provide senior scientific and clinical leadership to development teams and executive management, serving as a trusted advisor on program risk, opportunity, and strategic trade-offs.
    • Shape portfolio strategy through rigorous clinical/translational insight, mechanistic understanding, and dose/exposure-response frameworks.
    • Lead due diligence for new indications, assets, and patient solutions, contributing clinical and translational expertise to business development decisions.
  • Clinical Development Excellence
    • Oversee the design and execution of global clinical development plans, protocols, and trials, including first-in-human studies and large, randomized, multi-regional trials.
    • Ensure clinical programs are scientifically sound, operationally executable, and aligned with regulatory and patient expectations.
    • Interpret and integrate clinical data to guide development decisions and support global regulatory submissions (INDs, BLAs/NDAs).
    • Lead clinical advisory boards, investigator meetings, and external scientific engagements.
  • Translational Science & Pharmacology
    • Provide strategic oversight of Translational Medicine, Pharmacology, and Preclinical Sciences, ensuring compelling biological rationale and continuity from bench to bedside.
    • Drive development and validation of bioanalytical assays, biomarkers, and PK/PD strategies to support safety, efficacy, and dose selection.
    • Ensure readiness of non-clinical and translational packages to enable efficient IND filings and accelerated development where appropriate.
  • Regulatory & External Engagement
    • Serve as a senior clinical representative with FDA, EMA, and global health authorities, supporting pre-IND, scientific advice, BLAs and regulatory negotiations.
    • Approve and contribute to key regulatory and scientific documents, including briefing books, study reports, investigator brochures, and white papers.
    • Represent Grifols externally as a scientific thought leader in industry forums, advisory boards, and key stakeholder meetings.
  • Organizational Leadership & Capability Building
    • Lead and develop a globally distributed team of Clinical Physicians, Clinical Scientists, Translational Scientists, Pharmacologists, and Medical Writers.
    • Establish best-in-class standards, governance, and processes across Clinical Development, Translational Science, and Medical Writing.
    • Ensure excellence in GCP, GLP, ICH, and regulatory compliance, embedding quality and accountability across all activities.
    • Build scalable, future-ready capabilities that support pipeline growth, innovation, and accelerated development pathways.
  • Cross-Functional Collaboration
    • Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Medical Affairs, Commercial, Health Economics, Legal, Finance, Global Program Teams, Project Management and external experts.
    • Foster a collaborative, matrix-based culture that promotes transparency, scientific rigor, and shared ownership of outcomes.
    • Provide clinical insight into portfolio prioritization, resourcing decisions, and long-range planning.

Education

  • MD, MD/PhD, PhD, PharmD, or equivalent advanced scientific/medical degree.

Experience

  • Typically 12+ years in pharmaceutical or biotechnology development in North America and/or Europe.
  • Ideally with extensive experience in plasma therapeutics.
  • Strong insight into clinical development strategy of non-plasma therapies, such as recombinant proteins.
  • Proven leadership in clinical development, with hands-on experience across trial design, execution, interpretation, and regulatory submissions.
  • Demonstrated experience working directly with global health authorities (FDA, EMA).
  • Track record of leading and mentoring multidisciplinary, global teams in a matrix environment.
  • Experience across multiple therapeutic areas and development modalities strongly preferred.

Leadership & Personal Attributes

  • Credible scientific leader with executive presence and strategic mindset.
  • Collaborative, inclusive leader who inspires teams and encourages innovation.
  • Comfortable navigating complexity, ambiguity, and change.
  • Strong communicator with the ability to influence at senior and executive levels.
  • Hands-on, pragmatic, and outcomes-driven, aligned with Grifols’ culture and values.

Third Party Agency and Recruiter Notice

Agencies that present a candidate to Grifols must have an active, non-expired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Equal Employment Opportunity

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Similar jobs

VP, Clinical Science

Telix Pharmaceuticals LimitedUnited States· 3 wk ago
RemoteHealthcareapply on telixpharma.com