Associate Director, Global Clinical Scientist

CSL Plasma•Waltham, PA

21h•Hybrid

About The Position

The Associate Director, Global Clinical Scientist is a leadership role in the Clinical Development group supporting the Hematology Therapeutic Area. This multifunctional clinical project position may be delegated aspects of Clinical Development Team (CDT) leadership depending on program needs. The role works closely with other Clinical Representatives on delegated tasks supporting clinical development programs, including approximately 30–40% external innovation assessment, Search & Evaluation support, and due diligence, depending on program needs and status. The role provides scientific leadership across clinical programs and studies, helping ensure alignment with the clinical development plan, patient safety, data integrity, scientific quality, and regulatory compliance. It collaborates with internal and external cross-functional stakeholders, supports clinical strategy and regulatory activities, and contributes to scientific analyses, reports, presentations, publications, and regulatory submissions. This is a hybrid position requiring at least three onsite days per week. The listed base salary range for the Waltham, Massachusetts work location is $188,000–$222,000 per year. Total compensation may also include incentive compensation and equity. Relocation assistance and visa sponsorship are not provided.

Requirements

Bachelor’s degree or equivalent in a science-related field.
At least 8 years of clinical research experience in one or more Clinical Development functions within the biotechnology or pharmaceutical industry.
Demonstrated experience in clinical development strategy, protocol design, clinical study execution, data interpretation, and scientific document authorship.
Advanced ability and experience working across multiple studies to incorporate consistent medical and scientific concepts into multiple protocols and ensure alignment with strategic program objectives.
In-depth understanding of the drug development process.
Demonstrated experience in regulatory interactions, including preparation of submissions such as IND, NDA/BLA, MAA, and PIP, protocols, and briefing books, and responses to health authority questions across meeting types and agencies.
Hybrid work arrangement requiring at least three onsite days each week.

Nice To Haves

An advanced science degree (MSc or PhD), PMP certification, or equivalent.
Experience evaluating external opportunities, conducting scientific due diligence, supporting portfolio assessments, or contributing to business development activities.
Experience providing oversight to contract research organizations (CROs).
Clinical development experience leading a matrix team or complex clinical program, with working knowledge of pharmaceutical and regulatory development processes.
Formal leadership or management training, including matrix team management.

Responsibilities

Provide scientific leadership in developing clinical programs, ensuring scientific consistency and alignment with the clinical development plan in Hematology.
Provide scientific and clinical development input to support safe, efficient, timely execution of assigned clinical studies and ensure high-quality, compliant outputs.
Author or contribute to clinical studies and study-level documents and training materials aligned with scientific strategy, including protocols, eCRFs, informed consent forms, study reference manuals, and investigator training.
Collaborate with internal and external cross-functional stakeholders to translate clinical strategy and study protocols into operational deliverables.
Define and implement medical monitoring and oversight strategies for individual clinical studies, including ongoing review of blinded data, to support patient safety and data integrity.
Manage processes and liaisons supporting external study oversight committees, such as steering committees, independent data monitoring committees, and adjudication committees.
Contribute to scientific analysis and interpretation of clinical study data and to clinical study reports, scientific meeting presentations, peer-reviewed publications, and regulatory submission documents.
Support the Global Clinical Program Lead (GCPL) with program-level responsibilities, including regulatory interactions, clinical strategy, the Clinical Development Plan, and development or updating of the Investigator’s Brochure.
Contribute to multidisciplinary working groups supporting continuous process improvement as requested.
Support external innovation assessment, Search & Evaluation, and due diligence activities as program needs and status require.