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Mallinckrodt Pharmaceuticals · 4 hours ago

Senior Director, Clinical Development

Philadelphia, PA

Full-time

Hybrid

Director/Executive

$285K/yr - $315K/yr

8+ years exp

Mallinckrodt Pharmaceuticals is seeking a Senior Director of Clinical Development who will provide expert clinical advice across all phases of clinical research. The role involves oversight of clinical development execution, leading multiple clinical study programs, and serving as the primary contact between internal teams and external stakeholders.

Biotechnology

Responsibilities

Acts as the lead clinical representative on Project Teams

Act as the key contributor in development of clinical development strategy across multiple indications

Develop, review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents

Oversee safety monitoring of ongoing clinical studies under their leadership with appropriate support as needed

Interact and lead engagements with thought leaders within the respective therapeutic area/indication

Track with Program Management the CD deliverables across all clinical studies/projects

Lead identifying, contracting and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc

Oversee regular maintenance and update of the CD project folders/drives

Reviews the informed consent form (ICF); ensures alignment with the related safety sections of the study protocol

Develops, reviews and/or approves clinical and safety and monitoring CRF pages

Act as the key contributor in development of clinical development strategy across multiple indications

Collaborates in study team meetings, data monitoring committee and steering committees as necessary

Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio

Review, guide and finalize study documents such as Protocol Synopses, Protocols, Protocol amendments, Administrative Change letters etc

Ensure CD contributions to trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the safety management plan, the medical monitoring plan, Clinical Study Report (CSR) etc

Ensure regular and ad-hoc data reviews and interpretation; preparation of summaries/documentations of these reviews to Leadership

Ensure timely development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal and external documents and communications as needed

Work collaboratively with the clinical study team and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (CSRs, IBs, IND sections, CTAs, ISS and ISE sections and clinical expert reports)

In collaboration with the Development Operations staff, develops the operational strategies for clinical research studies and development programs including, but not limited to, PI selection, CRO selection, budgets, and timelines

Ensure CD participation in vendor selection, specification development, and management/oversight, as needed

Ensure development of study specific training materials for study team, investigational sites, and vendors

Participate and present at Investigator meetings or similar

Lead the responses to scientific and data-related queries

Collaborate with statistician in data review and interpretations

Act as the primary medical monitor with support as required to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends

Develop and/or review narratives for AEs/SAEs/AESIs as necessary

Collaborate with the statistician to identify any trial-related efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends

Qualification

Board licensed MDClinical Development experienceImmunology expertiseClinical protocol designMedical/Scientific writingData analysisProject managementMicrosoft Office SuiteCross-functional collaborationCommunication skillsOrganizational skillsPresentation skills

Required

Board licensed MD (or equivalent foreign qualification) in Immunology

Minimum of 8-10 years of Clinical Development experience (pharma, CRO) in Immunology/Autoimmunity

Previous experience designing and developing phase 1-4 protocols

Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.)

Experience working on a matrix cross-functional clinical team

Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record

Solid Medical/Scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents

Working knowledge of statistics, data analysis and data interpretation

Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB's and GCP/ICH are necessary

Excellent written and oral communication skills

Organizational and cross functional collaboration skills

Proficient in Microsoft Office Suite of Programs

Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs, integrating clinical science, disease area knowledge, and operational requirements

Incumbent must be able to work with colleagues at all levels of responsibility and authority

Ability to work on multiple projects with aggressive timelines

Action oriented, flexible, able to adapt to changes in priorities, projects, and daily activities

Strong presentation skills

Strong MSP skills

Up to 20% travel