Job Description:

JOB DESCRIPTION

SUMMARY

The Senior Director, Clinical Development will have ownership over clinical development strategies, plans and leadership for execution of clinical development programs for all Generic and 505(b)(2) products for Mallinckrodt Specialty Generics (SpecGx). This individual will be responsible for providing guidance for optimizing formulation development strategies, designing and conducting bioequivalence (BE) or other clinical studies in line with FDA and/or global regulatory requirements, interpreting study results, and preparing clinical sections of regulatory submissions. This position will also be accountable for all nonclinical PK studies and toxicology deliverables supporting drug development projects. The Senior Director, Clinical Development will manage partnerships with contract research organizations (CROs), other vendors and testing sites involved in clinical studies and will serve as a functional leader, mentor, and line manager. This individual will be responsible for building and leading a team of professionals who oversee operational aspects of clinical trials.

This position is also a scientific and clinical liaison between internal teams and external groups such as vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, and Key Opinion Leaders.

This position is based in St. Louis, Missouri.

ESSENTIAL FUNCTIONS

* Drives and oversees the design, monitoring and interpretation of pharmacokinetic, clinical endpoint and in vitro bioequivalence studies for ANDA and 505b(2) NDA submissions.

* Accountable and responsible for the Clinical Pharmacology support for assigned projects, including ensuring valid methods are used in the bioanalysis of samples collected during studies and providing interpretation of clinical pharmacology data.

* Provides clinical assessments of candidates for pipeline evaluation and, for the selected products, oversees successful design, implementation and completion of clinical development strategies.

* Serves as key clinical research lead for products in development at strategic meetings / advisory boards.

* Serves as the clinical lead with investigators and regulatory authorities.

* Mentors and transfers knowledge across project teams.

* Develops, reviews, and approves any relevant bioequivalence (BE) or other clinical studies regulatory submission documents, including synopsis, protocol, statistical plans, study reports, and appendices.

* Responsible for summarizing and interpreting results of pharmacokinetic and pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.

* Manages the forecasting, planning, execution and reporting of clinical development programs.

* Responsible for oversight of service providers, while ensuring compliance with FDA regulations, GCP, ICH, and Company SOPs for all preclinical and clinical operations activities.

* Assesses study/project timelines, budget, and resources; and directly communicates and resolves potential roadblocks and/or delays. Provides study/project metrics on an ongoing basis to support study and project targets and deliverables. Provides oversight of study-specific Clinical Study Plans and contributes to the initial and ongoing risk mitigation/management for clinical trials.

* Leads the development and optimization of processes for bioequivalence (BE) or other clinical studies. Recommends new process opportunities and leads/supports process improvement initiatives. Proactively identifies, recommends, and implements solutions to problems and/or issues with personnel and/or processes across departments.

* Lead the vendor selection and review process. Leads vendor and Site contracting and manages change order processes, if requested. Strong vendor management to hold Service Providers accountable for performance.

* Responsible for scientific oversight and coordination of nonclinical PK studies supporting drug development and toxicological work with CROs for impurity qualification.

* Provides support and oversight to maintain and ensure the quality and completeness of study TMFs in compliance with GCP. Participates in the development of training programs and manages training initiatives for direct reports. Collaborates with training resources. Documents requirements and report completion.

* Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design.

MINIMUM REQUIREMENTS

EDUCATION / EXPERIENCE:

* Master s in scientific discipline required; pharmacokinetics, pharmacology or related field preferred.

* PhD / MD / PharmD preferred.

* Minimum of 15 years of relevant experience required, including at least 12 years generic pharmaceutical or related industry experience in pharmacokinetics or clinical pharmacology.

* Direct experience with clinical pharmacology summary documents required for Regulatory submissions.

* Knowledge of GCP, Clinical Research, Fundamentals of Project Management, working in a matrix-based environment is a must.

SKILLS / COMPETENCIES:

* Strong analytical skills; a strategic thinker, planner and implementer; proven track record negotiating with third parties.

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

* Working knowledge of statistics, data analysis and data interpretation.

* Experience with the operational aspects of clinical trials and related such as cGCP, ICH, FDA and EMEA regulatory requirements.

* Organizational and cross-functional collaboration skills.

* Proficient in Microsoft Office (i.e., Word, Excel, SharePoint and PowerPoint).

* Record of successful publications in the area of clinical pharmacology/pharmacometrics.

* Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required.

* Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans.

* Demonstrated ability to lead people.

* Demonstrated ability to manage multiple and diverse projects concurrently.

* Demonstrated ability to develop relationships and generate collaborations.

* Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment.

ORGANIZATIONAL RELATIONSHIP/SCOPE:

* This position reports to the Senior Vice President and Chief Scientific Officer Specialty Generics.

Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Apply Now