Mallinckrodt Pharmaceuticals Director, Clinical Studies in St. Louis, Missouri
Director, Clinical Studies
JR000010951 Director, Clinical Studies (Open)
Webster Groves (Pharma) - USA038
St. Louis, MO
The Director, Clinical Studies 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 Director, Clinical Studies 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 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 (preferred) or remote.
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 with guidance from the Senior Director, Regulatory Affairs.
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. Recommend 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.
Education / Experience:
Master’s in scientific discipline required; pharmacokinetics, pharmacology or related field preferred.
PhD / MD / PharmD preferred.
Minimum of 10 years of relevant experience required, including at least 7 years relevant 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.
This position will report to the Senior Director, Regulatory Affairs and manage a team.
This role interacts at all levels in the organization both within the function and cross-functionally and will support partnerships with contract research organizations (CROs), other vendors and clinical sites.
Approximately 10-25% domestic and international travel is required.
This position is eligible for relocation.
Normal office setting.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.