47 clinical director jobs found

Merck Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineering...

Merck Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineering...

Alkermes, Inc. The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes' diverse small molecule drug candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements to progress candidates through clinical development and is recognized by internal peers for his/her scientific contributions and deliverables (within discipline) to Discovery and Development programs. The individual has specific expertise in one or more areas relevant to nonclinical safety evaluation, shows competency in all aspects,...

Alkermes, Inc. This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources. This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. Travel requirement of 40% - 60% Responsibilities This position will : Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites...

Alkermes, Inc. This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical responsibilities in the clinical department involved in the development of therapies for neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statisticalanalysis and high-quality data to support decision making in clinical trials. Responsibilities Reporting to the Executive Director of Study Data Standards and Quality Management (SDSQM), the Director of Submission Consultation (SC) provides leadership for the successful...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statisticalanalysis and high-quality data to support decision making in clinical trials. Responsibilities Reporting to the Executive Director of Study Data Standards and Quality Management (SDSQM), the Director of Submission Consultation (SC) provides leadership for the successful...

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy. This role reports to the Executive Director, Regulatory Strategy. Responsibilities Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams Develop and implement global regulatory strategies for pipeline drug...

Alkermes, Inc. Alkermes has an exciting opportunity for a talented scientist to join our Research Organization as a Director to help lead medicinal chemistry efforts from target ideation through to candidate nomination for neurological disease indications. The desired candidate will be a recognized expert in successfully initiating and managing the medicinal chemistry activities inside a given portfolio and will play a key strategic role in shaping discovery direction and compound design strategy. The candidate will have a proven track record of utilizing structure-based drug design (SBDD) to rationally design compounds that have progressed to candidate delivery. Additionally, the candidate must have direct experience of working with both internal and external partners (e.g., CROs) to facilitate medicinal chemistry activities. Exceptional cross-functional communication skills as well as experience in leading drug discovery teams are necessary attributes. Responsibilities...

Alkermes, Inc. Alkermes is seeking an experienced Program Manager to support our ALKS 2680 program which is currently in Phase 2 development and preparing for Phase 3 and registration. ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy and idiopathic hypersomnia. This person will work closely with members across our organization including areas such as research, pre-clinical, clinical, pharmaceutical development, regulatory affairs, medical affairs, commercial, operations, policy and government affairs, patient engagement and corporate communications, as well as the senior management team to orchestrate development and execution of our fully-integrated program strategic and operational plans to support key corporate goals including the development and ultimate approval of ALKS 2680 as well as identify and execute a comprehensive lifecycle management program. This is a hybrid on-site...

Alkermes, Inc. In this leadership position, the Senior Director, Statistical Programming will serve as the head of statistical programming who oversees all statistical programming activities to support Alkermes' growing portfolio. This leader will provide guidance on statistical programming technical skills, selecting appropriate and innovative approaches to produce high quality deliverables for in-house and outsourced projects. This role will manage hiring, resource planning and setting strategic vision for the statistical programming group as well as assist on complex deliverables. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work Duties and Responsibilities: Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical...

Alkermes, Inc. The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently...

Alkermes, Inc. The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives. The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing individuals and highly effective teams. This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to...

Alkermes, Inc. The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases. You'll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization. Key Responsibilities: Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables. This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities. Serve as submission manager and primary contact for publishing vendors and internal stakeholders....

Alkermes, Inc. We are seeking a highly motivated and strategic individual for a Director of Health Economics and Outcomes Research (HEOR) role at Alkermes. This is an exciting, visible, and highly collaborative opportunity where you will play a pivotal role in executing on evidence generation plans in support of Alkermes' most advanced pipeline program in sleep-wake disorders. You will report to and support the Head of HEOR in the delivery of research activities and development of materials to support engagements with key stakeholders, including physicians, regulatory agencies, reimbursement bodies, and patients/advocates. The ideal candidate will have a strong technical background in HEOR, excellent data science and visualization skills, great written and verbal communication skills, and a proven ability to foster and manage internal and external relationships effectively. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees...

Alkermes, Inc. Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary. Responsibilities Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US...

Merck Job Description The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases...

Merck Job Description The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases...

Merck Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for a Sr. Specialist - Process Engineer to lead...

CSL The Opportunity: Reporting to the Director CSL Behring, Financial Analysis, as the Manager, Financial Analysis , you will be a part of the Financial Analysis team within the Finance FP&A group. You will provide support for business cases, apply advanced analytics to predict the financial impacts and implications of changes or potential changes to capital projects and portfolios, product mix, yield and supply, major operational, supply chain or network changes and other major changes to the business. You will complete advanced analyses and modelling that is not offered as a "standard" output from the FP&A Reporting & Insights team. In addition to Financial Analysis, you will contribute insights, narrative, and advice on the analysis to support understanding and decision-making related to the financial and operational aspects of the situation or opportunity. This is a hybrid role, which offers a combination of an onsite and remote work schedule The Role:...