Harvard Job Description Sample
Associate Clinical Development Director-Ophthalmology
The Associate Clinical Development Director (Assoc. CDD) is responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. May be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.
- Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations 2)Provides clinical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3) In collaboration with appropriate Clinical Trial Team (CTT) members: a) Ensures clinical support of trials as needed b) Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead c) Manages patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead d) Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations 4) Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs 5) Supports development of TA strategies, as needed 6)May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities 7) Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members 8) Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 9) Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives).
Sr Scientist, Computational Biology
In addition to hypothesis-driven interrogation of such data there is a growing need to look at these data in an unbiased way in search of explanatory and predictive patterns. The application of causal and predictive models to 'omics data will play a critical role in the identification and validation of therapeutic targets. Use of these tools will also enhance our understanding of disease pathology and heterogeneity leading to more tailored treatments for patients and enhanced clinical study designs.
The successful candidate for this position is expected to leverage different quantitative methods such as differential equation, network and Bayesian models to make fundamental contributions to understanding disease biology and therapy. The scientist will also be familiar with using and applying model-neutral statistical analysis methods from the area of bioinformatics and machine learning to integrate data and uncover novel signatures of associations between molecular and clinical phenotypes.
The scientist will be familiar with computational methods such linear and nonlinear solvers and simulations. The scientist will draw from a strong understanding of physical and information sciences, such as stochastic processes, information theory, and discrete mathematics. Despite having a quantitative background the successful candidate has a history of working closely with experimental scientists.
This position will be part of the computational and systems biology group that is part of the research and early development organization active in multiple stages of Biogen's drug pipeline. The candidate will work in a matrix with computational and systems biologists, and a rich community of neurologists, drug discovery chemists, high throughput screening scientists, biomarker scientists, and clinical development physicians and scientists.
Experience 2+ years working in a drug discovery organization using computational and quantitative methods is required. Deep understanding of experimental molecular biology and biochemistry, as well as modern high-throughput methods such as high dimensional cell sorting, next generation sequencing, and array technologies is required. Demonstrated ability to work collaboratively within multi-disciplinary teams is essential.
Excellent communication and presentation skills are required. Scientist is expected to translate the technical terminology of quantitative sciences into high level language understandable by scientists expert in other disciplines.
Track record of creativity, innovation, and delivery of real world value, including relevant peer-reviewed scientific publication, is required. Hands-on experience with the information technology aspects of data collection, organization, and integration, as well as the systems and tools required for data analysis is required. Prior experience in neurology is desired but not necessary
Sr Manager, Accounting
Support Sr. Leadership in Worldwide Medical's functions (US Medical, Scientific Partnership, Medical Research)
Lead all planning (Annual Budget, Long Range Plan) and budget oversight for one of Worldwide Medicals functions
Prepare and present monthly financial reporting packages for cost center managers and VPs, including detailed analysis of variances to budget and forecast, conduct research into drivers of variances.
Execute the Month end/Quarter-end close process, including creation of journal entries, balance sheet reconciliations, and variance analysis for Worldwide Medical selected functions.
Finance lead for certain Medical Therapeutic Areas (MS, AD, SMA)
Liaise with external auditors.
Continually identify opportunities to drive improvement in the areas of accruals, analysis, financial diligence and reporting by leveraging systems and other resources
Strong financial acumen with a value creation mindset.
5-7 years accounting and finance experience
Ability to work in a fast-paced environment
Compelling communication and presentation skills and demonstrated success building partnership across organizational boundaries. Must be able to effectively work with non-finance colleagues across the organization.
Strong written and oral communication skills including the ability to communicate effectively and professionally with executive management and across diverse groups
Knowledge and understanding of U.S. GAAP and SOX compliance requirements
Proficiency with ERP system such as Oracle or SAP required, and experience with reporting and forecasting tools such as Hyperion Planning or Hyperion Essbase
Above-average proficiency with Microsoft Excel
Sr Medical Director, MS, Early Clinical Development
The successful candidate will have an exceptional opportunity to influence the research and early development pipeline with the following purpose:
1.To play strategic and clinical leadership role within the MS Research Unit that is responsible from idea to end of proof of concept.
To lead early clinical program teams and support the late development and eventual worldwide commercialization of these agents
2.To contribute to growth of the pipeline through identification and diligence of in-licensing opportunities
Provide strategic leadership for assigned clinical programs through integration of
o Own clinical and scientific expertise.
o Lead clinical science behind CDP, including biology of the disease, clinical/strategic appropriateness of each study, and critical details of each study including doses selected and measurement characteristics of endpoints
o Input and advice from medical and patient advocacy groups.
Accountable for overall quality/integrity of the comprehensive Clinical Development Plan, from first-in-human through Proof of Concept studies, including:
o Establishment of clear decision nodes and criteria, which drive to successful transition to pivotal clinical trials in support of a defined product profile through the integration of scientific, regulatory, operational, and commercial/reimbursement considerations.
o Scientific and operational collaboration in the context of project teams with colleagues from and other functions within the organization in support of program goals,
o As required, establish external collaborative relationships to augment internal Biogen capabilities in support of early-phase development programs
Engage with Regulatory agencies--Represent clinical development at FDA, CHMP, PMDA and other national agencies
Provide strategic and clinical insight to the MSRU leadership team. Share responsibility and accountability for delivery of MSRU goals.
Provide mentorship, coaching and management of clinical physician and clinical scientist.
Actively survey scientific landscape in biology and clinical science; identify external opportunities for in-licensing and support clinical and scientific diligence.
The individual is expected to
Have experience of clinical research and ideally laboratory research.
Have relevant experience in industry or academia driving clinical development programs.
Have established peer level relationships with therapeutic area opinion leaders worldwide.
Be confident and persuasive discussing the science of new research approaches, clinical endpoints, protocol design, or data interpretation and be open to new ideas to accelerate programs and increase the probability of success.
Have demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
Have demonstrated strategic and critical thinking.
Have excellent communication skills (oral and written) and excellent organizational skills.
Have the ability to lead directly and by influence, including strong problem solving and conflict resolution
Senior Administrative Assistant
A global healthcare leader, Novartis, has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, and performance driven people. All of this makes Novartis one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
We are seeking a dynamic individual for a full-time role to provide high-level administrative and planning support to the Office of the President located in Cambridge. The candidate must have excellent communication skills, both written and spoken English, and have the diplomatic skills to work in a professional manner with people, both internal and external, across several management levels. S/he must have sound judgment; be well-organized with a strong emphasis on attention to detail; be a fast learner; and be able to handle several projects in parallel and follow through on expectations, with minimal supervision. S/he should be self-motivated, proactive in anticipating needs and thinking beyond the guidelines provided, and able to work independently and contribute as an effective team member.
Accuracy and adherence to deadlines in a fast-paced environment is essential.
Providing general administrative support to the Office of the President, such as:
Arranging meetings, scheduling appointments and interviews
Organizing travel plans
Preparing expense reports
Managing office supplies
Designing and updating SharePoint site and websites
Maintaining working knowledge of relevant Novartis policies and procedures; may act as a source of information on organizational policies and procedures.
Setting up and managing filing system as appropriate (e.g., contracts, in-voices, purchase orders etc.)
Clinician Director, Early Clinical Development, I&I
The overall role of the Early Clinical Development (ECD) Clinician is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for first in man (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic areas: Immunology and Inflammation
The ECD Clinician will participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. The ECD Clinician will work with other functional disciples to ensure the full scope and remit of ECD is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).
The individual will be involved with clinical drug development activities from FIH through POC. They will be a key member and/or contact for project teams to ensure collaboration and seamless connectivity between ECD, Research Units and Global Product Development (late stage development and study operations).
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
Supports execution for all post-FIH programs through proof of mechanism and proof-of concept
Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
Sit on project teams from FIH/POM/ESoE through POC trial completion to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
Support preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
Collaborate between the clinical team and ECD by maintaining open communications between the two groups and ensuring successful program completion.
Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas.
Coordinate with other clinical research activities in ECD and greater World-Wide Research and Development (WRD) organization.
Develop effective collaborations with key partners in Pfizer Discovery Research Units (RU) as well as Centers for Therapeutic Innovation (CTI) and Precision Medicine.
Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, precision medicine and development operations.
Partner with Precision Medicine as needed to ensure that biomarker plans are enabled in all relevant therapeutic area programs to help determine early signs of efficacy and proof of concept, patient stratification, etc.
Establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results.
Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
Requires PhD, PharmD, MSc (relevant experience in Immunology and Inflammation, Cardiovascular/Metabolic, Neruosciences, or Rare Disease preferred)
Deep understanding of the biopharmaceutical environment and the drug development
5-8 years of relevant experience in drug development; 3-5 years of relevant experience in a clinician type role with a proven track record executing development programs to completion or targeted milestone
Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management
A clear working knowledge of the clinical development process
Demonstrated ability to support the formulation and execution of clinical strategies; Experience in generating hypothesis driven research investigations
Biopharmaceutical experience as a medical monitor and clinical lead for translational medicine projects across therapeutic areas is desirable.
Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.
Ability to analyze and interpret complex datasets.
Ability to operate with a sense of pace and urgency in matrixed project teams.
Exercises initiative in meeting goals and drives innovation in projects.
Demonstrated scientific productivity (publications, abstracts, etc.).
Good communication and presentation skills as well as proven scientific writing skills.
Results-oriented with demonstrated track record of success in clinical development
Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography
Entrepreneurial mindset with the ability to bring creative solutions to challenges
Ability to think and frame problems strategically
Quick action taker, able to involve the right team members in the right situation at the right time with a fit for purpose attitude
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Other Job Details:
Last Date to Apply for Job: April 1, 2018
Eligible for Relocation Package: yes
- Eligible for Employee Referral
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Senior HR Partner – Associate Director
The Senior HR Partner is responsible for implementing the strategic design, evaluation and coordination of HR practices within NIBR. Acts as key and trusted HR Partner to leaders and managers within the client group working to understand the HR needs and requirements, and readily translates internal client needs into successful HR initiatives. This includes accountability with the client group to reach operational and strategic objectives.
Evolve the strategy
Understands the organization and its objectives, challenges and initiatives.
Actively contributes in management meetings to provide human resources perspective on key organizational issues. Consults with managers and leaders to influence and facilitate the development of their organizational priorities and related change initiatives.
Identifies, analyzes, synthesizes and presents insight into key issues in order to enable good decisions. Positions information in a meaningful way to drive systemic change and may result in a request of the organization.
Known as having a unique perspective, thoughtful insight as organizational people strategies are designed.
Coaching leaders and leadership teams for the purpose of developing teams toward their scientific goals
Calls out challenges within the culture and acts as a change agent. Provides tools for the managers and leaders to use in leading the organization through transition. Takes a broader view of the impact of the change in order to identify dependencies. Takes steps to work through the dependencies with the organization.
Aware of motivating and demotivating factors for top talent and integrate into development strategy.
Utilize HR strategy and programs in service of the line clients vision and strategy
Solves complex situations. Infrequently needs HR Manager/Leader involvement. Informs Leader when situation has broader implications.
Devise actions to continuously develop the organizational design and culture. successfully lead organization through all transitions of a change event
Brings own expertise and partners with expertise groups (T&OD, Comp, D&I, Staffing) to bring full HR playbook to line functions
Operationalize the Strategy
Translates information and HR insight to systemic diagnosis at an organizational level and supports organization's development
Proactively identifies major, complex problems and builds effective solutions, including appropriate delegation and follow-through.
Uses appropriate communication techniques within team and with the business including information sharing, selling, consulting, and negotiating on difficult emotional and/or complex situations.
Counsels key leaders and influences the communication strategies for the organization (i.e. content, timing, execution and key messages).
Guides line client leaders and organizations in restructuring decisions and execution, including REKO and Steering Committee presentations
Drive engagement and utilization of HR Programs
Drives with line managers and leaders people strategies that identifies and develops top talent, using Talking Talent, Organizational Talent Review, and succession planning focusing on leadership development, challenging work opportunities, job design, trainings and assessments. May challenge business needs, internal equity and encourage the Leadership Team to gain broader and global perspective around organizational decisions.
Design and lead methodology and approaches for situations like change events, new initiatives, team events and workshops, HR Programs and activities
Interpret compensation philosophy and reward strategy and support the line organization in development of recognition strategies that facilitate and support the attraction and retention of top performers.
Collaborate and support of Corporate and Division-Wide initiatives; such as Cross Divisional policies & programs, GJFA Alignment initiatives, GES, etc.
Conduct roll-up and overview of HR Cycle activities, such as Talent and Development activities/ learning nominations, global salary review, etc. Educate and facilitate the implementation of a performance culture.
Work requires collaboration and the development of strong partnerships with HR contacts. Influences definition of the partnering relationship. Utilizes broader perspective to ensure right outcome. May need to challenge the thinking while preserving the relationship.
Takes advantage of opportunities to share best practice and knowledge sharing across HR organization.
Advocates for managers and employees in ensuring a positive employee experience. Provides effective employee relations and performance management consulting that helps build independent management behavior.
Addresses escalations and evaluates high-risk Employee Relations situations. Frames risk strategy for business leaders consideration. Coaches leader on balancing organizational vs. corporate impact.
Handles challenging and sensitive issues such as senior leader performance issues involuntary terminations, and Business Practice Office concerns (e.g. harassment claims investigations). Support the performance management challenges for Sr. mgmt. population, including difficult non-voluntary terminations where required./ Effectively leading challenging ER situations such as those assigned by the Business Practice Office, conducting investigation through resolution committee activities
Sr. External Data Analyst
The Senior External Data Analyst is responsible for managing the acquisition, processing and curation of non-Biogen sourced study data, including imaging, clinical/ phenotypical, eCOA and digital/ wearables. The Analyst will be responsible for ensuring data transfers follow quality standards, and coordinating with other stakeholders in R&D to ensure acquisitions satisfy expected analysis plans. Collaborates with external vendors, Biogen partners and patient organizations responsible for collecting the data. Defines and implements data transfer, quality control and curation processes. Works with other External Data team members to ensure consistency of quality control methods and processes across disparate types of data sourced external to Biogen. Assists the Principal External Analyst in the development of processes and tools to ensure quality, and is responsible for collecting and reporting these metrics to management. Works with Specialty Programming to apply industry standards, where possible, to enhance usability of external data. Accountable to deliver work assigned per expected quality and timeliness. Participates in process improvement projects and initiatives, which impact enterprise collection and use of external data. Coordinates with R&D IT to implement and maintain infrastructure to make the external data available for analysis across R&D.
This requisition will primarily be focused on imaging (e.g., MRI, PET, SPECT, CT) data, with overlap to the phenotypical/ clinical and other types of external data required to use the imaging data in research analytics.
1.Manages external data acquisition plans in coordination with Data Management, Biostatistics, Specialty Programming and other R&D Stakeholders as necessary. Manages relationships with external organizations' operations teams to acquire data.
2.Researches industry best practices and establishes processes, tools, systems and protocols for the acquisition of external data. Manages the associated documentation. Consults on process improvement initiatives, special initiatives and capability projects both inside and outside of Data Management. Establishes and maintains data curation standards associated to non-Biogen collected external data.
3.Coordinates with Specialty Programming and R&D IT to establish and maintain technical systems and infrastructure for the acquisition and loading of external data sources. Works with the External Data Analyst to ensure the technical infrastructure is configured to load external data.
4.Collaborates with external organizations on standard and source-specific data transfer agreements/ specifications and methods. Coordinates with Legal and Strategic Sourcing (as necessary) to ensure data use agreements are aligned to corporate standards. Coordinates with internal functions (IT, Data Governance, Data Privacy etc.) to ensure data use requirements are satisfied.
5.Coordinates with External Data Analysts and Specialty Programming to assess the quality and completeness of the external data. Works with external organizations to resolve quality issues discovered in source data. Works with External Data Analysts to ensure uniformity in quality deliverables, across all types of external data.
6.Defines quality metrics; measures and reports to internal R&D stakeholders and associated external organization to ensure quality data/ deliverables. Collaborates with DM External Data team, and relevant R&D functions, to ensure harmonization of standards and standard practices, as applicable to external data sources.
5-8 years relevant work experience with a focus on imaging data management and/or external data acquisition/ analysis
Experience with processing medical imaging data types, both processed and raw (DICOM) including but not limited to XRAY, MRI, PET, DEXA, etc.
Deep understanding of drug development and biopharmaceutical industry, with emphasis on role of imaging data
Experience using hardware and software used to curate, process and analyze imaging data
Experience with scripting/ coding languages, to affect the transfer of imaging files and the curation of metadata for data quality control and to describe the data asset (R, SAS, Python, etc.)
Experience developing and implementing process and data standards
Strong project management skills, and ability to effectively lead, collaborate and communicate across diverse group of imaging data stakeholders (scientific, technical, operational)
High attention to detail including proven ability to manage multiple, competing priorities
Experience establishing and managing relationships with external vendors and organizations for the acquisition of external data
Demonstrated ability to establish and manage effective business relationships with internal and external stakeholders
Demonstrated ability to influence without authority
Excellent written and oral communication skills
Compliance Officer- Medical/ R&D/ Po&T
The Compliance Officer will be responsible for leading the Company's Corporate Compliance Program within the global functions of GM, R&D and PO&T across all elements of a robust Compliance Program. The Compliance Officer will carry out regular and thorough risk assessments, policy and operating process development and refinement, training and awareness of global compliance policies and SOPs, and monitoring and assessing of the design and operating effectiveness of the established controls. The Compliance Officer will also advise on day to day compliance topics, ensure senior management is aware of risks affecting their business, and review the internal and external landscape for emerging risks. This person will be the principle liaison between affiliate (country based) Compliance Officers and the Corporate Compliance global team with respect to medical affairs, research, manufacturing and development activities. This role will also provide functional management oversight of certain global policy topics such as Post Marketing Studies and IIT's, MSL/sales Interactions, Global Expanded Access and Grants and Donations.
Serve as the Compliance point of contact for GM, R&D and PO&T management and employees - providing guidance on the Code of Business Conduct, global and functional specific Policies and Standard Operating Procedures (SOP's) and integration of these policies and SOPs as they are implemented.
Lead certain global projects for which activities are concentrated within the GM, R&D and PO&T teams and participate on other global projects.
Perform regular compliance monitoring of identified high risk activities and areas at a global functional level and provide reports to Corporate Compliance and functional management as requested. Develop risk-based monitoring plans and perform annual Risk Assessments. Advise and discuss with relevant management risk trends, analysis and recommended program, control and business process enhancements.
Advise GM, R&D, and PO&T leadership and other levels of management of potential compliance risk areas and recommend appropriate action plans; provide Corporate Compliance input into regular functional management meetings; set functional compliance strategy with GM, R&D, and PO&T management; pro-actively raise awareness and communicate about compliance with Management and other business partners.
Provide awareness and ongoing education on Compliance related topics, policies and SOPs; design risk-based training curriculums; support awareness tools and communication plans.
Ensure key compliance records are well-organized, stored and easily accessible; ensure the systems to support Fair Market Value (FMV) calculations are accurately provided, and provide guidance on appropriate support for grants and sponsorships in close co-ordination with Legal, including through participation on grants committees as required.
Management of Budget: annual program management plans; specific project plans; deploy resources in accordance with allocated budget.
Other job duties that may be assigned. May be modified at any time as business needs require.
Minimum 5-7 years' experience in BioPharma industry, 4-6 years overseeing complex Corporate Compliance organizations (optimally globally).
Excellent communication and inter-personal skills
Excellent analytical, data synthesizing skills
Strong strategic thinking capabilities – complex problem solving
Ability to work well in team environments with diverse and cross-disciplinary stakeholders.
Strong program and project management skills
VP, Regulatory CMC
Reporting into the EVP of PO&T, the successful executive in this role will build an effective relationship with the PO&T leadership and skillfully and creatively balance the needs of regulators and the organization to help get to approvals, both for initial regulatory submissions and those that are part of Biogen's commercial worldwide market expansion plans.
The Vice President of Regulatory Affairs, CMC represents the Company with domestic and international regulatory authorities, industry organizations, contractors and corporate partners. S/he provides regulatory guidance for various corporate wide teams/committees. The VP REG CMC leads his/her organization to successfully maintain the compliance of regulatory filings, manage effectively the regulatory implications of changes, and continuously improves the efficiency of regulatory operations in support of Biogen registrations and regulatory commitments. The VP REG CMC provides leadership to enable the full realization of the team's remit to influence, enable, and sustain innovative Biogen therapies across the world. The incumbent is able to approach the global regulatory landscape with the capacity to adapt, innovate, and develop optimal strategies to advance and maintain the registration of Biogen drug therapies with optimal effectiveness and compliance.
Create future vision for the REG CMC Team; define directions, strategies, and plans for implementation. Communicate the vision and plan to stakeholders across the organization. Fully implement outsourcing model consistent with a strategic plan to optimize the use of internal versus external resources so that the most complex regulatory activities are managed internally.
Ensure that goals of the REG CMC team are met. Direct the organization in the preparation of quality submissions that optimizes compliance with regulatory expectations with the flexibility to manage change with minimal bureaucratic burden. Work with colleagues throughout Regulatory Affairs to ensure alignment in approach and timelines as needed Accountable for accuracy and content of submissions and communications with Regulatory Agencies.
Build strong working relationships with Senior Leadership in PO&T, and effectively influence and bring along this group. Evaluate opportunities for moving the organization forward, and bringing innovative approaches to the work.
Partner with the PO&T organization and R&D's Regulatory Sciences leadership to formulate goals and priorities for focus regarding regulatory policy advocacy.
Provides an influential voice for Biogen in key industry associations
Develop a strategy for implementation of regulatory policy issues in conjunction with key stakeholders across Biogen.
Develop and maintain highly capable and dedicated regulatory team. Manage and provide direction and mentorship to the team. Continue to build out capability in areas where expertise is needed.
Serve as an integral member of the leadership team on the continuing evolution of the department, contributing to and leading department initiatives. Build effective relationships with other members of the Regulatory leadership team, and collaborate across the regulatory team to ensure world-class filings.
Drive the recognition of Biogen as a leader in Regulatory Science. Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. Effectively balance the interests of the organization and the regulatory agencies to successfully resolve disagreement.
15+ years of technical leadership experience biotech/pharmaceutical industry. Minimum of 7 years in Regulatory Affairs.
Comprehensive knowledge of applicable domestic and international regulations. Experience and knowledge in the preparation and global assessment of major regulatory submissions and supportive amendments or supplements.
Demonstrated strategic leadership through proactive engagement with the senior stakeholders, and through proactive communication at key meetings with PO&T leaders as well as external agencies.
Ability to proactively formulate and communicate risk based approaches to ongoing work. Willing to step up and confidently analyze the pros and cons and present recommendations.
Strategic, able to see the big picture and consultative to client groups.
Outstanding credibility and influence with senior executive leadership, executive peers, and other internal and external stakeholder groups, and communicate in a clear, concise and effective manner.
Proven track record of leading and managing a multidisciplinary team, and guiding the team effectively.
Strong interpersonal skills and ability to work with cross-functional teams.
Demonstrated experience leading in a highly matrixed, dynamic global health care organization.
An individual of unquestioned personal and business integrity who will be viewed as trustworthy both within the company and externally.
Strong track record of outstanding decision-making abilities—able to make decisions logically, methodically, and quickly (as appropriate).
Broad technical knowledge across both biologics and small molecules.
Proven success in managing complex development portfolios and project plans.
Proven track record of coaching and developing internal talent.
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