Total 11 Director/C-Level Admin Executive job vacancies in 5000 - Vertex US - Boston

Job Description

Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Nephrology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategy across the current APOL1-MEDIATED KIDNEY DISEASE (AMKD) and for the development of the life cycle management plan. The individual will partner with the International and North America regions to drive globally aligned medical brand and evidence generation plans which reflect country and regional insights and needs. This individual must work effectively with his/her cross-functional counterparts in Development, Research, and Commercial, and will sit on the Renal Disease Strategy Team to define and implement an encompassing strategy to support enrollment in clinical trials, build the key expert’s network and translate clinical practice into actionable strategies for the potential introduction of a new therapy for a little-known medical condition that requires genetic testing.

 
Key Responsibilities:

• The Executive Director, AMKD Global Strategy will have global responsibility to build the Global Medical strategy for this asset.

• Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance.

• Build the right relationships with experts in the field for the understanding of the clinical landscape.

• Execute the Global components of the medical strategy plan.

• Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partner functions to identify evidence gaps and coordinate evidence generation to generate data in support of global product initiatives.

• Ensure all Medical Affairs initiatives are aligned with overall brand plans and in compliance with corporate polices and regulatory requirements.

• Determine staffing requirements for the group and successfully recruit, develop and retain an effective team. The successful candidate will evaluate and update process and operating procedures for this group that are consistent with general guidance already in place for the organization.

Minimum Qualifications:

• The successful candidate will have a medical degree or PhD from a well-regarded institution and at least 7 years of experience in industry, with at least 3 of those in an industry managerial role leading clinical and/or medical programs.  The ideal candidate will have nephrology training and clinical practice experience.

• In addition to deep technical competence, she/he will exhibit sound business judgment with an understanding of the significant financial investments and the ultimate impact that the role has on product opportunities and on the Company.

• The Executive Director, AMKD Global Strategy will be a natural leader, possessing the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment.

• The successful candidate will possess excellent communication and relationship skills.  S/he will communicate with a style that is clear, complete and concise.  S/he will have well-established networks and be able to develop and maintain strong professional relationships internally and externally by gaining credibility and confidence with others.

• S/he will exhibit a high level of directed energy toward developing and achieving objectives that will inspire others.

Company Information

Job Description

Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Hematology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies for the first FDA approved CRISPR-cas9 medicine (Exa-Cel) for the treatment of Sickle Cell Disease and Infusion dependent B-Thalassemia, including the development of the life cycle management plan. The successful candidate will be an experienced people manager who is passionate about developing talent to whom the HEME Global Medical team will report to. The individual will partner with the International and North America regions to drive globally aligned medical brand and evidence generation plans which reflect country and regional insights and needs. This individual must work effectively with his/her cross-functional counterparts in Development, Research, and Commercial, and will sit on the HEME Disease Strategy Team to define and implement the medical affairs strategy for Exa-Cel.

 
Key Responsibilities:

• The Executive Director, HEME Global Strategy will have global responsibility to build the Global Medical strategy for Exa-Cel.

• Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance.

• Execute the Global components of the medical strategy plan.

• Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partner functions to identify evidence gaps and coordinate evidence generation to generate data in support of global product initiatives.

• Ensure all Medical Affairs initiatives are aligned with overall brand plans and in compliance with corporate polices and regulatory requirements.

• Determine staffing requirements for the group and successfully recruit, develop and retain an effective team. The successful candidate will evaluate and update process and operating procedures for this group that are consistent with general guidance already in place for the organization.

Minimum Qualifications:

• The successful candidate will have a medical degree or PhD from a well-regarded institution and at least 7 years of experience in industry, with at least 3 of those in an industry managerial role leading clinical and/or medical programs.  The ideal candidate will have sub-specialty training in Hematology / Transplant medicine.

• In addition to deep technical competence, she/he will exhibit sound business judgment with an understanding of the significant financial investments and the ultimate impact that the role has on product opportunities and on the Company.

• The Executive Director, HEME Global Strategy will be a natural leader, possessing the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment.

• The successful candidate will possess excellent communication and relationship skills.  S/he will communicate with a style that is clear, complete and concise.  S/he will have well-established networks and be able to develop and maintain strong professional relationships internally and externally by gaining credibility and confidence with others.

• S/he will exhibit a high level of directed energy toward developing and achieving objectives that will inspire others.

Company Information

Our Company has one exciting mission: To entertain the human race and provide an unforgettable escape. Delivering excellence for our guests, and contributing to building and sustaining our communities, requires collaboration from diverse teams of world-class talent. Our iconic MGM Resorts brands offer a wide variety of exciting career opportunities, each with access to unlimited growth.

Primary Purpose:

The Executive Director of Horticulture & Floral develops and executes the strategic plan for the department consistent with the strategic vision of the division's Center of Excellence and property leadership, as well as establishes the parameters that empower management with the authority to accomplish the duties of their assigned positions.

• Develops and monitors division operation budgets through the evaluation of projects and labor to remain within budgetary constraints, ensure profitability, and meet targeted deadlines.

• Provides leadership and direction in the execution and measurement of guest service standards within Horticulture & Floral Operations to include the management of all technical trade classifications (Gardeners, Laborers, Leads, Coordinators, etc.) consistent with the company's core service standards, brand attributes, and established guidelines/standards.

• Directs and manages all functions performed within Horticulture & Floral Operations.

• Works closely with department management to ensure the establishment of sound operational business practices that produce positive methods to ensure all projects/assignments produce quality results.

• Provides management guidance and technical direction in the resolution of problems associated with maintenance and landscaping issues.

• Directs and manages accountability processes for division; ensures compliance with company policies, legal requirements, and collective bargaining agreements.

• Provides leadership for the division’s Human Resources responsibilities for assigned department(s) to include creating a work environment that promotes teamwork, performance feedback, recognition, mutual respect and employee satisfaction; quality hiring, training and succession planning processes that encompass the company’s diversity commitment.

• Mentors and coaches, the division staff in additional tasks/responsibilities to optimize advancement opportunities.

• Ensures compliance for all required health, safety, and environmental programs for the division.

Minimum Requirements:

• Bachelor's Degree or equivalent experience

• 4+ Years of Prior Relevant Experience

Join us as we work to create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all.

https://www.athenahealth.com/careers/equal-opportunity

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Global Safety Head, Obesity

Live

What you will do

Let’s do this. Let’s change the world. In this vital role as the Executive Director, Global Safety Head, you will serve as the safety expert for Amgen’s obesity products globally and are accountable for the safety strategy and major safety deliverables for each product. You will lead the obesity safety teams and are accountable for the staff management and resource planning/allocation.

You will serve as a core member of Global Patient Safety Leadership team and will support the Head of Global Patient Safety (GPS) in the establishment of a highly effective global safety organization in full compliance with worldwide regulations.  This role reports into the Head of Global Patient Safety. 

Responsibilities:

• Serve as Safety expert in Obesity

• Accountable for providing strategic oversight and direction for all regulatory safety responses or strategic deliverables, including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs

• Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and ensures Therapeutic Area (TA) staff provides ongoing monitoring of safety profiles for Amgen products worldwide

• Chairs and participates in safety governance meetings per Standard Operating Procedures and Manuals

• Oversee Obesity Safety input to contractual agreements with Business Partners and CROs

• Works cross-functionally with Development and Regulatory TA Heads to reach issue resolution

• Provide safety oversight, strategy and guidance to therapeutic areas and other groups within Clinical Development, Medical Affairs, Regulatory and the commercial organizations

• Management of the Obesity safety teams providing direction and allowing appropriate prioritization of resources to achieve goals

• Recruit and retain talented safety professionals and provide coaching, mentoring, and development of staff

• Ensure staff are compliant with Amgen corporate and departmental training

• Contribute to Global Patient Safety goals in development

• Participate in budget and headcount planning

• Leads or sponsors significant cross-functional projects, initiatives or training

• Inspection Readiness

• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Basic Qualifications:

• MD or DO degree from an accredited medical school AND

• Five (5) years of industry or academic research AND  

• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• PhD with 15 years of directly related experience

• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

• Previous product safety experience and knowledge of clinical trials and drug development

• Knowledge of Obesity patient populations and drug classes

• Proven history of effective leadership with a matrix organization

• Issue and crisis management

• Strategic leadership ability and capable to manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects

• Understanding of international drug safety regulations, global pharmacovigilance and product safety processes

• Knowledge of general medicine, clinical care, and principles of epidemiology

• Influencing skills with capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels

• Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives

• Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting

• Identifying diverse, qualified successors for key positions

• Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $317,452 - $360,254.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgen’s Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Job Description

General Summary:

Reporting to the Vice President Total Rewards, the Executive Compensation, the Senior Director will support the design and administration of Vertex’s executive compensation programs and manage all day-to-day aspects of the executive compensation function. The position will ensure the appropriate
compensation programs and processes are in place to support Vertex’s global growth and strategic business objectives.

Key Duties and Responsibilities:

• Provide technical expertise on executive compensation design, policies, procedures, regulations, and compliance.
• Develop, implement, and analyze executive compensation and benefit programs for executives and non-employee directors, including short- and long-term incentive plans, financial and tax treatment of compensation and benefit programs, and proxy disclosure and analysis.
• Benchmark executive compensation levels and design at peer companies, contributing to market analysis of executive level jobs to determine competitive positioning and prepare and provide data and analysis for use in compensation committee meetings or proxy filings.
• Monitor developments in executive compensation regulation, disclosure, proxy advisor policies and shareholder voting. Anticipate changes to keep apprised of federal, state, and local laws to ensure executive compensation programs are administered in compliance with policies and government regulations.
• Develop and maintain peer competitive intelligence for real-time understanding of competitive landscape leveraging various tools and subscriptions (i.e.; Equilar, ISS, etc.) and partnerships with internal data intelligence teams to advance Total Rewards peer intelligence.
• Build Excel models, develop executive Tally Sheets for CEO and Executive Committee, and conduct analyses using tools such as CAPIQ, ISS, Equilar, Fidelity, etc.
• Oversee and drive effective use and on-going development of support tools (off the shelf, subscription services, in-house built, etc.) to optimize executive compensation practices.
• Develop executive offers and continually enhance offer process in collaboration with Talent Acquisition for optimal effectiveness and efficiencies in accordance with Total Rewards principles. Oversee financial benefits to increase program effectiveness and understanding.
• Partner with Stock Administration and other internal partners to manage global equity incentives and Employee Stock Purchase Program driving program effectiveness and enterprise-wide understanding.
• Develop communications to ensure plan participants understanding of programs.
• Prepare and coordinate materials for presentations to senior management and Compensation Committee; collaborate with Legal, Accounting, Tax, and other external advisors.
• Conceptualize and oversee the development/maintenance of key performance dashboards using both internal and external benchmark data in order to measure performance and progress, support decision making, and drive positive culture change.

Knowledge and Skills:

• Bachelors Degree or equivalent relevant experience

Education and Experience:

• 12 years of functional experience in designing and managing executive and equity compensation programs on a global basis or the equivalent combination of education and experience
• Optimal mix of strong business and financial acumen, analytical skills, and technical skills to be the hands-on driver of day-to-day, tactical executive compensation and equity initiatives.
• Ability to build relationships across multiple functions and effectively present information to executives and employees
• Outstanding written and verbal communication skills; ability to concisely summarize complex topics for senior leaders, communicating with individuals of all levels and maintaining professional composure, and respectfully challenging the status quo
• Excellent presentation skills; ability to negotiate with and influence internal stakeholders
• Extensive experience with Microsoft Office Suite coupled with knowledge of executive compensation tools (i.e., Equilar and ISS) and financial tools (e.g., CAP IQ).
• Excellent analytical and quantitative skills, with the ability to interpret market data and make data-driven recommendations
• Strong communication and presentation skills, with the ability to effectively communicate complex compensation concepts to senior leadership and other stakeholders
• Strong project management skills, with the ability to manage multiple priorities and meet deadlines
• Strong attention to detail and accuracy, with a focus on delivering high quality work
• Ability to maintain confidentiality and handle sensitive information with absolute discretion
• Strong interpersonal skills, with the ability to build relationships and collaborate effectively with internal and external stakeholders
• Managing multiple projects and priorities in a fast-paced, changing environment.

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.  

#LI-EE1  #LI-Hybrid

Company Information

Career Category

Job Description

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be reporting to the Vice President, Global Value & Access and will lead the Inflammation therapeutic area within the Integrated Access Strategy function. This team is responsible for strategic planning to support value and access for all Amgen molecules in development, beginning in Phase I and extending throughout commercialization though to launch and lifecycle management across the Amgen portfolio. Additionally, the team is responsible for global strategic pricing, including recommendations for global price bands and launch sequence.

Each Integrated Access Strategy incorporates coverage and reimbursement, pricing, value evidence, and policy into the development of a strategic plan that supports the overarching commercial objectives and links to the clinical attributes of the molecule. This plan elucidates and communicates the strategies and tactics to secure and maintain access throughout the lifecycle of a specific molecule.

The Executive Director will lead a team of Access Strategy Leads who represent payer needs on the multi-disciplinary Product Team for one or more molecules. This will include the development of new plans as well as the update of prior plans to reflect changes in product data and/or the global payer environment. The Executive Director will also represent Global Value & Access on cross functional Therapeutic Area Governance (TAG) and be responsible for ensuring pricing and access considerations are embedded into the therapeutic area strategies.

Each member of the therapeutic area team led by the Executive Director must work collaboratively across functions to ensure a comprehensive view of his/her assigned products and create and maintain strong collaborative working relationships with key stakeholders. These stakeholders include colleagues in Health Economics and Outcomes Research, Operational Pricing, Advocacy, Health Policy, and Government Affairs and their respective Therapeutic Area heads for those functions represented on TAG (Research, Development, Regulatory, Medical, Operations, Marketing, and Project Management). The individual must also oversee and conduct relevant payer/pricing research and integrate clinical, market, and payer information to develop and communicate the plan.

In addition to product-specific responsibilities, each member of the team also participates in one or more cross-portfolio projects each year. These projects either serve to advance the team’s knowledge of and readiness for the global payer environment, support specific market or product assessments, or attempt to influence payer policy development. Examples include Payer assessments to support potential mergers/acquisitions, payer landscape in emerging markets, exploration of new payer trends (e.g., bundling), or development of a policy white paper to shape external price and reimbursement policies in the global arena.

Key responsibilities

• Make strategic recommendations with a cross-functional Therapeutic Area and Amgen First mindset. Within TAG, the Executive Director IAS will be accountable to Portfolio Governance (PG) for Long Range Scenario (LRS) for all PTs within the TA, and portfolio decisions up to pre-specified investment thresholds

• Assess commercial viability of early asset Target Candidate Profiles (TCPs), Target Product Profiles (TPPs) and programs as they approach Portal decisions (e.g., Commit to Registrational Studies Portal)

• Conduct situational analysis of external pricing and reimbursement environment and synthesize relevant information to develop strategic plans

• Develop and test value messages and value evidence with payers in order to determine the most compelling way in which to demonstrate and communicate product value to payers

• Conduct qualitative and quantitative pricing studies and to formulate price policy recommendations

• Formulate health policy strategy and implement these strategies to shape external pricing and reimbursement environment

• Review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree & 6 years of global pricing, reimbursement, access experience OR

• Master’s degree & 10 years of global pricing, reimbursement, access experience OR

• Bachelor’s degree & 12 years of global pricing, reimbursement, access experience AND

• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications 

• Direct payer experience and/or experience in product commercialization is desirable

• Strategic planning and health policy experience strongly preferred

• Executive presence, influencing and communication skills

• Ability to manage and lead sizeable (20 to 25), global team (US and Swiss based)

• Global product launch experience in market

• Experience negotiating with various governments

• Regional Lead experience (EU, ASIA, LATAM) is desirable

• Inflammation experience is strongly preferred

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $271,532 to $310,324. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Job Description

Executive Director/Senior Director, Global Commercial Strategy Pain

Boston, MA (3 days onsite, 2 days remote weekly)

Vertex Pharmaceuticals is seeking a Executive Director or Senior Director of Global Commercial Strategy reporting to the VP Global Commercial Lead for Pain to join our dynamic team in Boston, MA. The candidate will take responsibility for global marketing decisions and tactics that lead Life Cycle Management, portfolio and commercial strategy development whilst supporting the team on successful launches on the pain programs. This will involve shaping global commercial strategy in pain portfolio and developing both strategies and resources to be used by the Regions in their interactions with stakeholders for years to come.  The successful candidate serves as a voice of the community to ensure patients remain at the center of decisions.

The candidate will play a key role in leading the development of the Pain Portfolio strategy.  The role will have a strong focus on Vertex’s outlook in pain across assets, indications and geographies.   This role will integrate launch preparation for ‘Next in class’ molecules with New Product planning.  They will lead development of key deliverables of Pain portfolio strategy including the 3–5 year commercialization strategy. A member of the Early Pipeline team (PT), the coordinating body for the portfolio pipeline in pain, will work closely with cross-functional matrix colleagues to ensure attainment of corporate objectives. The candidate will be the ‘right hand’ to the commercial lead for Pain ensuring aligned commercialization position on pipeline for the Disease Strategy Team and senior leadership. The successful candidate is highly strategic, thrives in an environment of uncertainty and rapid change, demonstrates strong leadership, works effectively within cross-functional teams, and has a problem-solving mindset backed by strong analytical skills. The candidate must share our passion for science-based brands that can dramatically improve patients' lives.

As a senior member on the pain team, the successful candidate must be able to role model Vertex’s ethics & culture and be committed to developing the next generation of leaders.

Key Responsibilities:

• Lead and ensure successful development and implementation of the commercialization (midterm) and portfolio (long term) strategies including brand development, competitive strategy, go-to-market/launch, and lifecycle decisions for future launches. Execute in close partnership with the Regions, Market Access, Regulatory and Commercial Manufacturing.

• Deliver foundational insights about the evolving landscape of pain today and in future, with focus on patients and providers, managing external consultants together with Marketing Science and Market Access

• Execute key global initiatives to prepare the market, enable strong uptake and sustain commercial success.

• Play a key role on the Early PT, integrating commercial position into pain pipeline strategy. There will also be potential to lead ‘Next-in-Class’ PT.

• Support the Global Commercial Team by providing clear direction for the pain portfolio as the primary forum for commercial collaboration and alignment.

• Represent the Commercial team in projects led by others e.g. label development, initiatives, etc.

• Partner with RWE and HEOR to continually evolve our understanding of addressable patient populations, providing input to relevant cross-functional teams (ClinDev, GPMA, HEOR).

• As a senior member of Global Commercial Strategy Pain team they will provide a mentoring/role model to the team.

Qualifications

• Bachelor’s degree required, ideally in life sciences

• Typically requires 12+ years of work experience or the equivalent combination of education and experience  

• In country launch experience, particularly in small molecule/pain, US market experience required and multiple-market experience highly desired.

• Experience in global marketing, new product planning as well as commercial operations or analytics desirable, especially involving product launches.

• Demonstrated ability to work independently and manage initiatives that require collaboration across multiple functional areas.

• An entrepreneurial spirit and an ability to develop creative solutions to complex problems.

• Excellent communication skills

• A solid compliance mindset, demonstrated integrity on the job, embrace of the Vertex Values. 

• Vertex welcomes applicants from diverse backgrounds and promotes an inclusive work-place environment.

#LI-KM3

Company Information

Job Description

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.

Key Duties and Responsibilities:

• Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.

• Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.

• Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.

• Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.

• Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.

• Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.

• Reviews and provides oversight of safety sections of clinical study reports.

• Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.

• Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.

• Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Extensive knowledge of GCP, ICH and Global regulations.

• In-depth and comprehensive knowledge of General Medicine.

• Strong leadership skills with the ability to communicate effectively in a matrix environment.

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.

• Extensive knowledge of Benefit-Risk strategies and decision-making.

• Ability to multi-task, adeptly handling multiple demands.

Education and Experience:

• MD, DO or equivalent ex-US medical degree

• 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Job Description

Executive Director, Logistics, Supply Chain Management - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (Boston)

This critical senior position will be responsible for building and leading the Global Logistics Organization within the Commercial Manufacturing and Supply Chain (CMSC) Division. Vertex is rapidly commercializing a pipeline of exciting programs and growing our capabilities to support the supply chain and manufacturing of these therapies. The head of this group will be responsible for defining and delivering the global logistics strategy for commercial therapies and a set of complex pipeline programs.  This strategy includes logistics network design, validation planning and life cycle management for all modalities (small molecule and cell and gene therapies).   The Executive Director will establish logistics as a key strategic pillar to enable successful clinical development and commercialization.

The Executive Director has interaction and impact across multiple Vertex departments and will represent the logistics organization in several executive forums. The Executive Director is responsible for delivering successful product launches across all programs. The Executive Director will cultivate and leverage multiple cross-functional business relationships to deliver a robust logistics strategy.    

This role will report to the VP of Supply Chain Management within the Commercial Manufacturing and Supply Chain (CMSC) division. This supply chain leadership position will be responsible for identifying future capabilities required and building out a high performing, diverse team focusing on developing and implementing a robust logistics strategy and well-controlled operations. The position is based at Vertex’s corporate headquarters in Boston, MA.

Key Responsibilities:

• Define a comprehensive global logistics strategy for a set of diverse pipeline and commercial programs in alignment with Vertex’s corporate strategy.  This strategy includes defining a robust logistics network of global providers to enable successful commercialization.  It also includes a 3-5+ year forward looking assessment of commercial forecast scenarios and associated materials movements to define logistics network expansion and systems requirements.  The role will establish long range optimization strategies to scale and deliver an integrated, best-in-class logistics.    
• Deliver reliable logistics operations, managing thousands of global shipments annually. This operation includes complex and diverse shipments from raw materials through finished goods for small molecules and short lead time, cold chain shipments for cell and gene therapy programs. The operation must deliver reliably for customers with problems being anticipated and mitigated before causing disruption.
• Responsible for defining and tracking global logistics budget.   The Executive Director will partner with Finance to establish the annual logistics budget based on prior year performance and forward-looking forecast.  Once established, the role is accountable for performance within budget and will identify opportunities for cost savings across the logistics network.
• Responsible for proactively assessing risk across logistics operation and developing business continuity plans.   The risk assessment includes couriers, warehouses and lanes for raw materials though finished goods. Risk mitigation and business continuity plans will be delivered to ensure timely, compliant delivery of materials across the supply chain.
• Deliver an integrated inspection readiness and logistics launch plan for Vertex’s Cell and Gene therapy and small molecule programs. The inspection readiness and launch plans include cold chain validation, lane identification, couriers, service level agreements and customer support models. The role will interact with multiple contract manufacturers, warehouses and couriers to train, onboard and successfully launch. The role will also include integration of systems requirements and complicated short-lead time cold chain logistics.  The Executive Director is responsible for leading the team through inspection and launch readiness, including making risk-based decisions to enable program success.
• Drive excellence in end-to-end operations through identification and management of key supply chain KPI’s.  Establish service level agreements and KPI’s throughout network.  Monitor KPI’s, deviation rates and performance across a complex network of providers. Drive operational efficiency, flawless execution and continuous improvement across the supply chain to deliver a best-in-class logistics organization. 
• Build a high performing team including forward looking organizational design requirements to scale to meet Vertex’s future vision.   Foster team culture, build trust and establish clear roles and responsibilities.
• Maintain an external network to stay updated on industry trends, emerging technologies and best practices in logistics.
• Champion the culture of quality and ensure that all activities and documentation comply with global regulatory requirements. Understand and implement processes and controls that align with GDP, evolving Health Authority, import/export and other regulatory expectations.  

Minimal Requirements:

• 12-15+ years progressive experience in supply chain, logistics and/or manufacturing leadership roles in the pharmaceutical industry. Experience with Biological products and Genetic and Cell Therapy technologies is strongly preferred.
• Experience in building and managing a complex global supply chain logistics operation.
• The candidate is expected to be a thought leader in logistics and supply chain and have a proven ability to innovate and implement practical, compliant solutions.
• A proven ability to work seamlessly across teams and develop excellent partnerships with peers.
• Demonstrated understanding of the principles and regulations associated with GDP operations.
• A results-oriented leader with a sense of urgency to deliver quality results in a highly ethical and professional manner.
• Motivational leadership of a cohesive high-performing team within a global, matrixed environment; the ability to articulate vision and successfully drive execution.
• Excellent communication and interpersonal skills with the ability to communicate complex issues and solutions enterprise-wide.
• Excellent team player who is able to build and sustain respect and trust at all levels of the organization.
• Ability to anticipate adverse scenarios and provide contingency plans to address them.
• Sound judgment and business acumen with personal versatility and flexibility as the business and team evolves.

Company Information

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Global Safety Head, Rare Disease

Live

What you will do

Let’s do this. Let’s change the world. In this vital role as the Executive Director, Global Safety Head, you will serve as the safety expert for Amgen’s rare disease products globally and are accountable for the safety strategy and major safety deliverables for each product. You will lead the rare disease safety teams and are accountable for the staff management and resource planning/allocation. You will serve as a core member of Global Product Safety Leadership team and will support the Global Product Safety (GPS) Vice President (VP) in the establishment of a highly effective global safety organization in full compliance with worldwide regulations.  This role reports into the Head of Global Patient Safety. 

Responsibilities:

• Serve as Safety expert in Rare Disease

• Accountable for providing strategic oversight and direction for all regulatory safety responses or strategic deliverables, including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs

• Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and ensures Therapeutic Area (TA) staff provides ongoing monitoring of safety profiles for Amgen products worldwide

• Chairs and participates in safety governance meetings per Standard Operating Procedures and Manuals

• Oversee Rare Disease Safety input to contractual agreements with Business Partners and CROs

• Works cross-functionally with Development and Regulatory TA Heads to reach issue resolution

• Provide safety oversight, strategy and guidance to therapeutic areas and other groups within Clinical Development, Medical Affairs, Regulatory and the commercial organizations

• Management of the Rare Disease safety teams providing direction and allowing appropriate prioritization of resources to achieve goals

• Recruit and retain talented safety professionals and provide coaching, mentoring, and development of staff

• Ensure staff are compliant with Amgen corporate and departmental training

• Contribute to Global Patient Safety goals in development

• Participate in budget and headcount planning

• Leads or sponsors significant cross-functional projects, initiatives or training

• Inspection Readiness

• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Basic Qualifications:

• MD or DO degree from an accredited medical school AND

• Five (5) years of industry or academic research AND  

• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• PhD with 15 years of directly related experience

• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

• Previous product safety experience and knowledge of clinical trials and drug development

• Knowledge of Rare Disease patient populations and drug classes

• Proven history of effective leadership with a matrix organization

• Issue and crisis management

• Strategic leadership ability and capable to manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects

• Understanding of international drug safety regulations, global pharmacovigilance and product safety processes

• Knowledge of general medicine, clinical care, and principles of epidemiology

• Influencing skills with capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels

• Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives

• Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting

• Identifying diverse, qualified successors for key positions

• Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $317,452 - $360,254.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgen’s Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range