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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
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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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
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Official account of Jobstore.
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
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Enterprise Health Team Sales Executive- (South Region)
Do you enjoy being part of an industry-leading team?
At Alight, we believe a company’s success starts with its people. At our core, we Champion People, help our colleagues Grow with Purpose and true to our name we encourage colleagues to “Be Alight.”
Our Values
Champion People – be empathetic and help create a place where everyone belongs.
Grow with purpose – Be inspired by our higher calling of improving lives.
Be Alight – act with integrity, be real and empower others.
It’s why we’re so driven to connect passion with purpose. Our team’s expertise in human insights and cloud technology gives companies and employees around the world the ability to power confident decisions, for life.
With a comprehensive total rewards package, continuing education and training, and tremendous potential with a growing global organization, Alight is the perfect place to put your passion to work.
Join our team if you Champion People, want to Grow with Purpose through acting with integrity and if you embody the meaning of Be Alight.
Learn more at careers.alight.com.
The South region Sales Executive role, sought by the Enterprise Health Team, aims to boost revenue. It requires building customer relationships, implementing sales strategies and ensuring client satisfaction.
Responsibilities
Requirements
Flexible Working
So that you can be your best at work and home, we consider flexible working arrangements wherever possible. Alight has been a leader in the flexible workspace and “Top 100 Company for Remote Jobs” 5 years in a row.
Benefits
We offer programs and plans for a healthy mind, body, wallet and life because it’s important our benefits care for the whole person. Options include a variety of health coverage options, wellbeing and support programs, retirement, vacation and sick leave, maternity, paternity & adoption leave, continuing education and training as well as a number of voluntary benefit options.
By applying for a position with Alight, you understand that, should you be made an offer, it will be contingent on your undergoing and successfully completing a background check consistent with Alight’s employment policies. Background checks may include some or all the following based on the nature of the position: SSN/SIN validation, education verification, employment verification, and criminal check, search against global sanctions and government watch lists, credit check, and/or drug test. You will be notified during the hiring process which checks are required by the position.
Our commitment to Diversity and Inclusion
Alight is committed to diversity, equity, and inclusion. We celebrate differences and believe in fostering an environment where everyone feels valued, respected, and supported. We know that diverse teams are stronger, more innovative, and more successful.
At Alight, we welcome and embrace all individuals, regardless of their background, and are dedicated to creating a culture that enables every employee to thrive. Join us in building a brighter, more inclusive future.
Diversity Policy Statement
Alight is an Equal Employment Opportunity employer and does not discriminate against anyone based on sex, race, color, religion, creed, national origin, ancestry, age, physical or mental disability, medical condition, pregnancy, marital or domestic partner status, citizenship, military or veteran status, sexual orientation, gender, gender identity or expression, genetic information, or any other legally protected characteristics or conduct covered by federal, state or local law. In addition, we take affirmative action to employ and advance in the employment of qualified minorities, women, disabled persons, disabled veterans and other covered veterans.
Alight provides reasonable accommodations to the known limitations of otherwise qualified employees and applicants for employment with disabilities and sincerely held religious beliefs, practices and observances, unless doing so would result in undue hardship. Applicants for employment may request a reasonable accommodation/modification by contacting his/her recruiter.
Authorization to work in the Employing Country
Applicants for employment in the country in which they are applying (Employing Country) must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the Employing Country and with Alight.
Note, this job description does not restrict management's right to assign or reassign duties and responsibilities of this job to other entities; including but not limited to subsidiaries, partners, or purchasers of Alight business units.
We offer you a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
DISCLAIMER:
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job to other entities; including but not limited to subsidiaries, partners, or purchasers of Alight business units.
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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 Medical Director, Global Development
Live
What you will do
Let’s do this. Let’s change the world. As an Executive Medical Director, you will play an important role in planning and execution for all aspects of clinical drug development across Amgen’s clinical programs.
This Executive Medical Director within Clinical Development will be involved with the full scope of the rare disease clinical drug development activities from discovery research through first in human, POC and Phase 3 or Phase 4 studies. They will serve as the principal representative for global development within the rare disease therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.
This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position must work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy. The Executive Medical Director will report into the Vice President, Clinical Development (Rare Diseases).
This position is currently located in the Deerfield, Illinois office, but alternative locations will be considered for the right candidate.
Responsibilities
Serve as the global development leader for a product team with an enterprise mindset
Manage clinical development medical and/or scientific directors working on various clinical trials for the product
Provide adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile
Provide adequate oversight in the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues
Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities
Review, interpret and present clinical data to internal and external stakeholders
Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents
Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations
Maintain up-to-date knowledge of scientific and clinical published literature
Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants
Provide input/review study start up documentations, e.g., CRF design
Attend and provide clinical support for investigator and steering committee meetings
Participate in due diligence and business development activities as needed
Always operate within Compliance Guidelines
Provide medical monitoring oversight for clinical trials as required
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Executive Medical 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 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
MD, PhD, MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent
Ten (10) or more years in biopharmaceutical sponsored clinical research is desirable
Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable
Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Ability to analyze and interpret complex datasets
Exercises initiative in meeting goals and drives innovation in projects
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we 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 $306,229 - $373,641.
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
306,229.00 USD - 373,641.00 USDOfficial account of Jobstore.
