Total 8 Project Director job vacancies in Health / Beauty / Fitness category in The United States of America

Job Description

The Publications Associate Director is a key contributor and cross-functional, collaborative partner supporting Vertex's ever-expanding pipeline and portfolio of innovative and life-changing therapies.

In this position, you will be responsible for the development of medical, scientific, and technical publications. This role will provide expertise and leadership in the planning and execution of key publication deliverables for one or more disease areas.

Key Duties and Responsibilities:

• Lead the drafting/development of key abstracts, posters, congress presentations, and manuscripts
• Coordinate with cross-functional teams and key stakeholders to achieve publication objectives
• Manage publication development timelines and content development associated with abstracts, posters, oral presentations, and manuscripts
• Responsible for the execution of the global publication plan for one or more brands
• Provide regular updates on project status using trackers and through cross-functional publication team meetings
• Ensures compliance with Vertex publication policy and external publication guidelines
• Acts as a coach to mentor members of the team

Knowledge and Skills:

• Excellent scientific writing skills, including the ability to interpret and summarize data in a clear and concise fashion
• Strong organizational skills with ability to prioritize multiple projects and/or vendors to meet deadlines  
• Ability to work independently and collaboratively with multiple internal functions and external stakeholders in a highly matrixed environment composed of cross-functional, dynamic teams
• Clear understanding of current publication environment, ICMJE, GPP3, and other global guidelines related to publications, scientific data communication, and transparency standards
• Strong computer and database skills, particularly with Microsoft Office products and Datavision
• Experience in publication planning and execution

Education and Experience:

• PhD
• Typically requires 8 years of experience in publications and medical writing

Pay Range 154,080.00 – 231,120.00 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility   and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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Company Information

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

Job Description

We are seeking a highly experienced and dedicated Sr. Medical Director to lead our US-centric Medical Affairs team in the Pain therapeutic area. As a key member of our organization, you will have the opportunity to make a significant impact on improving patient outcomes through your expertise and strategic leadership.

As the Sr. Medical Director, you will be driving development and execution of the US Pain Medical Strategy. Your knowledge, expertise, communication skills, experience with the US healthcare system and your ability to build strong relationships with various external stakeholders including key thought leaders relevant to the management of pain will be instrumental in effectively representing Vertex, our science and our commitment to improving patient outcomes.

Internally, you will collaborate closely with the global medical affairs team, development and project teams, as well as our commercial, HEOR and development teams, to align with disease and brand priorities. You will play a key role in identifying and filling key data gaps to optimize clinical practice and patient outcomes.

Key Responsibilities:

- Develop US-centric medical affairs plans, including launch and Life Cycle Management plans.
- Interpret scientific data and determine the potential impact on medical thinking and practice, ensuring appropriate care and long-term health outcomes for patients in the US.
- Lead thought leader engagement initiatives, building strong relationships with key opinion leaders in the Pain therapeutic area.
- Serve as a representative of Vertex, actively engaging with external stakeholders such as thought leaders, patient advocacy groups, and medical conferences.
- Collaborate with the development team on late-phase clinical development trials in the US.
- Incorporate insights and needs into US and global strategies

- Serve as the Medical Affairs representative in various cross-functional working group

- Partner with stakeholders to design and deliver Phase IIIB/IV studies to support reimbursement and access needs in the US.
- Provide medical support for the preparation of US-specific reimbursement dossiers.
- Establish strong relationships and scientific communication with External Experts and Patient Advocacy groups in the US Pain therapeutic area.
- Represent Vertex at key external meetings and medical conferences.
- Participate in grant committee meetings and support Investigator Initiated Studies (IIS) review for Pain in the US.
- Conduct medical/scientific training for US-based Commercial and other internal stakeholders.
- Provide medical intelligence and support at relevant medical congresses
- Ensure compliance with US laws, regulations, and codes.

Skills and Experience:

- MD degree, with a specialty in an area that manages acute and/or chronic pain.
- 8+ years of experience in the biotechnology or pharmaceutical industry, with at least 5 years in US-focused Medical Affairs.
- Strong communication skills, with the ability to effectively present complex medical information
- Excellent relationship-forming capabilities and the ability to work in a matrix environment.
- Team-oriented with strong interpersonal skills and the ability to collaborate effectively.
- Creative thinker with the ability to see the big picture while focusing on specific tactical needs in the US healthcare environment
- Strong negotiation and persuasion skills, able to hold positions and ideas without alienating others.
- Ability to work in tight timelines and willingness to travel up to 40% of the time

Pain touches so many of us. Apply now to make a difference in the lives of patients and represent Vertex's commitment to advancing science and healthcare.

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Company Information

Job Description

The Medical Director, Global Strategy, will provide medical support for the Cystic Fibrosis (CF) therapeutic area, participating in development and execution of the of the medical strategy and plan. He/she will partner with the Executive Medical Director, Global Strategy, to deliver Global Medical Affairs activities for CF and will work closely with a cross-functional group that includes Clinical Development, North American and International Medical Affairs, HEOR/Market Access, Marketing, Regulatory, and Medical and Corporate Communications to ensure that scientific and medical strategies are aligned with broader corporate and patient needs. This person must have the ability to work effectively in a highly matrixed environment and have a successful track record of developing project strategies and translating and executing tactics. He/she is expected to have a strong commitment to achieving corporate and medical objectives while maintaining the highest ethical, regulatory and scientific standards

Key Responsibilities

• Responsible for strategic alignment of the assigned clinical program, working cross functionally and partnering with other key functions as outlined

• Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and annual brand tactical plans

• Support development of Life Cycle Management Plans, Study Protocols and other key study documents in conjunction with other line functions and with limited guidance

• Align Global Medical Affairs objectives with those of Clinical Development and Commercial operations to ensure programs meet the needs of all stakeholders. 

• Serve on cross-functional study execution teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution and to function as medical lead and medical monitor for global phase 3b/4 clinical trials.

• Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate

• Responsible for alignment on and communication of medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and/or marketed compounds

• Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), and clinical study reports (CSR) as appropriate

• Work with the Global Communications team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts.

• Serve as promotional reviewer for global commercial pieces.

• Partner with global thought leaders to provide insights on current focused therapeutic area issues and questions

• Partner with external registries on non-interventional studies using secondary data, as appropriate.

• Review investigator-initiated proposals and other research grants, as appropriate.

• Provide medical input and guidance to Early Access Programs and individual IND (early access) requests.

Minimum Qualifications 

• Medical Degree (MD or DO) with board certification in relevant specialty

• 10 years of experience or the equivalent combination of education and experience following terminal degree

• At least 3 years of experience in a biopharma role, with experience in analysis of research (pre-clinical and clinical) data and publications; working knowledge of GCP, biostatistics as well as scientific and clinical research methods, and clinical study design

• Strong knowledge of internal medicine, pediatrics, pulmonary medicine and/or other relevant specialty. Experience in orphan diseases is a plus.

• Experience in Medical Affairs within the biotechnology or pharmaceutical industry is a significant plus

• Good understanding of global Medical, Regulatory and Commercial environments

• Possess understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.

• Excellent strategic skills with the ability to influence decisions, both internally and externally

• Excellent written and oral communication skills; high-level negotiation skills

• Ability to work and adapt in a fast-pace and evolving environment, as well as the proven track record of working effectively in diverse multi-cultural teams involving multi-functional disciplines

• Ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts

• Possess the ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner 

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Job Description

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. This role will assist Global Patient Safety (GPS) Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Directly and/or via oversight of direct reports, the role will lead 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 the program specific Clinical Teams, Medical Affairs, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.

Key Duties and Responsibilities:

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for DSTs.

• Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices.

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

• Collaborates with NDA teams in support of submissions, specifically leading development of any SCS, CLO, Label and Risk Management Plan (RMP) or equivalent documents.

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

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.

• Provides review and safety-specific input for labeling documents.

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

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

• Conducts medical evaluation of relevant safety information from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, 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 Study Reports.

• Provides contributory to Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental activities, SOP development.

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

Knowledge and Skills:

• Broad and comprehensive knowledge of General Medicine

• Extensive knowledge of GCP, ICH and Global regulations

• 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 coherent messaging

• Comprehensive knowledge of Benefit-Risk strategies and decision-making

• Ability to multi-task, adeptly handling multiple demands

Education and Experience:

• Doctorate in Medicine (M.D.) required

• 7+ years of work experience with some experience in Pharmacovigilance and 5 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Job Description

Vertex Pharmaceuticals is seeking a Health Economics & Outcomes Research (HEOR) Associate Director - pain to join the North America HEOR team.  This role will support and develop key HEOR tactics to ensure successful commercialization of novel NaV 1.8 inhibitors for acute and chronic pain in the United States (US) and Canada. This person will work in a highly cross-functional matrix team environment to ensure a seamless alignment of HEOR projects within the broader market access, policy, and medical strategy.  This person is expected to exhibit a strong sense of urgency to achieve corporate objectives while maintaining the highest ethical, regulatory and scientific standards.  This position reports to the Director, Pain launch lead, North America HEOR.

Key Responsibilities

• Own development of tactics for innovative HEOR solutions and deliverables that directly support optimal patient access to in the US and Canada throughout the product’s lifecycle  
• Drive the development of external customer-facing value demonstration tools in accordance with regulatory standards, in close collaboration with formal review bodies (e.g., Commercial Review Committee; Medical Review Committee) while supporting appropriate field teams (e.g., field HEOR, payer team)
• Work closely with global HEOR team to provide the US and Canadian perspective to evidence generation activities and to ensure timely and effective translation of HEOR studies for field use
• Directly engage with external customers (e.g., payer accounts) to deliver HEOR presentations when appropriate/requested
• Own execution of local HEOR studies in partnership with customers (e.g., payers, integrated health systems)

Qualifications

• Advanced degree (e.g. PhD, MD, MPH, or PharmD) in a scientific discipline.  
• Typically requires 8+ years of experience, with substantial background in HEOR, or the equivalent combination of education and experience. US launch experience in pain and/or other primary market experience is preferred.
• Robust understanding of the 2018 FDA Payor Guidance to payer communication in the US is strongly preferred.
• Understanding of the HTA process and methodology; hands-on experience with HTA dossier submission and review is preferred.
• A track record of peer-reviewed publications demonstrating experience in COAs, observational research, and/or health economic modeling.
• Strong communication skills, both verbal and written, including the ability to effectively present to both internal and external audiences
• Results oriented and excellent analytic and project management skills. 
• A strong sense of urgency and commitment to patients

This is a hybrid eligible role requiring at least 3 days on-site in Boston office.

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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

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