Vertex Pharmaceuticals
Clinical Development Medical Director (Heme)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
Vertex Pharmaceuticals is seeking an experienced Medical Director to lead strategic and tactical activities for a broad range of ongoing clinical development activities within the Hematology clinical development team. You will work as part of multidisciplinary cross-functional teams on clinical development strategy, clinical trial data analysis and publications, data generation activities, ongoing clinical trial execution, and contributions to global regulatory submissions. You may also participate in pipeline development activities in the Hemoglobinopathies program, depending on background and interest. Key Responsibilities
Serve as the clinical development lead for hematology clinical development strategy and overall clinical development plans. Lead analysis of clinical trial data in context of strategic internal and external needs, including publication strategy and publication plan execution and related external communications. Lead data generation activities such as real-world evidence studies, post-approval studies, and health outcomes studies. Provide clinical and scientific subject matter expertise for global regulatory activities and documents including post-approval information requests, labeling, and data submissions (e.g., study reports and summary documents). Contribute subject matter input for in-scope pipeline development activities (e.g., preclinical programs or external innovation/business development). Act as liaison between Clinical Development and other internal groups for hematology program-related working groups. Represent Vertex/VCGT to external medical personnel for clinical development activities, including supporting medical monitors of ongoing trials, advisory boards, and data presentations. Knowledge And Skills
Ability to work collaboratively in a fast-paced, matrixed environment and function independently as appropriate. Apply novel and creative methods to independently resolve clinical development problems. Working knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and execution. Experience in analysis of research data and publications. Excellent verbal and written communication skills. A desire to be part of a highly innovative company aiming to transform the lives of people with serious diseases and their families. Education And Experience
MD, MD/PhD, DO or international equivalent. Board certification/eligibility in internal or pediatric medicine or another relevant medical field is highly desired; clinical development/experience in hematology and/or oncology (including hematopoietic stem cell transplant medicine) is a plus. Approximately 10 years of basic or clinical research experience in an academic or industry setting, or equivalent with cross-functional teams. Experience in analysis of research data and publications with working knowledge of biostatistics. Working knowledge of GCP including medical monitoring; experience with scientific/clinical research methods and trial design and execution. Ability to travel up to 15% to support program activities as needed. Compensation And Benefits
Pay Range:
$237,200 - $355,700 Disclosure:
The base salary range is a reasonable estimate at posting. Role may be eligible for annual bonus and equity awards. Overtime pay may apply where required by law. Actual salary based on skills, experience, and other factors. Vertex Total Rewards include comprehensive benefits, time off, education assistance, retirement plans, and additional programs. Flex Designation
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status
In this Hybrid-Eligible role, you can be: Hybrid: work remotely up to two days per week On-Site: five days per week on-site with ad hoc flexibility Note: Flex status is subject to Vertex policies and may change. Equal Opportunity
Vertex is an equal employment opportunity and non-discrimination employer. Vertex is an E-Verify Employer in the United States. Reasonable accommodations will be provided for qualified individuals with known disabilities as required by law. Applicants may request accommodations by contacting the recruiter or Talent Acquisition at ApplicationAssistance@vrtx.com.
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Vertex Pharmaceuticals is seeking an experienced Medical Director to lead strategic and tactical activities for a broad range of ongoing clinical development activities within the Hematology clinical development team. You will work as part of multidisciplinary cross-functional teams on clinical development strategy, clinical trial data analysis and publications, data generation activities, ongoing clinical trial execution, and contributions to global regulatory submissions. You may also participate in pipeline development activities in the Hemoglobinopathies program, depending on background and interest. Key Responsibilities
Serve as the clinical development lead for hematology clinical development strategy and overall clinical development plans. Lead analysis of clinical trial data in context of strategic internal and external needs, including publication strategy and publication plan execution and related external communications. Lead data generation activities such as real-world evidence studies, post-approval studies, and health outcomes studies. Provide clinical and scientific subject matter expertise for global regulatory activities and documents including post-approval information requests, labeling, and data submissions (e.g., study reports and summary documents). Contribute subject matter input for in-scope pipeline development activities (e.g., preclinical programs or external innovation/business development). Act as liaison between Clinical Development and other internal groups for hematology program-related working groups. Represent Vertex/VCGT to external medical personnel for clinical development activities, including supporting medical monitors of ongoing trials, advisory boards, and data presentations. Knowledge And Skills
Ability to work collaboratively in a fast-paced, matrixed environment and function independently as appropriate. Apply novel and creative methods to independently resolve clinical development problems. Working knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and execution. Experience in analysis of research data and publications. Excellent verbal and written communication skills. A desire to be part of a highly innovative company aiming to transform the lives of people with serious diseases and their families. Education And Experience
MD, MD/PhD, DO or international equivalent. Board certification/eligibility in internal or pediatric medicine or another relevant medical field is highly desired; clinical development/experience in hematology and/or oncology (including hematopoietic stem cell transplant medicine) is a plus. Approximately 10 years of basic or clinical research experience in an academic or industry setting, or equivalent with cross-functional teams. Experience in analysis of research data and publications with working knowledge of biostatistics. Working knowledge of GCP including medical monitoring; experience with scientific/clinical research methods and trial design and execution. Ability to travel up to 15% to support program activities as needed. Compensation And Benefits
Pay Range:
$237,200 - $355,700 Disclosure:
The base salary range is a reasonable estimate at posting. Role may be eligible for annual bonus and equity awards. Overtime pay may apply where required by law. Actual salary based on skills, experience, and other factors. Vertex Total Rewards include comprehensive benefits, time off, education assistance, retirement plans, and additional programs. Flex Designation
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status
In this Hybrid-Eligible role, you can be: Hybrid: work remotely up to two days per week On-Site: five days per week on-site with ad hoc flexibility Note: Flex status is subject to Vertex policies and may change. Equal Opportunity
Vertex is an equal employment opportunity and non-discrimination employer. Vertex is an E-Verify Employer in the United States. Reasonable accommodations will be provided for qualified individuals with known disabilities as required by law. Applicants may request accommodations by contacting the recruiter or Talent Acquisition at ApplicationAssistance@vrtx.com.
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