Clinical Development Medical Director-Nephrology

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 240,000 - 360,000; Full time

Job summary

Vertex Pharmaceuticals Inc (US) seeks a Clinical Development Medical Director to lead medical strategy across trials and to monitor subject safety as Medical Monitor. The role spans multiple trials in all Phases, with collaboration across Regulatory Affairs, Clinical Operations and other internal groups.

Ideal candidates hold an MD/DO, board certification in a specialty, and 10+ years in research or clinical development, including statistical methods, GCP and regulatory submissions.

Qualifications

• MD/DO or equivalent medical degree; board certification or eligibility in a specialty is highly desired.
• Experience leading medical strategy and monitoring in clinical trials.
• Strong data interpretation, scientific writing and regulatory submission experience.

Responsibilities

• Leads medical strategy and acts as Medical Lead for Vertex clinical trials.
• Oversees safety monitoring as Medical Monitor for enrolled subjects.
• Collaborates with cross-functional study teams on trial design and execution.
• Contributes to regulatory documents and study reports for submissions.
• Represents Vertex with external medical personnel and regulators.

Skills

Communication skills

Collaboration

GCP knowledge

Biostatistics knowledge

Regulatory submissions experience

Medical Monitor experience

Education

MD/DO or equivalent ex-US medical degree

Board certification/eligibility in a specialty field

Job description

Job Description General Summary

The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.

Key Duties and Responsibilities

• Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
• Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
• Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
• Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
• Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies
• Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
• Performs other duties as assigned related to clinical programs

Knowledge and Skills

Excellent oral and written communication skills Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate Effective at building alliances across functions, based on end-to-end drug development thinking and experience Board certification/eligibility in a medical, pediatric or surgical subspecialty

Education and Experience

MD, DO or equivalent ex-US medical degree Board certification/eligibility in a specialty field is highly desired Typically requires 10 years of basic or clinical research experience in an academic or industrial setting, or the equivalent combination of education and experience Typically requires experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design Typically requires experience with design, execution, and analysis of clinical trials required

Pay Range

Pay Range: $240,000 - $360,000 Disclosure Statement: 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.

Flex Designation

Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Help Us Achieve Our Mission

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work.

The diversity of our people is central to that culture.

By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible.

We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.

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 [e-mail]