Associate Medical Director, Endocrinology

Vertex Pharmaceuticals LLC

Boston (MA)

Hybrid

USD 204,000 - 306,000

Full time

46 hours ago
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Benefits offered by this job

Hybrid work arrangement

Job summary

Vertex Pharmaceuticals LLC in Boston seeks an Associate Medical Director in Endocrinology to lead medical oversight of pediatric and adult endocrinology trials. You will drive study strategy, safety monitoring, and data reporting, coordinating with Regulatory Affairs and Clinical Development Execution.

Ideal candidates hold an MD/DO (ex-US degrees accepted) with extensive clinical research experience, board eligibility, and a track record of collaboration across global teams.

Qualifications

  • Excellent verbal and written communication across global teams.
  • Experience in global clinical development and regulatory interactions.
  • Ability to design and interpret clinical studies and safety monitoring.

Responsibilities

  • Lead Medical oversight of clinical trials with cross-functional teams.
  • Serve as Medical Lead for study strategy, design, execution and reporting.
  • Monitor safety and ensure scientific integrity of trial data.
  • Represent Vertex to external medical personnel and regulators.

Skills

Strong communication
Cross-functional collaboration
Clinical development
Regulatory interaction
Biostatistics/ PK/PD

Education

MD/DO or equivalent ex-US degree

Job description

Associate Medical Director, Endocrinology### Associate Medical Director, EndocrinologyApply: Boston, MA: Full time: Posted Today: REQ-30476**Job Description**Vertex completed its acquisition of Crinetics Pharmaceuticals on September 1, adding commercial and pipeline endocrinology programs to Vertex’s innovation portfolio. The acquisition is expected to accelerate revenue growth and enhance the Company’s long-term earnings profile. The acquired portfolio includes PALSONIFY (paltusotine), atumelnant, and several additional pipeline programs. PALSONIFY is the first and only once-daily oral therapy for acromegaly; it has launched in the United States, is approved in the European Union, and is under review by other global regulatory authorities. Atumelnant is an investigational, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist in Phase 3 development for congenital adrenal hyperplasia (CAH) and Phase 2 development for Cushing’s syndrome. We are seeking a pediatric or adult endocrinologist to contribute clinical expertise to the development of atumelnant. **General Summary:**The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting. In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may participate in other projects to support the clinical development program. **Key Duties and Responsibilities:*** Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key 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 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* Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports* Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies* Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results* Performs other duties as assigned related to other aspects of Clinical Development **Knowledge and Skills:*** Strong oral and written communication skills* Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate* Global clinical research experience and experience interacting with regulatory authorities is a plus* Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development* Board certification/eligibility, as well as clinical training in a relevant medical specialty is highly desired **Education and Experience:*** MD, DO or equivalent ex-US medical degree* Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience**About Vertex**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. 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.**Pay Range:**$204,000 - $306,000**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.#LI-Hybrid**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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