Clinical Development, Medical Director - Boston, United States - Vertex Pharmaceuticals, Inc

Vertex Pharmaceuticals, Inc Boston, United States

1 week ago

Description

Job Description

General Summary:

The Clinical Development Medical Director will serve as the Surgical Lead for clinical trials, working with cross-functional teams on Surgical and 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 surgical lead accountable for subject surgery, 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 Surgical manual, 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., Research, 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
General surgery experience required, experience in trauma/abdominal wall surgery is a plus
8 years of basic or clinical research experience in an academic and/or industry setting

Travel: 30% Domestic and International

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid:

work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

#LI-BS1

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

Medical Director

5 days ago

The Medicus Firm Boston, United States Full time

Non-Profit in Boston, MA · Full-time, Medical Director · Exponential company growth has created a need for an additional Medical Director · Outpatient Only - 5+ years of Medical Director Experience · Quality of Care/Quality of Life Position · Incredible4-day work weekfocused o ...
Medical Director

4 days ago

Hays Recruitment Boston, United States

Hays Investor · Work for Hays · About Us · Find Us · US EN · For Job Seekers · For Organizations · Australia · Austria · Belgium · Brazil · Canada · Chile · China · Colombia · Czech Republic · Denmark · France · Germany · Hong Kong SAR · Hungary · Italy · Ja ...
Medical Director

12 hours ago

Olema Oncology Boston, United States

Who We Are >>> Why You Should Work With UsOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, ...
Medical Director

2 weeks ago

Hays Recruitment Boston, United States

Hays InvestorWork for HaysAbout UsFind UsUS EN For Job SeekersFor OrganizationsAustraliaAustriaBelgiumBrazilCanadaChileChinaColombiaCzech RepublicDenmarkFranceGermanyHong Kong SARHungaryItalyJapanLuxembourgMalaysiaMexicoNetherlandsNew ZealandPolandPortugalRomaniaSingaporeSpainSwe ...
Director, Medical Affairs

1 week ago

Verve Therapeutics Inc Boston, United States

The Position · The Director of medical affairs will be responsible for contributing to the overall medical affairs strategy and executing tactical plans. Priority activities include publications and medical communications, scientific congress execution, internal training material ...
Executive Medical Director

6 days ago

RBW Consulting Boston, United States

A clinical stage precision oncology business in Boston, MA requires an Executive Medical Director lead a team of Medical Directors in the advancement of therapies for solid tumors based on their proprietary CRISPR-based platform. · Responsibilities: · Establish clinical developme ...
Medical Director, GDS

1 week ago

Alexion Pharmaceuticals, Inc. Boston, United States

This is what you will do: · The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's produ ...
Psychiatric Medical Director

1 day ago

Casa Esperanza, Inc. (Boston) Boston, United States

Company Description · Casa Esperanza, Inc. is a bilingual and bi-cultural human services organization located in Roxbury, MA. We specialize in serving the Latino community in Massachusetts and our mission is to empower individuals and families to recover from substance use disord ...
Psychiatric Medical Director

2 weeks ago

Casa Esperanza, Inc. (Boston) Boston, United States

Company Description · Casa Esperanza, Inc. is a bilingual and bi-cultural human services organization located in Roxbury, MA. We specialize in serving the Latino community in Massachusetts and our mission is to empower individuals and families to recover from substance use disord ...
Medical Affairs Director

6 days ago

Ironwood Pharmaceuticals, Inc. Boston, United States

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
Senior Medical Director

1 week ago

AstraZeneca PLC Boston, United States

Location · US: Boston or Gaithersburg, MD · Spain: Barcelona · Sweden: Gothenburg · Are you an experienced drug developer with expertise in immunology, rheumatology or inflammatory bowel disease? Would you like to be a part of a talented and high performing team of clinical resea ...
Medical Director, GDS

4 days ago

AstraZeneca Boston, United States

This is what you will do: · The Medical Director, Global Patient Safety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's produc ...
Global Development Associate Medical Director or Medical Director

6 days ago

AstraZeneca PLC Boston, United States

Job Title: Global Development Associate Medical Director / Medical Director (Physician) Late R&I · Location: Office based with flexibility in Boston Seaport, MA · Follow the science to explore and innovate · Here we are committed to making a difference. We have built our business ...
Medical Affairs Medical Director, Pain

1 week ago

Vertex Pharmaceuticals, Inc Boston, United States

Job Description · The Medical Affairs Medical Director will provide medical leadership for the Medical Department in the Pain therapeutic area. This role will be accountable for working with the medical team for North America, for the development and implementation of the North A ...
Veterinary Medical Director

4 days ago

Desort Boston, United States

Full time Veterinary Medical Director - Amazing Opportunity - Boston, MA · We are looking for a full-time Veterinary Medical Director to join our team in Boston, MA. The ideal candidate will have a DVM or equivalent degree, and experience as a Veterinarian or Associate Veterinar ...
Assistant Medical Director

2 days ago

Massachusetts Bay Transportation Authority (MBTA) Boston, United States

At the MBTA, we envision a thriving region enabled by a best-in-class transit system. Our mission is to serve the public by providing safe, reliable, and accessible transportation. MBTAs core values are built around safety, service, equity, and sustainability and each employee th ...
Director of Medical Affairs

4 days ago

Empatica Boston, United States

Empatica · Empatica is a full-stack digital healthcare company and a pioneer in digital biomarker development and continuous patient monitoring driven by AI. Our platform consists of medical-grade smartwatches, software, and physiological and behavioral digital biomarkers. Toget ...
Medical Affairs Director

1 week ago

Ironwood Pharmaceuticals Boston, United States

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
Executive Medical Director, Medical Affairs-Hematology

1 week ago

Vertex Pharmaceuticals, Inc Boston, United States

Job Description · The Executive Medical Director, Medical Affairs Hematology will provide medical leadership in the Medical Affairs function for our Hematology therapeutic area. This role will be accountable for leading and overseeing the US medical team for the development and i ...
Medical Director, Care at Home

6 days ago

Best Buy Boston, United States

As the Medical Director, Care at Home you will draw on your experience caring for patients with chronic disease in a hospital and/or ambulatory setting to define best practices for the care of these patients outside of the hospital. You can speak to Medical Director, Director, Me ...