Overview

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.

Director, Medical Affairs is an expert at the intersection of healthcare, physician-patient interactions, and clinical trials as an experienced investigator. This individual works in a pivotal role to develop and maintain a successful operating framework (Lightship Site)  for clinical research investigators to conduct Direct-to-Patient (DtP) clinical trials, while adhering to medical and Medicines & Healthcare products Regulatory Agency (MHRA) regulations, and Good Clinical Practice (GCP) guidelines. Additionally, the Director, Medical Affiars will work in collaboration with Clinical Operations to identify, recruit, contract and oversee Lightship’s clinical investigators to ensure that they possess the required clinical trial and medical specialty experience. This role also collaborates cross-functionally with other business units at Lightship to deliver successful clinical trials and to participate in client engagement.

The successful candidate with be entrepreneurial and must have the ability to build the Lightship Site within the US, work independently and as an effective and engaged team member in a fast-paced and innovative environment.

This position is part-time and remote, and a successful candidate will possess a willingness and desire to work independently without significant oversight.

We would like to offer you:

  • An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
  • The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade direct-to-patient clinical research solutions at scale
  • An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
  • Competitive compensation

Director, Medical Affairs is responsible for:

  • Participating in meetings with clients, vendors, and regulatory bodies; developing supporting materials for the meetings
  • Developing and maintaining a regulated clinical site – CQC
  • Developing and maintaining a DtP investigator operating framework for Lightship’s trials
  • Developing and implementing of an investigator recruitment strategy; overseeing ongoing investigator engagement
  • Contributing to designing the Lightship patient experience for trials
  • Contributing to assessing trials for feasibility in the DtP model
  • Helping to establish training program for investigators and study staff
  • Supporting audits and inspections as required
  • Other duties as required

Director, Medical Affairs has:

           Required knowledge, skills, and abilities

  • Experience in the practice of medicine and patient care
  • Knowledge of the healthcare system and patient visit flow
  • Experience practicing telemedicine and home health
  • Experience engaging with biopharma and the FDA
  • Working knowledge of GCP, FDA, and US medical requirements and their application to conduct compliant clinical trials
  • Ability to work in a dynamic, fast-paced environment
  • Ability to critically review protocols and provide comprehensive analysis of components required to conduct the trial
  • Strong interpersonal skills 

           Education and experience

  • 10+ years of experience in clinical trials conduct, clinical care, and/or medical care, or requisite combination of education, training, and experience
  • Doctor of Medicine (M.D.) degree, required
  • GMC Registered
  • Management experience
  • Ability to establish and tactically execute strategic vision
  • Ability to establish and maintain strong professional relationships
  • Strong written and verbal communication abilities
  • Attention to detail

Our commitment to diversity & inclusion:

Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.  EEO is the Law

Lightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster

Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.

#jobs #careers #nowhiring #hiringnow 

 

Apply for this Job

* Required
  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Lightship are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.