director of clinical trials

Tigerlily Foundation

<p></p><div><div><div>The Director of Clinical Trial Access and Partnerships lead Tigerlily Foundation&rsquo;s work to expand equitable access to clinical trials as part of the breast cancer care journey. This role focuses on connecting women of color, young women, and other marginalized populations to accurate information, supportive resources, and opportunities to participate in trials when they choose.</div>
</div><div><h3 class="jobSectionHeader"><b>About The Tigerlily Foundation</b></h3>
<div><div>Tigerlily Foundation is a national foundation providing education, awareness, advocacy and hands-on support to young women&ndash;before, during and after cancer, as well as empowering women throughout their health journey. Through our programs, we seek to educate and empower women of all backgrounds, including those at heightened risk, those facing health disparities, and those with less access to care.
</div></div></div><div><h3 class="jobSectionHeader"><b>Description</b></h3><br>
<div></div><div><div><br>
<h1 class="jobSectionHeader"><b>APPLICATION DEADLINE: November 17, 2025</b></h1><div></div><div><b><br>
About Tigerlily Foundation</b></div><div>
Tigerlily Foundation is a national breast cancer organization dedicated to educating, advocating for, empowering, and supporting young women, especially women of color and other underserved populations, before, during, and after breast cancer. Through our programs, we strive to transform lives and systems by addressing disparities and creating equitable access to care, research, and clinical trials.</div><div></div><div><b><br>
Position Summary</b></div><div></div><div><br>
The <b>Director of Clinical Trial Access and Partnerships</b> lead Tigerlily Foundation&rsquo;s work to expand equitable access to <b>clinical trials</b> as part of the breast cancer care journey. This role focuses on connecting women of color, young women, and other marginalized populations to accurate information, supportive resources, and opportunities to participate in trials when they choose. The Director designs and implements national strategies that improve awareness, access, and representation, while ensuring all outreach and engagement activities are transparent, ethical, and compliant.</div><div>
This position also oversees the lifecycle of community-to-trial engagement, from education and identification through referral, tracking, and reporting. It ensures that data systems and communications meet HIPAA, IRB, and Good Clinical Practice standards, and that all activities uphold Tigerlily&rsquo;s commitment to health equity, inclusion, and cultural competence.</div><div>
Tigerlily Foundation does not conduct clinical trials, but partners with funders, CROs, research teams, and clinical sites to ensure that historically underrepresented patients are fully informed about clinical trials as an option in their care. The Director works closely with the <b>Director of Community Engagement and Clinical Trial Equity</b> to align education, outreach, and data-driven approaches that strengthen trust, transparency, and participation.</div><div></div><div><b><br>
Key Responsibilities</b></div><ul><li>
Design and lead national strategies that increase awareness and equitable access to clinical trials for underrepresented communities.</li><li>
Build and sustain partnerships with funders, CROs, research teams, and clinical sites to align access and engagement goals.</li><li>
Develop and manage compliant outreach and referral processes in collaboration with sponsors and research partners.</li><li>
Coordinate with Peer Navigators and outreach staff to ensure accurate study information, clear communication, and culturally responsive engagement.</li><li>
Oversee data management, reporting, and privacy compliance across all program activities, ensuring alignment with HIPAA, IRB, and Good Clinical Practice standards.</li><li>
Maintain and optimize CRM systems such as Monday.com to track outcomes and report metrics to funders and internal stakeholders.</li><li>
Contribute to grant proposals, renewals, and reports by providing validated data, access outcomes, and partnership impact.</li><li>
Develop accessible, culturally grounded educational materials to promote informed decision-making about clinical trials.</li></ul><div></div><div><b><br>
Qualifications</b></div><ul><li>
Minimum 7 years of experience in clinical research, patient navigation, public health, or health equity programs.</li><li>
Proven track record advancing <b>health equity and inclusion for marginalized communities</b>, particularly women of color and those facing barriers to care.</li><li>
Support <b>funder impact reports, grant deliverables, and renewal proposals</b> by providing validated data, access outcomes, and partnership impact.</li><li>
Strong understanding of HIPAA, IRB, and Good Clinical Practice standards.</li><li>
Demonstrated skill in <b>data management, reporting, and CRM system use</b> (experience with Monday.com preferred).</li><li>
Ability to analyze program data, prepare accurate reports, and use insights to drive strategy.</li><li>
Exceptional written and verbal communication skills with the ability to translate complex information clearly and build trust across diverse communities.</li><li>
Deep cultural competence and experience engaging underrepresented populations in healthcare or clinical research settings.</li><li>
Master&rsquo;s degree in public health, Clinical Research, or related field preferred; certification in human subjects protection (e.g., CITI) strongly desired.</li></ul></div></div></div></div><div></div>

Director of Clinical Trial Access and Partnerships

Summit Therapeutics, Inc.

<div>
 <strong>
  About Summit
  <br/>
  <br/>
 </strong>
 Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational
 <br/>
 <br/>
 bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
 <br/>
 <br/>
 Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
 <br/>
 <br/>
 <ul>
  <li>
   HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
  </li>
  <li>
   HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  </li>
  <li>
   HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
   <br/>
   <br/>
  </li>
 </ul>
 Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit&rsquo;s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food &amp; Drug Administration (FDA) for the HARMONi clinical trial setting.
 <br/>
 <br/>
 <strong>
  Overview Of Role
  <br/>
  <br/>
 </strong>
 The Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. The Director, Clinical Scientist will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.
 <br/>
 <br/>
 <strong>
  Role And Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
  </li>
  <li>
   Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
  </li>
  <li>
   Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
  </li>
  <li>
   Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
  </li>
  <li>
   Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
  </li>
  <li>
   Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
  </li>
  <li>
   Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
  </li>
  <li>
   Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  </li>
  <li>
   Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
  </li>
  <li>
   Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  </li>
  <li>
   Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
  </li>
  <li>
   All other duties as assigned
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Experience, Education And Specialized Knowledge And Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   MS (or equivalent) required,
  </li>
  <li>
   PhD, PharmD, or MD preferred
  </li>
  <li>
   5+ years overall related experience with PhD or like degree; Minimum of 2 years&rsquo; experience in conducting / supporting oncology/hematology clinical studies
  </li>
  <li>
   Excellent written and verbal communication skills
  </li>
  <li>
   Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
   <br/>
   <br/>
  </li>
 </ul>
 The pay range for this role is $186,000-$233,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
 <br/>
 <br/>
 Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit&rsquo;s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
</div>


Director, Clinical Scientist

Medtronic

<div><p>At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
</p><p></p><h1 class="jobSectionHeader"><b>A Day in the Life
</b></h1><p><b>Careers That Change Lives
</b></p><p>Join a mission-driven industry leader in medical technology and solutions to help drive innovation and transform the healthcare landscape. As <b>Clinical Research &amp; Medical Sciences Director </b>you will oversee both clinical and medical sciences aspects of running the medical organization in the TuRMECA region. Reporting to Chief Medical Officer Global Regions and VP Clinical Research &amp; Medical Sciences, you will lead the development and execution of clinical research and medical sciences agenda in TuRMECA region to enable patient access to innovative medical technologies.
</p><p></p><p><b>A Day in Life
</b></p><ul><li>Provides Clinical/Medical Leadership at Business Reviews and discussions with the respective Country Leaders in the TuRMECA region.
</li><li>As a Leader within the TuRMECA regional organization, contributes to the development of a Clinical &amp; Medical affairs strategy and execute them in their sub-region.
</li><li>Is seen as the Voice of the Patient and the HCP.
</li><li>Provides Strategic Leadership for the development of Clinical strategy across OUs relevant to the region in Medtronic sponsored studies, Collaborative Research and ERPs including execution of Clinical Research and Medical Affairs.
</li><li>Ensures that the studies are scientifically valid and meet all relevant regulatory requirements and be conducted within ethical guidelines.
</li><li>Leads execution for both local and global studies, manages clinical research projects across Medtronic therapies across multiple businesses.
</li><li>Ensures that all clinical studies are published based on a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.
</li><li>Partners with the OUs/Marketing regionally to seek insights and disseminate the published data both globally and regionally. This may be done through Advisory Boards (ABs) to seek advice, Focus Group Discussions (FGDs), Continuing Medical Education (CMEs), Round Table Discussions (RTDs), and webinars for safe and effective use of our products.
</li><li>Partners with Regulatory to contribute and partnering to implement regulatory strategies to obtain timely product approvals form worldwide regulatory bodies.
</li><li>Develop the Healthcare Professional (HCPs) and Key Opinion Leaders network and lead a strategic partnership and engagement.
</li><li>Develops and maintains a deep knowledge and understanding of the science behind our products and is seen as an internal expert. To also act as a Speaker in scientific meetings as the voice of the company.
</li><li>Responsible for the governance and compliance within the region. Ensures that all activities are executed as per the Medtronic Business Code of Conduct and local laws and regulations.
</li><li>Utilizes advanced subject matter expertise to provide medical input to various functions (General Management, Global Strategy &amp; Portfolio Management, Business Development &amp; Licensing, Research &amp; Development, &amp; Marketing) and Organizational Units to facilitate insightful decision-making and enable achievement of business objectives.
</li><li>Ensures effective objective value propositions are developed and articulated for Medtronic technologies to stakeholders (patients, health care providers, payers, government agencies, health technology assessment organizations, public) through appropriate channels.
</li><li>Responsible to interpret clinical trials/research, establishes and approves scientific methods for design and implementation of clinical protocols, and final reports.
</li><li>Proactively develops current competitive intelligence in our product space.
</li><li>Represents Medtronic from Clinical Research and Medical Sciences perspective within the region and collects feedback from local customers and authorities.
</li><li>Builds and maintains a strong network and close relationship with the various internal and external parties
</li></ul><p></p><p><b>Qualifications/ must have
</b></p><ul><li>10 years of relevant experience within clinical research &amp; medical sciences with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience.
</li><li>University degree &ndash; medical or scientific discipline.
</li><li>Proven strategic thinking, stakeholder management, and team leadership.
</li><li>Fluent in English and local language.
</li><li>Strong communication and networking skills.
</li></ul><p></p><p><b>Nice to have
</b></p><ul><li>Experience in international and cross-functional environments preferred
</li></ul><p></p><p>To be successful in this role you must be an excellent communicator, able to drive change by influence (internally as well as externally) and have strong managerial skills/experience.
</p><p></p><p><b>Physical Job Requirements
</b><br>
<br>
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
</p><p></p><h1 class="jobSectionHeader"><b>Benefits &amp; Compensation
</b></h1><p><b>Medtronic offers a competitive Salary and flexible Benefits Package
</b><br>
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.<br>
<br>
</p>This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
<p></p>This position is eligible for an annual long-term incentive plan.
<p></p><h1 class="jobSectionHeader"><b>About Medtronic
</b></h1><p>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
<br>
Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
<br>
We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.</p></div><p></p>

TuRMECA Clinical Research and Medical Science Director

Medicals International

<div>
 <p>
  Line: Glaucoma/ Ophthalmology
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Main Function:
   </u>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  To handle technical and clinical support for the Glaucoma line at MI, and regional support to all MI offices.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Duties , Responsibilities &amp; Standards of Performance:
   </u>
   &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
  </strong>
 </p>
 <p>
  <strong>
   &nbsp;
  </strong>
 </p>
 <p>
  <strong>
   Technical Function:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Becomes highly knowledgeable &amp; specialized in the Glaucoma field.
 </p>
 <p>
  2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Understands the clinical function and operation of all glaucoma product line.
 </p>
 <p>
  3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Trains in the proper application of use of our glaucoma products.
 </p>
 <p>
  4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Understands and analyze competitors&rsquo; products in relation to our product line.&nbsp;&nbsp;Build a comparative chart out of this analysis
 </p>
 <p>
  5.&nbsp;&nbsp;&nbsp;Training, coaching and developing team members.
 </p>
 <p>
  6.&nbsp;&nbsp;&nbsp;Share with sales team all useful tips about our products.
 </p>
 <p>
  7.&nbsp;&nbsp;&nbsp;Supplies clinical and technical know-how to his team, sales and to clients.
 </p>
 <p>
  8.&nbsp;&nbsp;&nbsp;Provides necessary training for colleagues, practitioners and assistants about products and their use by assisting in operations &amp; doing demonstrations &amp; presentations
 </p>
 <p>
  9.&nbsp;&nbsp;&nbsp;Help supporting surgeries where our team will need.
 </p>
 <p>
  10.&nbsp;&nbsp;&nbsp;Ensure Success of clinical Demonstrations of our product.
 </p>
 <p>
  11.&nbsp;&nbsp;&nbsp;Handles calls from customers related to clinical support of Glaucoma line.
 </p>
 <p>
  12.&nbsp;&nbsp;&nbsp;Attends surgeries, develop training for Drs , demos, wet labs&hellip;
 </p>
 <p>
  13.&nbsp;&nbsp;&nbsp;Responsible for responding to customer&rsquo;s &amp; clients request efficiently and effectively.
 </p>
 <p>
  14.&nbsp;&nbsp;&nbsp;Handles customers&rsquo; complaints professionally.
 </p>
 <p>
  15.&nbsp;&nbsp;&nbsp;Is responsible for keeping a professional image of the company by having high work ethics, superior product knowledge and solid information about products, procedures &amp; competition and by spreading knowledge.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Sales, Marketing &amp; Business Unit Management:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ol>
  <li>
   Develop in conjunction with suppliers and various MI units achievable but progressive targets.
  </li>
  <li>
   Ensure by working close with field sales leaders and team members that targets are achieved.
  </li>
  <li>
   Work on marketing budget and product best positioning with doctors in related exhibitions and workshops.
  </li>
  <li>
   Ensure best product representation on all levels.
  </li>
  <li>
   Coordinate with speakers and experts in the field to develop skill transfer courses and workshops.
  </li>
  <li>
   Prepare Routine memos about clinical updates / and product information.
  </li>
  <li>
   Medical marketing to highlight technical reasoning of our products against other competitors which will help our sales team selling against competitors with high added value.&nbsp;
  </li>
  <li>
   Setting up internal technical training for our team / coaching and developing team members in all MI offices.
  </li>
 </ol>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Special conditions for the Job:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  Job location is Riyadh with reporting to local Managing Director &amp; to Head of Ophthalmology at MI.
 </p>
 <p>
  Job requires traveling &amp; excellent command of English.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Knowledge:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <span>
   Ideal candidate will have either a Medical Doctor Degree or a Masters in Science with at least 10 years relevant experience.
  </span>
 </p>
 <p>
  <span>
   Candidates from different medical specialties are welcome.
  </span>
 </p>
 <p>
  <br/>
 </p>
</div>


Director, Glaucoma line & Clinical Application Expert

Aga Khan University

<div><div>Research Specialist, CAMMS Trial, Community Health Sciences - (250002RS)</div><div><div><br>
</div><p><b>Introduction</b></p><p>
Aga Khan University chartered in 1983 as Pakistan's first private international university, is committed to the provision of education, research, and health care of international standards relevant to Pakistan and the region. The affiliated Aga Khan University Hospital provides state-of-the-art clinical facilities and well-equipped diagnostic services. The University currently has teaching sites in Pakistan, East Africa, the United Kingdom, and Afghanistan, and is a major component of Aga Khan Development Network.</p><p>
As an equal opportunity employer, AKU believes in promoting a diverse and inclusive culture and is committed to adopt appropriate standards for safeguarding and promoting a respectful relationship with and between diverse workforce of its faculty, staff, trainees, volunteers, beneficiaries, wider communities, and other stakeholders with whom it works, including children and vulnerable adults and expects all employees/trainees and partners to share this commitment.</p><p>
The Department of Community Health Sciences (CHS) is the leading unit of its type in Pakistan, recognized regionally and internationally for the relevance, quality, and extent of its work in support of public health and the development of primary health care systems. It comprises of five major operational sections: Epidemiology &amp; biostatistics, Health policy &amp; management, Population &amp; reproductive health, Environmental health &amp; climate change, and non-communicable diseases &amp; mental health.</p><p>
This is a grant-funded contractual position.</p><p><b><br>
Responsibilities</b></p><p>
You will responsible to:</p><ul><li>
monitor day-to-day clinical trial activities within the hospital</li><li>
ensure smooth functioning of trial procedures in collaboration with hospital staff</li><li>
address clinical queries and deviations as per standard procedures</li><li>
keep track of study participants&rsquo; progress while during pregnancy, labor, and post-partum while still enrolled in the trial</li><li>
facilitate timely admission and coordinate patient care according to the study protocol and in emergency if needed</li><li>
complete clinical report forms (CRFs) with accuracy using REDCap</li><li>
maintain detailed clinical documentation for each enrolled participant</li><li>
submit weekly and monthly activity and patient follow-up reports to project coordinators</li><li>
facilitate refresher trainings for hospital and field staff related to the clinical trial</li><li>
provide supportive supervision and maintain staff motivation for protocol compliance</li><li><div>
maintain effective communication with project coordinators, hospital staff, and trial participants</div></li><div></div><li><div><br>
ensure respectful, culturally sensitive communication with participants in Sindhi and Urdu.</div></li></ul></div><div></div><div><div><br>
</div><p><b>Requirements</b></p><p>
You should have:</p><ul><li>
MBBS from a recognized medical institution.</li><li>
MCPS in Obs/Gyn</li><li>
valid PMDC registration</li><li>
one-year internship completed, with at least six months in Obstetrics and Gynecology.</li><li>
at least 3 years of OBGYN experience after internship</li><li>
clinical competence in obstetric care and postpartum monitoring</li><li>
accuracy in clinical assessment and documentation</li><li>
good communication skills in Sindhi and Urdu</li><li>
basic computer proficiency (MS Word, Excel)</li><li>
ability to work collaboratively within clinical and research teams</li><li>
strong organizational and time management skills</li><li>
knowledge of ethical standards and patient confidentiality.</li></ul><div>
</div></div><div>
Primary Location: Pakistan</div><div>
Organisation: Aga Khan University Pakistan</div><div>
Employee Status: Regular</div><div>
Job Type: Standard</div><div>
Job Posting: 17/10/2025, 12:05:57 AM</div><div>
Closing Date: 24/10/2025, 1:59:00 PM</div></div>

Research Specialist, CAMMS Trial, Community Health Sciences

Medpace, Inc.

Job Summary </br><p>We are seeking several Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required.</p></br><p>We are currently seeking Medical Directors in the following Therapeutic Areas:</p></br><ul></br><li>Neurology / CNS</li></br><li>Oncology (adult)</li></br><li>Cardiology (adult)</li></br><li>Gastroenterology</li></br><li>Metabolic / Endocrinology</li></br><li>Radiology</li></br><li>Infectious Disease</li></br><li>Immunology</li></br><li>Nephrology</li></br><li>Psychiatrist</li></br></ul></br><p><b>We are open to various locations throughout Europe. All Medical Directors have hybrid WFH flexibility. This role also has the ability to be fully remote with the right experience.</b></p></br> Responsibilities </br><ul></br><li>Provide medical management and expertise for clinical trials;</li></br><li>Contribute medical expertise to study reports, regulatory documents, and manuscripts;</li></br><li>Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials;</li></br><li>Participate in new business development through involvement in proposal and sponsor meetings as requested;</li></br><li>Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents;</li></br><li>Follow specific research related protocol and lead others in strict adherence to the policies.</li></br></ul></br> Qualifications </br><ul></br><li>Must have an M.D. with board certification and current medical licensure;</li></br><li>Must have prior clinical trial research experience; and</li></br><li>Previous experience in pharmaceutical-related clinical research is preferred.</li></br></ul></br><p><b>Travel</b>: up to 20%</p></br> Medpace Overview </br><p>Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.</p></br> Why Medpace? </br><p>People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.</p></br><p>The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.</p></br><p><b>Medpace Perks</b></p></br><ul></br><li>Flexible work environment</li></br><li>Competitive compensation and benefits package</li></br><li>Competitive PTO packages</li></br><li>Structured career paths with opportunities for professional growth</li></br><li>Company-sponsored employee appreciation events</li></br><li>Employee health and wellness initiatives</li></br></ul></br><p><b>Awards</b></p></br><ul></br><li>Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024</li></br><li>Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility</li></br></ul></br><p><b>What to Expect Next</b></p></br><p>A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.</p><img src="https://www.jobg8.com/Tracking.aspx?tmjKrTVbLoprzb9nV8nGLqknbbR%2fB8t8r" width="0" height="0" />

Therapeutic Area Medical Director

Evolution Research Group

<div><p><b>About Company:</b></p><p>
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.</p><p><b>
Why join us?</b> We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.</p><p><b>
Job Description:</b></p><p>
The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.</p><p><b>
Responsibilities:</b></p><p><b>
General</b></p><ul><li>
Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.</li><li>
Develop draft source documents and review the documents for accuracy and clarity prior to study start up.</li><li>
Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.</li><li>
Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.</li><li>
Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.</li><li>
Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.</li><li>
Serve as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.</li><li>
Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.</li><li>
Contribute to the SOP review and development as delegated by the Site Director.</li></ul><p><b>
Study Management</b></p><ul><li>
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.</li><li>
Attend the investigator meeting for each assigned protocol, as appropriate.</li><li>
Completion of IRB study renewals and maintain copies of all IRB communications.</li><li>
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.</li><li>
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator</li><li>
Review and obtain informed consent from potential study volunteers.</li><li>
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.</li><li>
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.</li><li>
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Perform study close-out procedures.</li><li>
Store study records appropriately</li><li>
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.</li></ul><p><b>
Skills and Qualifications:</b></p><ul><li><b>
Education and experience</b><ul><li>
High School Diploma or its equivalent; College degree preferred.</li><li>
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator</li><li>
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.</li><li>
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.</li><li>
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.</li><li>
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.</li></ul></li><li><b>
Requirements</b><ul><li>
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.</li><li>
Excellent communication skills (interpersonal, written, verbal)</li><li>
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)</li></ul></li></ul></div>

Clinical Research Coordinator-FT CRC

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