At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Medical Director to join our A-team (office-based*/remote). The Medical Director works independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent. Serves as the medical monitor contact in trial protocols to investigators and trial sites regarding protocol related questions and safety of the subjects enrolled. Advises investigators, project teams, and clients on safety issues arising from medicinal products, devices and trial designs undertaken by Allucent. Works along with more senior colleagues and internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and reporting standards. Reviews, if needed with support from more senior colleagues, protocols, investigator's brochures, clinical trial reports written by Allucent ensuring they are approved in accordance with Allucent procedures and good medical practices. Supports Business Development efforts with support of senior colleagues by reviewing the proposal and attending client meetings including Bid Pursuit Meetings.
In this role your key tasks will include:
Independently provide medical monitor support to assigned clinical trials, for example answering medical questions from trial team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
Provide input on Protocol design and Strategic clinical recommendations
Prepare the Medical Monitoring and other relevant plans for assigned trials conducted by Allucent prior to the start of the trial and in accordance to deliverables contracted.
Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
Assist clinical data management with MedDRA and WHO coding in assigned trials
Assist by reviewing clinical trial documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical trial report (CSR) other safety reports (e.g., DSUR, PSUR)
Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
Attend, participate and present in Kick-Off, Investigators' meeting, and other relevant meetings in assigned projects, as requested.
Provide 24/7 urgent medical support for medical and safety advice if required
Training of project teams on medical aspects of the trial and therapeutic training as required
Support protocol deviation guidance development and review of Protocol Deviations
Identify trial risks and provide input to the Risk plan · Ensure conduct of safety reviews to identify data issues, to evaluate data for safety and efficacy and to interpret trends including support to signal detection and evaluation strategies and risk minimization measures with support from senior colleagues
Independently review and understand trial medical deliverables laid down in the assigned trial's contract and track budget spent throughout their assigned trial(s)
Draft and contribute with the support of senior colleagues as Subject Matter Expert (SME) in the field of Medical Monitor activities to the evaluation/improvement of processes and procedures within the Quality Management System · Assure good communication and relationships with (future) clients
Support Business Development efforts with support of senior colleagues by reviewing the proposal and attending client meetings including Bid Pursuit Meetings
May advise and assist clients on product development, trial designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Allucent. Liaise with country managers and department heads at Allucent as needed to meet this task
May provide therapeutic consultation in support of the scientific, medical, and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.)
Assure strong long-lasting relationships with (future) key accounts
Support in preparation of new proposals
Contribute and take part in client evaluations, visits and bid defense
Contribute to other areas of business as required
Requirements
To be successful you will possess:
MD degree
Minimum 5 years of relevant work experience
Very good knowledge of GxP
Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Disclaimers:
*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices (https://www.allucent.com/careers) .
"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."
LI-Remote #LI-Hybrid #LI-TCW
