Senior Medical Director
Proclinical is currently recruiting for a Senior Medical Director for a biotechnology company located in Boston, MA. Successful candidate must be an MD with Clinical Development experience. Successful candidate will be responsible for designing and executing clinical studies, helping to create the clinical development plan for new compounds, and to pave a path towards regulatory approval.
- Hands-on involvement in the design and writing of oncology clinical study protocols from first-in-human phase 1 through phase 2 and phase 3 pivotal studies that will support regulatory approvals.
- Medical monitor for multiple ongoing clinical trials, including evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity.
- Writing clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs .
- Leading regular teleconferences with academic clinical investigators.
- Attending and supporting clinical site initiation visits.
- Provide strategic leadership in the existing and planned clinical programs to support global filings.
- Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation.
- Work closely with R&D team, regulatory affairs, and consultants to assure timely filing of all clinical applications.
- Work closely with Pharmacovigilance on development of Risk Management Plans.
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
- Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders.
Skills and Requirements:
- MD with oncology focus in academia or industry.
- Board Certification or Board Eligibility (preference only) in adult or pediatric oncology and/or hematology.
- Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs. Experience with high-complexity first-in-human studies is highly desired.
- Extensive experience in the biotechnology or pharmaceutical industry including direct experience leading thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance.
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
- Ability to travel domestically and internationally, approximately 25%.
- At home in a results-driven, highly accountable environment where you can make a clear impact.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely and consistent manner.
- Passionate about working in a start-up/growth culture.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Stevens at (+1) 646-693-0610 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.