Job title: Senior Clinical Research Director

• Location: Cambridge, MA

About the Job

The Senior Clinical Research Director (sCRD) is noted as the primary clinical expert for programs. The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

The role of the CRD is to:

• Reporting to the Global Project Head (GPH) or Principal Clinical Lead (PCL), interact with other CRDs in the project, PharmacoVigilance, Regulatory and other key functional reps.
• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report).
• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment).
• Contribute to the Extended synopsis and Protocol for their project.
• Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities.
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.

Main responsibilities:

Leading the clinical development plan :

• Responsible for clinical development plans and clinical sections of integrated development plans (IDP).
• Collaborate with other CRDs within the project, ensure leadership, buildsconsensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams.
• Raise study or project-level issues to the GPH and/or PCL.
• Contribute to definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and focus the research strategy, from a clinical perspective.
• Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators.
• Evaluates relevant medical literature and status from competitive products.

Lead, Support and oversee the execution of clinical development and studies activities:

• Review and validate the final protocol and protocol amendments.
• Review the ICF WSI and TDF.
• Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs).
• Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support.
• Co-Develop the SAP in collaboration with bio stats.
• Responsible for key results preparation.
• Develop the clinical study report.

Take on as necessary the CRD role:

• Develop the abbreviated protocol.
• Develop the final protocol and protocol amendments.

• Medical support to clinical operation team during the clinical feasibility.
• Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan.
• Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review.
• Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc).
• Participate in the elaboration of training material and presentations at the investigator meetings.
• Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, ...) with operational support, bio stat and GSO.
• Answer to medical questions raised by EC/IRBs, sites.
• Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function.

Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:

• Feasibility managers for feasibility preparation and validation of feasibility results.
• Medical Writers to develop, review and finalize WSIs, study protocols and reports.
• Clinical Scientists, Medical review team and Coding
• Pharmacovigilance (GSO, CME).
• CTOMs, Biostatisticians.
• CSU medical advisors for the best knowledge of the study, compound, protocol.
• TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs.
• CROs.
• Regulatory affairs.

• Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the global project head and clinical lead.
• Provide operational expertise to project clinical sub team, as needed.

Responsibilities related to regulatory and safety documents and meetings:

• Review and/or contribute in the clinical section of the Investigator's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP.
• Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
• Ensures clinical data meets all necessary regulatory standards.
• Participates in Advisory Committee preparation.

Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams.

About You

• Medical Doctor (MD), or equivalent.
• English fluent (spoken and written).
• Medical Oncology or Hematology/Oncology specialist.
• At least 4 years experience in pharmaceutical industry or biotech, in clinical development.
• Computer skills.

Experience:

• Understanding pharmaceutical product development and life cycle management.
• Excellent Scientific and medical/clinical expertise.
• Excellent expertise in clinical development and methodology of clinical studies.
• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Demonstrated ability to challenge decision and status quo with a risk-management approach.
• Ability to negotiate operational resources.
• Fluency in written and spoken English.
• Very good teaching skills, demonstrated ability to assist and train others.
• Ability to work within a matrix model.
• International/ intercultural working skills.
• Open-minded to apply new digital solutions.

The salary range for this position is:
$236,250.00 - $393,750.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.