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Senior Clinical Research Director, Immunology - Inflammation in Cambridge, Massachusetts

JOB DESCRIPTION

Senior Clinical Research Director

The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs .

The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks.

The role of the Senior CRD is to:

  • Lead the development of the program clinical strategy (including Life Cycle strategy), integrating the commercial strategy and the Therapeutic Area (TA) general orientation

  • Oversee all the medical documentation generated throughout the program life (protocols, clinical study reports, clinical sections of IB, briefing books…)

The senior CRD:

  • Reports to the Global Project Head (GPH)

  • Manages the other CRDs on the same program

  • Leads the global clinical team

  • Works with the alliance counterpart to reach alignment on the clinical strategy

  • Collaborates with functions to ensure full strategic and operational alignment

  • As direct manager of the program CRDs, the senior CRD may occasionally have to deliver on the CRD role:

  • Provide medical expertise to the clinical 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 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

Key responsibilities include:

Lead the clinical development plan strategy:

  • Establish Target Product Profile (TPP) and Target Value Proposition (TVP) and contribute to the commercial and market access strategy (in collaboration with respective functions), by providing input on existing clinical needs and approaches to clinical development strategies

  • Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)

  • Preparation of documents and presentations for internal and alliance governance meetings

  • Manage other CRDs within the project, ensure leadership, build consensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project and study teams

  • Raise study or project-level issues to the Global Project Head

  • Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators

  • Evaluate relevant medical literature and status from competitive products

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

  • Review and validate the Abbreviated Protocol (AP), clinical study protocol, Statistical Analysis Plan (SAP), Key result Memo (KRM) and Clinical Study Report (CSR)

  • Oversee the program CRDs in the following activities (may occasionally need to take on the CRD role)

  • Develop the abbreviated protocol

  • Develop the final protocol and protocol amendments

  • Review the ICF WSI and TDF

  • Co-Develop the SAP in collaboration with biostats team

  • Prepare key results memo

  • Develop the clinical study report

  • 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)

  • Medical support to clinical operation team during the clinical feasibility

  • Review and provide clinical input across different study documents CRF, e-diary, monitoring plan

  • Ensure continuous medical review of aggregated data during clinical trial conduct (DSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and Global Safety Officer

  • Lead the study specific committees (IDMC, steering com, adjudication …) with operational support

  • Answer to medical questions raised by EC/IRBs, sites

Responsibilities related to regulatory and safety activities: Represent the program at key regulatory agency meetings as the medical spokesperson Lead the strategy and structure of the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP Support registrations, label submissions and modifications Participates in Advisory Committee preparation Review and validate the clinical sections of the Investigator’s Brochure (IB), CTA, IND, DSUR, DRMP… Oversee the program CRDs for the following activities:

  • Write the clinical sections of the IB, CTA, IND, DSUR, DRMP…

  • Write the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP

  • Ensure clinical data meets all necessary regulatory standards

Scientific Data evaluation and authorship:

  • Participate and author manuscripts and abstracts

  • Support the organization of advisory board meetings

  • Establish and maintain 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

Experience

  • Understanding of pharmaceutical product development and life cycle management gained through at least 4 years of clinical development and medical experience

  • Experience in late-stage clinical development program and regulatory submission

  • 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 capability to challenge decision and status quo with a risk-management approach

  • Ability to negotiate to ensure operational resources are available for continued clinical conduct

  • Fluency in written and spoken English

  • Excellent 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

Minimum Level of any Required Qualifications:

  • Medical Doctor (MD) preferred: specialist, English fluent (spoken and written), certification in pulmonary medicine is a plus

  • At least 4 years in pharmaceutical industry or CRO, previous experience in clinical development

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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