Massachusetts Green Jobs

Job Title: Clinical Research Director

Location : Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Clinical Research Director (CRD) 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:

• Lead the conduct of the clinical study(ies) under his responsibility at both strategic and operational levels

• Be responsible of the medical documentation associated with the clinical study(ies) (e.g. protocol, clinical study report, …)

• Participate to the program life cycle strategy, including selection of new indications

The CRD:

• Reports to the Global Project Head

• Interacts with the other CRDs in the project, as well as with the Global Project Head,

• Collaborates with functions to ensure full strategic and operational alignment (pharmacovigilance, regulatory…)

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Leading the clinical development plan strategies:

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

• Responsible for key results preparation

• Collaborate 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

• Raise study or project-level issues to the Clinical Lead and/or Project Head when needed

• Contribute to the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects

• 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

• Develop the abbreviated protocol, the final protocol and protocol amendments and the clinical study report

• Responsible for key results preparation

• Contribute to the ICF WSI and TDF development

• Co-Develop the SAP in collaboration with other CRDs and bio stats

• 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

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

• Provide medical support to clinical operation team during the clinical feasibility

• 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 medical questions raised by EC/IRBs, sites

• Develop the clinical study report

• 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 to the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP

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

• Ensure 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 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

About You

Experience

• Understanding of pharmaceutical product development and life cycle management gained through 3 years of development and medical experience

• Very good scientific and medical/clinical expertise

• Very good expertise in clinical development and methodologies of clinical studies

• Very good 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

• 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

Minimum Level of any Required Qualifications:

• Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)

• 3 years in pharmaceutical industry or CRO, previous experience in clinical development

• Moderate computer skills

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)