Clinical Research Director

BioSpace · Cambridge, MA · 1 wk ago

On-siteAnalystFull-time

About the role

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The Clinical Research Director (CRD) is a key clinical lead in the Development of R&D programs. The role requires a well-organized, strategically, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver to multiple operational tasks.

Responsibilities

Leading the clinical development plan strategies: Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
Raise study or project-level issues to the project head and propose related corrective action plans
Contribute in the definition of the product value proposition (TVP), Target Product Profile (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 project
Collaborates with external partners, regulators, scientific experts and internal stakeholders
Evaluate relevant medical literature and status from competitive products
Lead, Support and oversee the execution of clinical development and studies activities
Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc), 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)
Develop the abbreviated protocol, the final protocol and protocol amendments
Develop/review the Core Study Informed Consent Form (CSICF)
Develop/review Study committee Charters
Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
Review and provide clinical input across different study documents Vendors RFPs, (e-)CRF, (e-)diary, (e- )CoA etc
Raise study or project-level issues to the project head and propose related corrective action plans
Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings
Answer to medical questions raised by HA, EC/IRBs, sites
Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,)
Raise study or project-level issues to the project head and propose related corrective action plans
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
Raise study or project-level issues to the project head and propose related corrective action plans

Qualifications

Medical degree (MD) with specialization in dermatology or allergology or GP with experience in dermatology development
Minimum 3 years in Clinical or Pharmaceutical industry experience (Atopic Dermatitis or Hidradenitis suppurative preferred)

Skills

Understanding of pharmaceutical product development and life cycle management
Very good Scientific and medical/clinical expertise
Very good expertise in clinical development and methodology of clinical studies
Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Excellent problem solving capability
Demonstrated capability to challenge decisions 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

Benefits

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.

Pay

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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. #GD-SA #vhd All compensation will be determined commensurate with demonstrated experience.

Schedule

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.