Development Medical Director - Clinical Research Director

Sanofi•Cambridge, MA

1d•Onsite

About The Position

Join the engine of Sanofi’s 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 Development Medical Director (DMD) 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 deliver to multiple operational tasks.

Requirements

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)
Previous experience in clinical development
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 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

Nice To Haves

specialization in dermatology or allergology or GP with experience in dermatology development
Atopic Dermatitis or Hidradenitis suppurative preferred

Responsibilities

Collaborate with other medical and clinical scientific experts DMDs or Development Scientific Directors (DSDs) in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
Provide clinical scientific expertise in the Study team to conduct the clinical studies from early phases to LCM programs
Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)
Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answer to questions from health authorities.
Be the scientific & medical reference in the Study team, ensuring the medical relevance of the clinical data
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
Evaluates 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
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,…)
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
Review and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, , 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
Collaborates with the Patient Safety GSO to detect and document any safety signal
Participates in Advisory Committee preparation
Participate and author manuscripts and abstracts
Establish and maintains appropriate collaborations with knowledge experts or advisory boards
Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams