Senior Director, Clinical Development, Oncology

About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision. 

Role Summary

As Senior Director, Clinical Development (MD/DO) you will provide strategic medical guidance and lead the early clinical development of oncology agents in the Servier Oncology Early Clinical Development portfolio, beginning with the preparation of the Investigational New Drug Application (IND) and continuing through clinical proof-of-concept. In this role you will lead the Clinical Team and will be a key member of the program’s Core Team. You will provide medical expertise and oversight for clinical trials, ensuring the integrity of the studies, as well as compliance of clinical documents with GCP and ICH guidelines. You will provide patient safety accountability and be an expert medical reference for investigative sites and trial team members.

Primary Responsibilities

The role’s specific responsibilities include, but are not limited to:

• Build a clinical development strategy for new oncology agents that are within the candidate selection to proof-of-concept (PoC) timeframe. The development strategy should foresee and support future registrational trials and combines the Director’s medical knowledge with the expertise of colleagues in a wide range of other fields (e.g.,Asset Leader, Clinical Pharmacology, Biostatistics, Regulatory etc.).
• Lead the Clinical Team and collaborate with clinical scientists as well as colleagues from multiple disciplines and line functions to develop all relevant clinical documents, including clinical trial protocols, Investigator Brochure (IB), Informed Consent Form (ICF) and/or Case Report Forms (CRFs).
• Lead the IND Application, initiation and execution of clinical trials needed to demonstrate PoC.
• Perform medical review, assessment, and interpretation of all clinical data. Participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action. Work closely with the Pharmacovigilance and Safety representatives and provide medical input on safety reports including, Serious Adverse Event narratives and reports, Development Safety Update Reports (DSURs), Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Risk Management Plans, Integrated Summaries of Safety and Efficacy and Clinical Study Reports
• Provide medical support to investigative sites and project staff for protocol-related issues including protocol clarifications.
• Attend and present at Investigator Meetings and Site Initiation Visits (SIVs). Lead the medical discussion at the weekly/biweekly Investigator calls and Cohort Review meetings.
• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret its implications for clinical development, as articulated in the Investigator’s Brochure and clinical trial protocol.
• Apply medical knowledge to guide the safe, ethical and efficient conduct of clinical trials under their responsibility. Be knowledgeable in Good Clinical Practice (GCP) guidelines and Servier Standard Operating Procedures and strive to maintain compliance with them. Provide oncology training for the project clinical team.
• Liaise with outside specialists, investigators, and regulatory authorities in the field of oncology, and represent the projects to those groups and authorities.
• Write and review abstracts/manuscripts, etc. for presentation/publications at internal/ external meetings.
• Participate in due diligence, advisory board meetings, internal and external collaborations and task forces to support continuous improvement.

Education and Required Skills

• MD or DO degree required. Additional PhD degree is preferred
• Clinical experience and/or Board-certification in an oncology specialty. Additional laboratory-based science training is preferred.
• 3+ years of pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, 5+ years of academic experience in translational oncology and substantial clinical study experience is required
• Ability to interpret preclinical data in oncology (pharmacology, pharmacokinetics, pharmacodynamics and toxicology)
• Solid understanding of the application of Pharmacokinetics/Pharmacodynamics, biomarkers and biostatistics to clinical development and clinical trials
• Proven ability to analyze and interpret efficacy and safety data relating to oncology
• Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology
• Excellent medical/scientific writing skills. Effective written and oral communication skills. Proven track record of managing and developing a team is preferred
• Excellent personal ethical integrity and a dedication to improving the outcomes for patients with malignancies

Travel and Location

• Boston based preferred, remote working may be considered
• Travels as needed (estimated 10%)

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.