Associate Director, Clinical Science

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 

We are seeing an experienced Associate Director, Clinical Science to join our growing Late-Stage Life-Cycle Management Clinical Science organization.  This person will provide relevant clinical and drug development expertise in support of Clinical Science deliverables across one or more  early or late stage trials within the Oncology Therapeutic area (TA).  The ideal candidate will have the desire to proactively participate within a cross-functional team of internal colleagues, as well as the ability to interact with external experts and Investigators.  This individual will provide scientific expertise throughout the life-cycle management of a drug product including development of clinical protocols and amendments, review, evaluation and presentation of study data, contribution to clinical study reports, investigator brochures, publications, and regulatory documents.  The Clinical Scientist will also interact closely with the Medical Director to directly contribute to the overall clinical development strategy of the drug product. 

Primary Responsibilities 

1. Core Member of Clinical Study Team 

• Partner with Medical Director internally and externally as the primary clinical science lead of one or more clinical studies 

• Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Regulatory Authority information requests and/or briefing books, etc.  Conduct literature searches, draft background sections, and ensure that standardized disease/molecule specific language in incorporated (i.e. eligibility and dose modification criteria) 

• Primary point of contact for medically relevant inquiries related to the study from sites and site monitors, IRBs and/or health authorities; answer or triage questions as appropriate 

• Participate in CRF and CCG development. Perform clinical review of data listings and essential study data within generated statistical reports (eg, SAS outputs) and other available data surveillance tools (eg, Spotfire, Oracle Analytics) and partner with Medical Review Department and Data Management in generating relevant queries. 

• In conjunction with Medical Director, support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, Steering Committee Meetings, IDMC meetings, etc.) 

• Assist in the collection and compilation of data and coordinate review/submission to scientific meetings for abstracts/posters and other publicly distributed materials 

• Contribute to project level documents including Investigator’s Brochure, PSUR/DSUR, Signal Evaluation Reports, Briefing Books, etc. 

• Partner with Clinical Operations for site selection, site start-up activities, etc. 

• Build strong relationships with sites and KOLs and attend site visits (SIVs, booster visits) as appropriate 

2. Key Member of Clinical Subteam and/or Global Asset Team 

• Partner with Clinical Lead/Medical Director/Global Asset Lead to understand corporate strategy related to development of one or more Servier programs  

• Follow developments of competitive programs and/or trials in order to provide critical thinking on potential impacts program goals and strategy 

• Liaise with cross-functional departments including translational medicine, biostatistics/statistical programming, commercial, medical affairs, and regulatory as needed depending on stage of the studies and program  

3. Other duties as required or directed by the Manager or Functional Management 

• Serve as Clinical Science representative and provide relevant expertise for new process development initiatives and working groups as needed 

Education and Required Skills 

• Bachelor’s degree in a scientific or health-related field required; Advanced Clinical/Science degree preferred (e.g. PhD/MS, PharmD, MSN, MPH,) 

• Minimum of 5+ years (7+ with Bachelor’s degree) of clinical research experience and/or pharmaceutical industry experience (a focus on drug development is preferred) 

• Ability to work independently as well as interact and effectively communicate study level data and information with all levels of personnel within the organization and with clients of the Sponsor company (i.e., investigators, vendors and CROs) 

• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance, working knowledge or familiarity with data review tools including SAS, Spotfire or PowerBI a plus 

• Ability to serve on multiple interdepartmental teams and proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines 

• Understanding of product and safety profiles 

• Demonstrated strong organizational and interpersonal skills, building internal and external relationships, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail 

Travel and Location 

• Boston Hybrid Preferred: In-office minimum 2-3 days/week; If 100% remote, ability to travel to Boston at least quarterly

• Ability to travel up to 10-15% 

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. 

Salary Range 

The salary range for this role is $165,000-195,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.