Sr Director, Clinical Development, Pipeline

Insmed, Inc. Bridgewater , NJ 08807

Posted 2 months ago

Company Description

About Insmed!

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.


About the Role!

The Senior Director, Clinical Development will play an important role in working with the team to execute the global clinical development plans for INS 1007 molecule and potentially other investigational molecules.

Tasks include preparing clinical documents (e.g. protocol, study report, IND & NDA documents), providing medical oversight for investigational sites, doing research, and participating in and providing medical/scientific leadership to study team(s). This position will require working in a fast-paced, high energy, entrepreneurial environment and reports to the Vice-President of Clinical Development.

This is a non-supervisory position


Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study

  • Provide medical monitoring and direct interaction with investigational sites, investigators, and when appropriate Key Opinion Leaders

  • Provide medical expertise where needed (which may include assisting colleagues in Pharmacovigilance).

  • Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.

  • Provide program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs.

  • Support preparation of abstracts, manuscripts, presentations, and materials for Advisory Meetings.

  • Present protocols and supporting presentations at Investigator Meetings and as needed for other meetings or training purposes.

  • Provide medical/scientific review of statistical analysis.

  • Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, coding, report development and database lock processes.

  • Keep up to date on scientific and medical progress in the area of development and actively develops and maintain relationships with outside experts. May serve as a liaison by representing the company in outside groups.

  • Participate in due diligence work as needed.


About You!

  • Requires an MD/DO or equivalent medical degree. Specialization in pulmonary or immunological disease areas is a plus. Experience in rare or orphan diseases is highly desirable.

  • At least 10 years of clinical development experience in the pharmaceutical/biotech Industry is required.

  • Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.

  • Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders, within and outside of Insmed.

  • Must have excellent communication skills (verbal and written).

  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.

  • Must have strong analytical skills.

  • Must work well both independently and in teams, have excellent time management skills and be able to work well under pressure.

  • Vendor management experience is a plus.

  • Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions.

  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

  • Must have a global perspective and mindset, with the ability to work effectively with colleagues from myriad of cultures, backgrounds and geographies

Additional Information

Travel Requirements:

  • Up to 25% travel, both domestic and/or international, with periods of 50% and more travel.

  • Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

  • Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

  • Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Research Director I&I


Posted 4 weeks ago

VIEW JOBS 5/7/2020 12:00:00 AM 2020-08-05T00:00 Description: * The Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, is responsible for contributing to the creation and execution of the clinical development strategy for Dupilumab in different indications. The CRD is expected to contribute to the growth of Dupilumab by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging "the status quo". Principal Duties & Responsibilities: * Based upon an in-depth scientific understanding and extensive clinical experience, the CRD is responsible for: * Drafting the abbreviated protocol of studies that he/she will be responsible for, and lead the creation of the clinical development plans (CDP), the clinical sections of integrated development plans (IDP), as well as overseeing the execution of such plans by the respective operational units in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs). He/she will also represent the project in relevant teams and the protocol review committee and review and comment the Investigator's brochure. * Lead and write clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP * Assisted by related Sanofi Genzyme functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials. * Defends the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The CRD may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis the CRD will be requested to contribute expertise 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. Scientific and Technical Expertise: * This position requires a strong scientific and clinical foundation in dermatology or respiratory or allergy as well as in all aspects of drug development. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. * Has and maintains deep scientific, technical and clinical expertise in dermatology or respiratory or allergy and related areas * Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest * Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products * Maintains visibility within the Immunology & Inflammation Therapeutic Area in general and more specifically in dermatology or respiratory or allergy to maintain credibility with internal and external stakeholders * Ensure that all development activities are proactively planned and targeted towards timely achievement * Interacts with opinion leaders and consultants. * Owns (in collaboration with Project Team), the "Abbreviated protocol" for individual studies, the clinical sections of BLA, CDP and the clinical sections of the IDP and is responsible Clinician for the implementation of clinical strategy * Influences the definition of the product value proposition 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 Complex problem solving * As CDPs, BLAs/CTDs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required. * An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges. Regulatory Responsibilities: * Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project * Responsible for BLA clinical sections * Ensures clinical data meets all necessary regulatory standards * Supports registrations, label submissions and modifications * Participates in Advisory Committee preparation Scientific Data Dissemination: * Ensures timely submission and dissemination of clinical data * Participate and author manuscripts and abstracts * Supports the planning of advisory board meetings * Establishes and maintains appropriate collaborations with knowledge experts * In addition to the above activities the CRD must ensure that his/her contributions to the Global Project Team are conducted in compliance with current regulations, laws and guidance from FDA, EMA, and CHMP, as well as with Sanofi's policies and procedures. Basic Qualifications: * Medical Doctor, PhD desirable. Should be board certified or eligible in dermatology, or respiratory, or allergy or Immunology or * Must have completed education and training at a medical school * More than 5 years of clinical or scientific, or more than >10 years industry, experience within I&I or dermatology or respiratory (pulmonology, rhinology, ENT) drug development * Strong scientific and academic background with deep understanding of the disease * Clinical research experience in dermatology, allergology, respiratory drug development preferred * Good networking ability in cross-cultural environment * Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization * Performance oriented with ability to work along agreed timelines and a focus on strategy and execution * Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills * Fluent in English (verbal and written communication) 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. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Apply For Role My Candidate Account Sanofi Bridgewater NJ

Sr Director, Clinical Development, Pipeline

Insmed, Inc.