Title: Sr. Director, Clinical Development, Rare Diseases Therapeutic Area Company: Ipsen Biopharmaceuticals Inc. About Ipsen Ipsen is a mid‑size global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K., we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human‑centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society. Job Description Recognized as an influential leader, the Senior Clinical Development Director develops, proposes, and influences asset teams on new uses for compounds currently in proof of concept and/or life cycle management. Provides solutions to senior managers in various areas, groups, and/or operations based on medical subject matter experience. Delivers high‑quality medical, scientific and strategic input and interpretation on specific product data in fulfillment of the development business objectives for registration. Leads the Clinical Development sub‑team of the allocated asset team, working in partnership with Regulatory Affairs and Global Patient Safety and other relevant functions to define the optimal development approach for the asset and indication. Provides medical leadership for asset development programs. Ensures from a medical perspective compliance with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities. Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results. Advises Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions. Acts as an independent and reliable resource to the Asset Lead, assisting in driving strategy and execution. Manages relationships effectively in a cross‑functional and matrix environment. Provides support for multiple indications within a global program. May provide pivotal medical input to support regional and/or global asset development for business development. Main Duties Support all medical, scientific, strategic and clinical matters for drug development programs from lead compound identification to product registration and launch. Establish a strategic clinical development plan (CDP) and objectives. Provide medical, scientific and strategic expertise and contribute to and/or prepare clinical trial related documents – investigator brochure, communication with regulatory authorities, clinical trial synopsis, clinical trial protocol, clinical summary, clinical study report, with the support of other R&D functions. Assume ownership of CDP and clinical development aspects of the integrated development plan (IDP), supervise CDP and IDP contributions of the Clinical Development team, ensure execution of CDP and establish cross‑functional alignment where necessary. Share responsibility of clinical trials oversight with Clinical Operations to ensure efficient, safe, ethical and high‑quality conduct of trials. Contribute to medical monitoring (including oversight of contracted medical monitors depending on outsourcing model of trials) to ensure data integrity and coherence of data interpretation. Support the conduct of clinical trials as part of the Clinical Study Team and interface with medical CRO representatives. Proactively and reactively inform, as appropriate and legally required, Global Patient Safety, Asset Team, Clinical Study Team(s) and functional leads of emerging medical risks and opportunities impacting timely and successful completion of development programs. Contribute to and review scientific communication (abstracts, articles, presentations) of Ipsen‑sponsored studies. Establish and maintain professional relationships with external medical experts and key thought leaders; represent Ipsen at investigator meetings, expert panels, advisory boards or similar as required. May work in a joint team setting with partner companies where applicable to the asset. Provide upon request support to Due Diligence Teams (together with Business Development and Scientific Affairs). General Duties and Responsibilities Comply with Ipsen’s SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research. Develop and maintain state‑of‑the‑art scientific, medical and managerial knowledge by establishing and maintaining an external professional network, reading pertinent scientific and medical publications, and attending pertinent training courses, workshops and conferences. Commit to support transformation and change management of the R&D division with a focus on high‑performance culture, data quality, timeliness and budget control accounts. Assume tasks within the context of team performance and project progress in an objective‑driven, solution‑and‑results oriented manner with an overall can‑do attitude. Be a proactive member and contributor to Ipsen’s community. Education & Experience Medical school (minimum MD title or equivalent) or equivalent academic education in life sciences (minimum PharmD, PhD title or equivalent). Minimum 10 years industry experience. Substantial practical and academic experience (preferably with clinical trial experience); state‑of‑the‑art medical, scientific knowledge. Substantial experience in pharmaceutical drug development and, in an industry context, track record of successful global clinical trials management. Rare disease or hepatology experience is preferable. Previous experience directly and independently leading projects and/or a team of professionals. Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others beyond one’s own function. Skills and Competencies Objective‑driven, solution and results oriented, with a solid sense of urgency. Excel in working in matrix organizations and project teams. Excellent priority setting, time management and organizational skills. Excellent verbal, written, interpersonal communication skills. Specifics Requirements Ability and willingness to assume domestic and international travel. Ability and willingness to work in a global matrix organization and in cross‑functional teams. Languages Fluency in English is a must; any other language is an asset. Salary & Benefits The annual base salary range for this position is $255,000 - $374,000. This job is eligible to participate in our short‑term incentives program. Ipsen offers a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short‑ and long‑term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well‑being allowance, commuter benefits, and much more. Equal Employment Opportunity Statement We are committed to creating a workplace where everyone feels heard, valued and supported; where we embrace The Real Us. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity, national origin, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
Sr. Director, Clinical Development, Rare Diseases Therapeutic Area
IPSEN BIOPHARMACEUTICALS INC.
cambridge, cambridge
Published 4 days ago
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