Senior Medical Director, Oncology Clinical Development

Location
Cambridge, MA, United States
Posted
Nov 29, 2018
Ref
R-00210
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Senior Medical Director, Oncology Clinical Development

Company:
Ipsen Bioscience, Inc.

Job Description:

Primary Purposes of Position

The position is responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsen's individual drugs (oncology) as directed by the Vice-President (VP) Therapeutic Area(Global Drug Development, GDDev) in partnership with Project Teams and in accordance with Target Product Profiles (TPP) as jointly developed with and provided by the Franchise. This position may also have a particular focus on leading the Global Project Team with overall accountability for a specific Drug Development program, designated as Global Development Lead (GDL).

The Senior Medical Development Director (SrMDD) position:
  • Recognized as influential leader, the Senior Medical Development Director (SrMDD), develops, proposes, and influences project and R&D 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/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration
  • Works in partnership with Regulatory Affairs and Global Drug Safety in providing medical support for drug 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 VP TA on critical issues deserving immediate attention and escalation, proposing actionable solutions. Acts as an independent and reliable resource to the TA Head, assisting in driving strategy and execution; acts as designee of the TA Head upon assignment.
  • Manages effectively relationships in a cross functional and matrix environment.
  • May provide pivotal medical input to Ipsen's individual oncology drugs, including but not limited to recently acquired assets, and to support regional and/or global drug development


  • The Global Development Lead (GDL), in addition to the primary purpose of the SrMDD role:
  • Ensures medical / scientific strategy and has full accountability for the strategy and medical/scientific accuracy on medical needs, hypotheses, trial designs to answer critical questions
  • Has final accountability and right of veto sits with the function that provides the fundamental input for and basis of programs


Main Duties
  • Core Remit of Activities Internal to Therapeutic Area Development (approx. 70%)
  • Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch
  • Participate with TA Head and other senior managers in establishing strategic plans and objectives
  • Provide medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP, RFIs/RFPs
  • Assume ownership of CDP and medical aspects of IDP, and supervises CDP and IDP contributions of MDDs; ensure execution of CDP and establish where necessary cross-functional alignment to support execution of CDP
  • Share with Clinical Operations responsibility of clinical trials oversight and ensure the efficient, safe, ethical and high-quality conduct of clinical trials
  • Contribute to medical monitoring (including oversight of contracted Medical Monitors depending on the respective outsourcing model of clinical trials) to ensure data integrity and coherence of data interpretation under the guidance of TPP and IDP
  • Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with medical CRO representatives
  • Proactively and reactively inform, as appropriate and legally required, Global Patient Safety, Global Project Team, Clinical Study Team(s) and functional leads of any safety signals emerging from clinical trials and/or any emerging medical risks and opportunities with an impact on timely and successful completion of development programs
  • Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
  • Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen GDDev at investigator meetings, expert panels, advisory boards or alike
  • Core Remit of Activities External to Therapeutic Area Development (approx. 30%)
  • Provide upon request tactical support to Joint Development Committees, Joint Steering Committees and Due Diligence Teams (together with Business Development and Scientific Affairs)
  • Proactively liaise with Global Drug Discovery (GDDis) to ensure scientific and medical integrity of IDP, TPP etc.
  • Liaise with Translational Sciences to support pre-clinical programs and Project Teams for most efficient development of new chemical entities and to provide medical expertise to early development programs (up to and including proof-of-concept studies)
  • Liaise with Global Franchises to both integrate business needs into IDP and to report progress of development programs with focus on patient safety and potential business risks and opportunities


  • 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
    • Attending pertinent training courses, workshops, conferences etc.
  • Commit to support transformation and change management of 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 medical community


Education & Experience
  • Medical school (minimum, MD title) or equivalent academic education in life sciences
  • Board-certification in Medical Oncology and/or Internal Medicine is preferred
  • Minimum 5 years Industry experience
  • Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications in Oncology
  • Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management
  • 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 (above and beyond ones' own function


Skills and Competencies
  • Objective-driven, solution and results oriented, with a solid sense of urgency
  • Excels in working in matrix organizations and project teams
  • Excellent priority setting, time management and organisational skills
  • Excellent verbal, written, interpersonal communication skills
  • Advanced presentation skills and knowledgable in IT tools for word processing and presentations


Specifics Requirements
  • Ability and willingness to assume domestic and international travel
  • Ability and willingness to work in a global matrix organisation and in cross-functional teams


Languages
  • Fluency in English is a must; any other language is an asset



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/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.