Sr. Medical Development Director, Oncology ( R-08587)
Title:Sr. Medical Development Director, Oncology
Company:Ipsen Bioscience, Inc.
Summary / purpose of the position
The Senior Medical Development Director (Sr MDD) 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) in partnership with Global Project Teams and in accordance with Target Product Profiles (TPP) as jointly developed with 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 Sr. MDD has oversight in managing a team of Medical Development Directors (MDDs) and Clinical Scientists.
- Recognized as an influential leader, 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
- Ensures from a medical perspective compliance with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities
- Works closely in partnership with Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Global Franchise Oncology in providing medical support for drug development programs
- Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results.
- Manages effectively relationships in a cross functional and matrix environment with internal and external stakeholders
- Advises Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions.
- May provide pivotal medical input to Ipsen’s individual drugs, including but not limited to recently acquired assets, and to support regional and/or global drug development
Main responsibilities / job expectations
Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%)
- Lead and manage the team, including recruitment, people development, talent management and performance management.
- 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 Asset Lead, 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
- 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
- Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with CRO representatives
- 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 R&D Oncology TA at investigator meetings, advisory boards, scientific conference or alike
Core Remit of Activities External to Therapeutic Area Development (approx. 35%)
- 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
- Provide upon request tactical support to Joint Development Committees, Joint Steering Committees and Due Diligence Teams
- Proactively liaise with Global Drug Discovery to ensure scientific and medical integrity of IDP, TPP etc.
- Liaise with key internal experts as required to support pre-clinical programs and Project Teams for most efficient development of new chemical entities
- Liaise with Early Clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies)
- Liaise with Late Drug Development platform and 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
- Oversight, management, development and mentorship of team.
- 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.
- Proactively and reactively inform, as appropriate and legally required, Global Drug Safety, Project Team, Clinical Study Team and functional leads of :
- Any safety signals emerging from clinical trials
- Any emerging medical risks and opportunities with an impact on timely and successful completion of development programs
- 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
Knowledge, abilities & experience
Education / Certifications:
- Medical doctor, board certified in oncology or proven expertise in oncology drug development is preferred
Knowledge & Experience:
- Minimum 5 years’ proven experience in oncology development area (from pre-clinical to registration).
- Industry experience an asset.
- Strong leadership skills in global matrix environment
- Substantial practical and academic experience (preferably with clinical trial experience); state-of-the-art medical, scientific knowledge; and track record of successful publications
- 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)
- Ability and willingness to assume domestic and international travel
- Ability and willingness to work in a global matrix organisation and in cross-functional teams
Key Technical Competencies Required
- Strategic and creative thinking. Find and develop unique opportunities to create value by enabling a provocative and creative dialogue among people who can affect Ipsen's direction. Have a good knowledge of the fundamental drivers of a business and rigorously challenging conventional thinking about them (capacity to think out of the box), in conversation with others. Broad an individual's perspective to achieve innovation, competitive edge or more successful outcomes.
- Influencing and leadership. Enable, motivate, coach, and inspire the team and the stakeholders to meet deliverables within project constraints by demonstrating commitment, expertise, confidence, genuine concern, and ability to help everyone solve challenges and achieve goals.
- Collaboration / Teambuilding. Establish a collaborative culture where people with unique personalities and skills happily work together towards a unified goal. Build relation with a wide spectrum of internal and external academicians, in the scientific/medical arena.
- Drug Development Value Chain expertise. Have a strong knowledge of the value chain from gene sequencing to distribution and specially of the Clinical Trials (Phases I, II, and III).
- Learning Skills. Find ways to stay current. Become actively involved in medical societies within the community you serve. Maintain high level of knowledge about ethic and compliance referential.
- Planning. Organize tasks in the right order, to hit the right outcome at the right time to maintaining a high level of professionalism regardless of tight deadlines and pressure.
- Decision-Making. Make prompt, informed, and fact-based decisions for the good of the project.
- Results-orientation. Focus on the activities needed to move the project forward and do them; review and assess the results of the performance, and then provide and receive continuous feedback to improve the overall performance for future iterations.
- Communication. Lead and manage people through two-way communication, by expressing ideas and expectations clearly, and listening attentively to team members and stakeholders.