Senior Clinical Development Director

Ipsen; London; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Development Director to lead innovative drug development programs. This pivotal role involves providing medical leadership and strategic direction for clinical trials, ensuring compliance with regulatory standards while managing cross-functional teams. The ideal candidate will have extensive experience in the pharmaceutical industry, a strong academic background, and the ability to influence and drive results in a fast-paced environment. Join a forward-thinking company dedicated to transforming healthcare and making a meaningful impact on patients' lives.

Qualifications

• 10+ years of industry experience in clinical development.
• Strong background in leading clinical trials and project management.

Responsibilities

• Lead clinical development teams and ensure compliance with guidelines.
• Develop strategic clinical development plans and oversee trials.

Skills

Leadership

Clinical Development

Medical Expertise

Project Management

Communication Skills

Strategic Planning

Education

MD or equivalent

PharmD or PhD

Job description

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The Senior Clinical Development Director Position

• Recognized as 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/strategic input and medical/scientific interpretation on specific product data in fulfilment 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 (AL) 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 effectively relationships 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 in 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, contribute to and/or prepare 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 reports, with the support of other R&D functions
• Assume ownership of CDP and clinical development aspects of the integrated development plan (IDP), and supervises CDP and IDP contributions of the Clinical Development team; 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;
• sSupport 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, Asset Team, Clinical Study Team(s) and functional leads of

– 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 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.

– Attending pertinent training courses, workshops, conferences etc.

• 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 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 (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 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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