Global Program Clinical Head
Our client is a biopharmaceutical company. They have asked us to assist them in a search for a Global Program Clinical Head.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides clinical Leadership and medical strategic input for all clinical deliverables including the development and execution of the clinical strategy.
- Leads and actively participates in the creation of high-quality clinical and regulatory documents, including maintenance of product licenses and registration dossiers consistent with the IDP and TPP. Supports registration, market access, commercialization, and maintenance of product licenses for the compound(s).
- Drives the execution of clinical program(s) in partnership with global line functions, external consultants and Global Clinical Trial Team associates (CTT).
- Oversees/conducts ongoing medical/scientific review of clinical trial data; may serve as the clinical trial or program medical monitor.
- As the medical expert, leads interactions with external stakeholders, internal stakeholders, and internal decision boards.
- Supports Clinical Development by contributing to the Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs.
- Together with Pharmacovigilance (PV), ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and ongoing signal detection. Supports overall program safety reporting in collaboration with PV.
- Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s).
- Supports Clinical Development by leading the peer-review of CTPs, and other clinical documents across various indications and programs, fosters excellence in clinical trial strategy, design, and execution.
- Plans and executes publication and clinical communication strategies. Provides input into key external presentations.
- May support Business Development & Licensing (BD&L) activities including target identification and due diligences together with other clinical/medical matters, as needed.
- Ensures career development of program/matrix reports through active participation in talent review and succession planning processes. Provides on-boarding, coaching, and/or mentoring support.
- Is responsible for medical/scientific training of relevant internal and external stakeholders on the disease area and compound/molecule. May serve as speaker for medical/scientific training.
- May contribute to development of Clinical Development/TA strategies.
- Is a subject matter expert for SOPs or trainings, and/or contributes to other cross-functional or Clinical Development initiatives.
- A PhD or PharmD is required. A Medical degree is preferred.
- Requires at least eight years (Medical degree) or at least 12 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including global submission dossiers.
- Specialization in a subspecialty may be needed. Advanced clinical training/knowledge in medical/scientific area aligned with TA is required. Medical Board certification is preferred for Medical degree candidates. Clinical practice experience at least four years (including residency) is preferred for Medical degree candidates.
- Must be fluent in oral and written English.
- Advanced knowledge of assigned therapeutic area is required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data.
- Requires a thorough knowledge of Good Clinical Practice (GCP), clinical trial design, statistics, and global regulatory/clinical development process.
- Experience with submissions and US/EMA health authorities is required.
- The demonstrated ability to establish strong scientific partnership with key stakeholders is required.
- Requires demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry.
- Must have at least five years of people management experience. This may include management in a matrix environment.
- Considerable organizational awareness including significant experience working cross-functionally and in global teams is required.
- Must have excellent management, interpersonal, communication (both written and oral), and problem-solving skills.
- Excellent negotiation and diplomatic skills are required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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