Quality Recruiting. Established Experts.
Senior Director / Vice President, Clinical Development
Reference Number: 2678
Location: PA
Our client is a rapidly growing pharmaceutical company dedicated to revolutionizing vaccines. They have asked us to assist them in their search for a Senior Director / Vice President of Clinical Development.
The Senior Director / Vice President, Clinical Development reports to the Chief Medical Officer and has responsibility for individual clinical research programs as well as a pivotal role in the development of program-specific and overall clinical development strategies.
Major tasks and responsibilities will include:
- Direction of clinical development strategy and processes for specified projects within the company to ensure efficient, high quality prophylactic and therapeutic development programs, based on the highest scientific, medical, and regulatory standards.
- Accountability and ownership of clinical development plans, clinical concept sheets and protocols, confidential information brochures, data analysis plans, clinical study reports, and clinical sections of regulatory submissions (IND, CTA, and CTD).
- Medical monitoring of clinical research studies.
- Direction of peer-reviewed abstract and manuscript preparation and presentations.
- Initiation and development of strong scientific and medical relationships with consultants (e.g. thought leaders, clinical trial investigators, cooperative groups, academic centers, and community-based trials consortia) with particular focus on relationship building and understanding unmet medical needs.
- Ongoing interpretation of clinical safety, immunogenicity, and efficacy results for strategic and regulatory and pharmacovigilance purposes (e.g. expedited or periodic safety reports).
- Provides medical perspective to evaluate preclinical and early stage clinical development activities.
- Medical and scientific input to support best strategic positioning of the company's pipeline and provide medical and technical perspective to the Business Development function in the identification of potential partners.
- Attracts, assesses, retains, and develops highly competent, experienced clinical personnel who meet rigorous standards of team spirit, creativity, and technical depth.
- Setting of clear, focused, challenging targets that allow highly skilled and appropriately empowered clinical professionals to accomplish significant business objectives consistent with departmental goals.
- Creates and encourages an environment that stresses open, candid, and timely feedback relative to performance.
- Participates in a fast paced, results-oriented environment where the candidate’s knowledge and skill will be leveraged company-wide.
- Shares medical expertise with counterparts in other functional areas such as Manufacturing, Quality, Regulatory Affairs, R&D, Legal, and BD.
- Maintains knowledge of and complies with Good Clinical Practice (GCP) specifications as practiced in different geographies.
- Continuously develops and maintains "state of the art" level of knowledge as to developments and trends in medical sciences, especially in the designated therapeutic areas.
- Contributes to the development of the company's overall infrastructure and growth strategy.
- Creates and communicates a compelling vision inside and outside the company that generates excitement, credibility, and support of the clinic research mission.
We seek candidates with the following qualifications:
- MD degree (US/EU Licensure), preferably with specialty training, (e.g. internal medicine, oncology (preferred), infectious disease, critical care, BE/BC preferred for the US) or equivalent training or experience.
- Demonstrated knowledge of GCP rules and regulations.
- Excellent leadership skills; self-direction, requires only strategic guidance, good judgment in handling difficult situations.
- Teamwork oriented; interest in working in a multicultural and cross-functional environment.
- Professional attitude, maturity, confidence, and credibility to advise and influence senior management, strong business acumen, and impeccable integrity.
- Good organizational, time management, interpersonal, and conflict resolution skills. Resourceful with demonstrated management and tactical planning skills. Decisive and able to successfully manage multiple projects simultaneously.
- Well-developed interpersonal skills; strong in providing education on complex scientific/clinical issues in a crisp and clear manner both to a peer and larger audience.
- Excellent verbal and written communication skills, public speaking skills.
- Microsoft Office skills.
- 20-30% travel required.
Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2678. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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