Quality Recruiting. Established Experts.
Vice President, Clinical Development
Reference Number: 3951
Location: MA
Our client is a clinical-stage biopharmaceutical company developing novel therapeutic compounds. They have asked us to assist them in their search for a Vice President, Clinical Development.
Major tasks and responsibilities will include:
- Builds and organizes the clinical development team.
- Designs and implements the clinical development strategy and clinical protocols.
- Delivers high quality clinical programs, from first-in-human trials, through to full development (Phase 3 and potentially Phase 3b/4).
- Serves as the medical lead for clinical stage programs.
- Oversees all medical aspects of the operational conduct of clinical studies (e.g. safety/benefit risk determination, protocol deviation review, clinical quality, etc.), partnering closely with heads of clinical operations, pharmacovigilance, clinical quality, and biometrics.
- Provides medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc.
- Serves as the primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
- Represents the company to all external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
- Responsible for the medical integrity of clinical study reports and data interpretation/communication.
- Authors clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.).
- Represents the company at regulatory meetings including presentation at Advisory Committee Meetings.
- Actively participates with the corporate leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted.
- Supports business development, potential product evaluation, and due diligence.
- Supports medical affairs by providing commercial and post-marketing insight to ensure effective clinical trial design and data generation.
- Participates in developing the strategy for filings outside the US.
- Develops and manages budgets required to implement clinical development plans, and regularly report plan progress to stakeholders.
- Provides medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Managed Care, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, data safety monitoring boards, patients, advocacy groups, etc.) customers.
- Works with Corporate Affairs Group to foster patient advocacy group relationships.
- Leads and conducts the performance management and merit process throughout the year for the clinical development team; this includes assuring clinical development employees are properly managed, qualified, and trained to perform their jobs effectively.
- Coaches, manages, and mentors direct reports while providing job enrichment and developmental opportunities.
- Assures timely goal and individual development plan setting.
We seek candidates with the following qualifications:
- Requires an MD, DO, or foreign equivalent.
- Must have a minimum of 5 years of management experience in the pharmaceutical industry within medical affairs, clinical development, or equivalent.
- Sub-specialization training or industry experience in hematology, nephrology, ophthalmology, or rare/orphan diseases highly preferred.
- Experience thriving in a small/entrepreneurial setting is highly preferred.
- Must be a team player with strong negotiation, problem-solving, and strategic influencing skills.
- Highly developed written and verbal communication skills required. Including the ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
- Requires the proven ability to perform successfully under stringent timelines and with changing and competing priorities.
If interested, please email your resume as a Word attachment to us, reference 3951. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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I have worked and dealt with a number of recruiting companies, but I have to say this has best my best interaction ever.
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Christopher is highly professional, energetic and efficient. He knows the pharmaceutical industry and was great at understanding my needs...
- Manager Outcomes Research, Major Global Pharmaceutical Company
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Dan… Now that I interacted with several head hunters, I think it is easy for me to say you are the best. You are sincere in finding a perfect match rather than making numbers and you do a very good job selling the truth about the position to the candidate and prepare the candidate for the interview. So keep doing what you do, you are very good at it.
- Director Drug Product Technology
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Jan is a true partner in the talent acquisition business. She is genuinely interested in making certain her clients are positioned to ensure long-term success for both parties. As a candidate, in preparation for the interview process, Jan was quickly able to provide me information about the position, the company, their culture, and key leadership profiles, ensuring I could best represent myself and critical skills and experiences that I brought to the table. Jan made sure all of my questions were immediately answered with quick and responsive communication. After accepting the position, Jan and I remain in contact today and she is always available to provide continued support and employment advice. She now provides me with recruiting assistance for my department and continues to remain true to form in assisting in the process on the employer’s side, while identifying the best talent for our needs.
- Senior Director Clinical Operations, Major Global Pharmaceutical Company
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
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Just wanted to take a quick moment to say thank you for all of your insights and coaching during my placement process at Novartis. I’m delighted to be joining such a wonderful team.
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Dan, I want to thank you for the work you have done with me for this position. It has been a great pleasure working with you. I have worked and dealt with a number of recruiting companies, but I have to say this has best my best interaction ever. And this is independent of the happy conclusion that should happen shortly with the signature of the offer letter. If someone needs an excellent professional in your field, your name will be at the top of my list.
- Medical Director Imaging, Major Global Diagnostic Imaging Company
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
- Director Strategic Start Up & Patient Recruitment, Major Global Pharmaceutical Company
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Jan was a true asset in helping me make my latest career transition. Her industry connections, sound guidance, and dogged determination proved invaluable for exploring/pursuing job opportunities. She proved an ally even after placement in navigating a particularly challenging situation during organizational realignment
- Director, Clinical Planning & Resource Management, Major Global Pharmaceutical Company
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Jan recruited me to my current position and always conducted herself in the most professional manner. She was a pleasure to work with through a time of transition. I highly recommend Jan.
- Medical Director, Drug Safety, Major Global Pharmaceutical Company
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I wanted to thank you for initial contact and support through the selections process with AbbVie. I greatly appreciated you championing me and submitting me for consideration. I am very excited to start my new job!
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I have had the pleasure of working with Ilanna. She expresses incredible knowledgeable of the pharmaceutical industry. Ilanna has deep understanding of the jobs she recruits for and consistently provides feedback. Her honest, detailed, direct, and sincere approach is what makes her stand out from the rest.
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Lee Golodny was the recruiter who eventually placed me at my new job. I was looking for a new career opportunity but had not had any success on my own with my networking. Lee contacted me through LinkedIn about a potential job at a small biotech firm. We discussed at length what I was looking for and he walked me through the process. He was very professional and I was impressed with him during the entire process. He followed up with me after every phone call, informal meeting, prepped me for the interview and helped me land a really great opportunity. Looking for a new job can be stressful but he made the process much easier for me. I hope others who may need that extra help will approach Lee to assist them in their job search.
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