Director/Senior Director, Drug Metabolism & Pharmacokinetics (DMPK)

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{
  "lists": [
    {
      "text": "Qualifications",
      "content": "<div>\n\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Drug Metabolism, or related discipline</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">12+ years of industry experience in DMPK within biotech or pharmaceutical settings</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Demonstrated success advancing small molecule programs from discovery through IND</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Deep expertise in ADME, human PK simulations, PK/PD modeling, and translational science</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Experience working in or with early-stage companies, with comfort operating in resource-constrained, fast-paced environments</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Strong track record of managing external CROs and consultants, and delivering high-quality data</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Excellent communication skills, with the ability to influence cross-functional teams and leadership</span></li>\n\n</div>"
    },
    {
      "text": "Key Responsibilities",
      "content": "<div>\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\"><strong><span style=\"font-size: 10.5pt; font-family: Calibri, sans-serif;\">DMPK Strategy &amp; Scientific Leadership</span></strong></p>\n\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Define and execute DMPK strategies across discovery and early development programs</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Design and interpret in vitro and in vivo studies to guide compound optimization and candidate selection</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Lead PK/PD modeling and exposure-response analyses to inform dosing strategies and translational plans</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Provide scientific leadership in understanding ADME properties</span></li>\n\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\">&nbsp;</p>\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\"><strong><span style=\"font-size: 10.5pt; font-family: Calibri, sans-serif;\">Cross-Functional Collaboration</span></strong></p>\n\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Partner closely with medicinal chemistry, biology, and project teams to integrate DMPK insights into compound design and program decisions</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Contribute to program strategy discussions, helping prioritize compounds and guide advancement decisions</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Collaborate with toxicology and clinical teams to ensure alignment across preclinical and translational efforts</span></li>\n\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\">&nbsp;</p>\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\"><strong><span style=\"font-size: 10.5pt; font-family: Calibri, sans-serif;\">External Vendor &amp; CRO Management</span></strong></p>\n\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Identify, select, and manage CRO partners and consultants to execute DMPK studies with high quality and efficiency</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Oversee study design, data interpretation, and reporting from external partners</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Ensure timelines, budgets, and deliverables are met across outsourced activities</span></li>\n\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\">&nbsp;</p>\n<p style=\"line-height: 1.2; margin-top: 0pt; margin-bottom: 0pt;\"><strong><span style=\"font-size: 10.5pt; font-family: Calibri, sans-serif;\">Regulatory &amp; Development Contributions</span></strong></p>\n\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Support IND-enabling activities, including preparation of DMPK sections for regulatory filings</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Contribute to interactions with regulatory agencies as needed</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">Ensure DMPK data packages meet regulatory expectations and support clinical development plans</span></li>\n\n</div>"
    },
    {
      "text": "Who You Are",
      "content": "<div>\n\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">You think like an owner—balancing scientific rigor with speed and pragmatism</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">You are both strategic and hands-on, comfortable zooming in and out as needed</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">You thrive in ambiguity and enjoy building as much as executing</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">You are collaborative, direct, and low-ego, with a focus on team success over individual recognition</span></li>\n<li style=\"line-height: 1.2;\"><span style=\"font-size: 10.5pt;\">You are motivated by the opportunity to make a meaningful impact for patients with serious disease</span></li>\n\n</div>"
    }
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  "createdAt": 1776307823181,
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    "team": "4:59 - Renasant Bio",
    "location": "Boston, MA",
    "commitment": "Full-time",
    "department": "4:59 Initiative",
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